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Adalimumab

  • Antibody medicine
  • Given by a clinician
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Adalimumab does in the body

Adalimumab binds TNF-alpha and reduces its ability to activate TNF receptors.

Your immune system uses a messenger protein called TNF-alpha to activate inflammation. In rheumatoid arthritis, too much of that signal reaches healthy joints. This lowers one source of inflammation; it does not switch off every inflammatory pathway.

Why people take it. Rheumatoid arthritis and other long-term inflammatory diseases

What happened in people

ACR20 at 24 weeks of 67.2% with adalimumab plus methotrexate versus 14.5% with methotrexate alone

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.

The limit that matters most

That sustained remission on adalimumab means the disease can be treated as cured; no pivotal trial randomised responders to withdrawal

Where it acts
Extracellular fluid, inflamed synovium and gut mucosa
Kind of result
The kind of result is not recorded
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • The substance registry classes this as protein.

    FDA substance registry · FYS6T7F842 · read 2026-08-29

Where each sentence above came from

A person wrote this explanation into the record, with the studies named in the path below.

The recorded use, written for a reader without medical training. Not signed off.

A limit recorded against this substance. Not signed off as a reviewed claim.

The four opening statements run to 72 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

Placebo

A placebo is a dummy treatment given so the real one can be compared with it.

A picture of it, and where the picture fails

A placebo is like a blank control in an experiment.

Where that stops being true. A blank does nothing. People given a placebo often do get better.

What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.

An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.

Comparator

A comparator is whatever the treatment was measured against.

A picture of it, and where the picture fails

It is like the other runner in a race.

Where that stops being true. A race has one winner. A study can show both arms improved.

What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.

The control condition against which the experimental intervention is assessed.

What happened in peopleRead from sources, not yet reviewed

What was measured, goal by goal

One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.

Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.

There is no single score. A strong test result and a weak life result are different facts.

Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
PainNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Waiting for a reviewer1 registered symptom measure.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
FocusNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
SleepNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Pain
leg pain
Focus
cd27+ switched memory b cells at week 12
Sleep
sleep apnea per hour

Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.

What each mark on this table means
Nothing in the sources checked
No registered study lists a life outcome for this goal.
Waiting for a reviewer
1 registered symptom measure.
Not recorded
Harms were not a registered measure for this goal.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

ACR20 response at week 24 on background methotrexate

The study showed what it set out to show

Who was studied
ARMADA (Weinblatt 2003, conducted before ClinicalTrials.gov registration)
How many people
271
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
p < 0.001 for each adalimumab dose versus placebo
Repeated elsewhere
Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous prefilled syringe or autoinjector pen

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

ACR50 at year 1 and change in modified total Sharp score at year 2, methotrexate-naive early rheumatoid arthritis

The study showed what it set out to show

Who was studied
PREMIER (Breedveld 2006)
How many people
799
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
p < 0.001 for combination versus either monotherapy
Repeated elsewhere
Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous prefilled syringe or autoinjector pen

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

What we know
RNAWiki holds 2 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What happened in peopleRead from sources, not yet reviewed

How close this is to real life

The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.

  1. Living longer, or avoiding a major event Evidence recorded. Death, a heart attack, a stroke, a hospital stay.3 registered measures of this kind. No reviewed result.
  2. What a body can do day to day Evidence recorded. Walking, dressing, breathing, recovering.1 registered measure of this kind.
  3. Measured performance Evidence recorded. How much was lifted, how far was run, how fast.1 registered measure of this kind.
  4. Symptoms and quality of life Evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.1 registered measure of this kind.
  5. A number that stands in for health No evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.1 registered measure inside human tissue.
  7. Animals No evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
  8. Cells in a dish Evidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

Higher on these steps means closer to something a person would feel. It does not mean better done.

What it changes in the bodyRead from sources, not yet reviewed

The path through the body

From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.

Where a source records it acting

  • Joints: Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in moderately to severely active rheumatoid arthritis

    US prescribing information · 08dbaffe-9d05-43cf-b24b-b44ade8685fc · read 2026-08-27

  • Intestines: Treatment of moderately to severely active Crohn’s disease and ulcerative colitis

    US prescribing information · 08dbaffe-9d05-43cf-b24b-b44ade8685fc · read 2026-08-27

  • Skin: Treatment of moderate to severe chronic plaque psoriasis in candidates for systemic therapy or phototherapy

    US prescribing information · 08dbaffe-9d05-43cf-b24b-b44ade8685fc · read 2026-08-27

  • Eyes: Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients

    US prescribing information · 08dbaffe-9d05-43cf-b24b-b44ade8685fc · read 2026-08-27

  1. Start

    Adalimumab

    What a person takes: Subcutaneous prefilled syringe or autoinjector pen.

    The measurement behind this step

    Single-use 40 mg/0.4 mL or 40 mg/0.8 mL device self-administered every other week, with loading regimens for gastrointestinal and dermatological indications.

  2. Getting in

    Subcutaneous injection and lymphatic uptake

    A short needle deposits the antibody just under the skin. From there it drains slowly into the lymph system and reaches the blood over the following days.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    A 148 kDa IgG1 is too large for direct capillary uptake, so absorption is via lymphatic convection with a time to peak concentration of roughly five days and absolute bioavailability near 64%.

  3. Reaching the cell

    FcRn recycling keeps it in circulation for two weeks

    Cells lining the blood vessels swallow the antibody, then deliberately spit it back out instead of digesting it. That salvage loop is why one injection lasts a fortnight.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    The IgG1 Fc binds the neonatal Fc receptor at endosomal pH 6.0 and is released at extracellular pH 7.4, diverting the molecule out of the lysosomal route. Terminal half-life is approximately 14 days.

  4. What it acts on

    Binding soluble and membrane TNF-alpha

    The two arms of the antibody clamp onto the inflammatory messenger, both the free-floating form and the form still anchored to a cell surface.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Both Fab arms bind the TNF-alpha homotrimer with sub-nanomolar affinity, forming immune complexes with soluble TNF and coating transmembrane TNF on activated macrophages and T cells.

  5. The change it makes

    Receptor engagement is blocked and signalling stops

    With the messenger held, it can no longer dock on the receptors that would have told cells to inflame the joint.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Occupied TNF cannot engage TNFR1 or TNFR2, so the TRADD-RIPK1-NF-kB and MAPK cascades are not initiated. Downstream IL-6, IL-1, chemokine and adhesion-molecule transcription falls, and matrix metalloproteinase release from synovial fibroblasts declines.

  6. What that does for a person

    Synovitis settles and erosion slows

    Swelling and morning stiffness fall within weeks. On X-rays taken a year or two apart, the joint surface is measurably better preserved than it would have been.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Reduced RANKL-driven osteoclast activation and reduced MMP-mediated cartilage degradation translate into slower progression of the modified total Sharp score, the endpoint PREMIER measured over two years.

No suggested links are held for this record, so nothing is hidden from this path.

What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.

What it would be like to takeRead from sources, not yet reviewed

Felt, measured, or meaningful

Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.

Felt

Things a person could notice without a test.

  • leg pain

Measured

Things only a test, a scale or a device shows.

  • gene expression in the peripheral blood mononuclear cells

Meaningful

Things that change how a life goes, not only a number.

  • clinical remission
  • achieving clinical remission
  • health assessment questionnaire disability index
  • disease activity 28 joints remission at week 24

A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.

Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.

Measured, but not felt. A number moves. The person notices nothing. Both can be true.

Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.

Matters, but takes years. The result that counts may take longer than anyone would keep watching.

Names that fit none of the three (34)
  • safety
  • safety and tolerance of medications
  • modified total sharp at week 52
  • corticoid reduction and das 28
  • clinical response
  • job loss measurement
  • american college of rheumatology 20 response rate
  • safety parameters
  • acr20
  • reported outcomes
  • disease activity
  • at least one serious infection through week 24
  • any infections or any grade 3/4 infections through week 24
  • maximum duration of infections through week 24
  • adverse events and serious adverse events through week 24
  • acr20 response
  • basdai
  • psoriasis area and severity index
  • adverse events
  • who achieve a das28 3 2

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

What it would be like to takeRead from sources, not yet reviewed

How long anything takes

Nine different lengths of time that get confused with each other. None of them is worked out from another.

  1. Before anything is noticed. RNAWiki does not store this separately, and never works it out from another figure on this page.

  2. Before a test result moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  3. Before performance moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  4. How long the result was watched. No finished study window is recorded for a study that tested this substance.

  5. How long people took it. How long people actually took it is not stored. The study window is not the same thing.

  6. How long people were followed. Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.

  7. How fast the body clears it. approximately 2 weeks, ranging from 10 to 20 days across studies

    Read from the label, which states: “The mean terminal half-life was approximately 2 weeks, ranging from 10 to 20 days across studies. Healthy subjects and patients with RA displayed similar adalimumab pharmacokinetics.”

  8. How long effects linger. RNAWiki does not store this separately, and never works it out from another figure on this page.

  9. Beyond the studies. Nothing is recorded about the long term.

    The longest finished study sets the edge of what anyone measured.

A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • Adults and children with moderate-to-severe inflammatory disease that methotrexate or another conventional agent has not controlled. Adalimumab was the best-selling drug in the world for most of the decade to 2022.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “The safety and effectiveness of adalimumab products have not been established in pediatric patients with JIA less than 2 years of age.”

    US prescribing information · cd0e7af2-7704-49ce-bde9-f645294b6788 · read 2026-08-30

  • On older people, the label states: “A total of 519 RA patients 65 years of age and older, including 107 patients 75 years of age and older, received adalimumab in clinical studies RA-I through IV.”

    US prescribing information · cd0e7af2-7704-49ce-bde9-f645294b6788 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects.”

    US prescribing information · cd0e7af2-7704-49ce-bde9-f645294b6788 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary Limited data from case reports in the published literature describe the presence of adalimumab in human milk at infant doses of 0.1% to 1% of the maternal serum concentration.”

    US prescribing information · cd0e7af2-7704-49ce-bde9-f645294b6788 · read 2026-08-30

Where the result stopped carrying

  • Murine and chimeric anti-TNF constructs provoked anti-drug antibodies; adalimumab was the first fully human anti-TNF antibody, isolated by phage display
  • US biosimilar competition was delayed to 2023 by a patent estate of 132 granted patents while European biosimilars launched in 2018
  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied for a different goal

The studies measured something else entirely.

On this record: Some registered studies measured things that match no goal on this page.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Given by a clinician

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Subcutaneous prefilled syringe or autoinjector pen

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S1, S6.

No source is stored against this line.

What is in the pack

8 mL device self-administered every other week, with loading regimens for gastrointestinal and dermatological indications.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeRead from sources, not yet reviewed

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Worth asking a clinician aboutWritten into the record from the studies named on this page

Injection site reactions are the commonest event. Serious infection risk is roughly doubled against placebo in pooled trials, with tuberculosis reactivation, invasive fungal infection and hepatitis B reactivation carrying boxed warnings alongside lymphoma and other malignancy.

Nobody counted how many people took this and were fine, so this cannot be turned into a rate.

Where this came from

Reports sent to a regulator

  • These are reports people sent to a regulator. They do not show the medicine caused the reaction.
  • Nobody counted how many people took the medicine and reported nothing.
  • The same event can be reported more than once, and many reports are incomplete.
  • News coverage, lawsuits and new warnings change how often people report.
  • A count is not a rate and not a risk.

Adalimumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 228957 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • injection site pain — 36582 reaction mentions
  • arthralgia — 32168 reaction mentions
  • pain — 28914 reaction mentions
  • injection site erythema — 28046 reaction mentions
  • rheumatoid arthritis — 26240 reaction mentions
  • psoriasis — 17665 reaction mentions
  • injection site pruritus — 15404 reaction mentions
  • injection site swelling — 15132 reaction mentions
  • injection site reaction — 14682 reaction mentions
  • joint swelling — 14124 reaction mentions
  • open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Subcutaneous prefilled syringe or autoinjector pen

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

nal and dermatological indications.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on which forms are sold and how they compare.

No source is stored against this line.

What is recorded as being sold

  • 62 products list this as an active ingredient in the United States drug directory. 62 of them contain it and nothing else.

    FDA National Drug Code directory · 72511-399 · read 2026-08-29

  • They are sold as injection, injection, solution, liquid and solution, taken subcutaneous.

    FDA National Drug Code directory · 72511-399 · read 2026-08-29

  • The regulator's established pharmacologic class for it is antibodies, monoclonal [cs] and tumor necrosis factor blocker [epc].

    FDA National Drug Code directory · 72511-399 · read 2026-08-29

  • 16 published labels name it as an active ingredient. 16 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · cd0e7af2-7704-49ce-bde9-f645294b6788 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · cd0e7af2-7704-49ce-bde9-f645294b6788 · read 2026-08-29

  • IDACIO is injection: single-dose prefilled pen, single-dose prefilled glass syringe, or single-dose glass vial kit for institutional use at 40 mg/0.8 mL, recorded as prescription biologic; fda label in effect 2024-10-15 in the United States.

    US prescribing information · 08dbaffe-9d05-43cf-b24b-b44ade8685fc · read 2026-08-27

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Adalimumab studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

Claims that go past the evidence

Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.

Goes past the evidence

That sustained remission on adalimumab means the disease can be treated as cured; no pivotal trial randomised responders to withdrawal

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That being the best-selling drug in the world implies superiority over other anti-TNF agents; the pivotal trials were placebo-controlled, not head-to-head

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That the 2006 pooled malignancy odds ratio of 3.3 is the current estimate; registry data did not confirm an overall excess

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Adalimumab are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Every line above can be traced to the study named beside it. Follow the link and read it.

ARMADA: ACR20 rose from 14.5% to 67.2% when adalimumab was added to methotrexate
In plain words
In 271 people whose rheumatoid arthritis was still active on methotrexate, adding fortnightly adalimumab raised the proportion with a 20% improvement at six months from 15 in 100 to 67 in 100.
What was measured
ACR20 response at 24 weeks: 67.2% versus 14.5%
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Randomised, double-blind, placebo-controlled 24-week trial. ACR20 at week 24 was 47.8%, 67.2% and 65.8% for adalimumab 20 mg, 40 mg and 80 mg every other week on background methotrexate, versus 14.5% for methotrexate plus placebo. The 40 mg dose became the marketed regimen.
Source
Weinblatt et al., Arthritis & Rheumatism 2003 (ARMADA)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
PREMIER: combination therapy beat either drug alone on joint damage, not just symptoms
In plain words
In 799 people with early aggressive disease who had never had methotrexate, the combination slowed the erosion visible on X-rays more than either drug used alone.
What was measured
ACR50 at 1 year: 62% combination versus 46% and 41% monotherapy
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Two-year, multicentre, double-blind, active-comparator trial. ACR50 at year 1 was 62% for adalimumab plus methotrexate versus 46% for methotrexate and 41% for adalimumab monotherapy. Combination therapy was superior on radiographic progression and clinical remission as well as on signs and symptoms.
Source
Breedveld et al., Arthritis & Rheumatism 2006 (PREMIER)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The 2006 cancer signal that later cohorts did not confirm
In plain words
A 2006 pooled analysis of trials suggested anti-TNF antibodies roughly tripled cancer risk. Larger real-world registries assembled over the following five years did not reproduce an overall excess, and the field moved from alarm to qualified reassurance.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Bongartz et al. pooled nine randomised trials (3,493 treated, 1,512 placebo) and reported a malignancy odds ratio of 3.3 (95% CI 1.2-9.1), number needed to harm 154 over 6-12 months, plus a serious infection odds ratio of 2.0 (95% CI 1.3-3.1). A 2011 systematic review of registries and prospective observational cohorts by Mariette et al. did not confirm an overall malignancy excess, though signals for non-melanoma skin cancer persisted. The serious infection finding has held up better than the malignancy one.
Source
Bongartz et al., JAMA 2006; superseded on malignancy by Mariette et al., Annals of the Rheumatic Diseases 2011
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim
Remission on the drug is read as remission from the disease
In plain words
Marketing and patient conversation both slide from "my disease is quiet" to "my disease is gone". The trials measured the first and never tested the second.
What was measured
That achieving remission on adalimumab means the disease has been cured
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
ARMADA and PREMIER measured response and radiographic progression during continuous treatment. Neither trial randomised sustained responders to withdrawal, so neither can support a claim about drug-free remission. Later withdrawal studies in early rheumatoid arthritis show that a minority maintain remission off biologic therapy and that predictors of who they are remain unsettled.
Source
Trial design of Weinblatt 2003 and Breedveld 2006
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
Patent thicket delayed US biosimilar competition by five years
In plain words
The same molecule faced competition in Europe from 2018 and in the United States only from 2023. The gap was created by patents on formulation, manufacturing and uses rather than on the antibody itself.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The 2021 House Oversight staff report, drawing on 170,000 pages of internal documents, describes AbbVie filing 247 patent applications and obtaining 132 patents on Humira, more than 90% issued within two years of the primary composition-of-matter patent expiring. Amgen launched Amjevita in the United States in January 2023 at two list prices, roughly 5% and 55% below Humira. The market failure here is in access, not in the antibody.
Source
US House Committee on Oversight and Reform, Drug Pricing Investigation: AbbVie — Humira and Imbruvica (May 2021)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim

Where else this substance is registered

RxNorm concept
327361

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What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 1 approved application covers products containing this substance. The earliest was BLA125057, approved 20021231 to ABBVIE INC.

    Drugs@FDA application register · BLA125057 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · BLA125057 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20181106.

    FDA National Drug Code directory · 72511-399 · read 2026-08-29

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Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

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A fully human antibody that mops up TNF-alpha before it reaches its receptor, raising the 24-week ACR20 response rate from 14.5% on methotrexate alone to 67.2% when added to it.

Recorded evidence blocks (14)

What did Adalimumab's largest trial (105711 people) and its longest (32 years) measure?


105711 people in Adalimumab's largest registered study, 32 years in its longest registered window, measuring To characterize the concentration-effect relationship of adalimumab in rheumatoid arthritis. ClinicalTrials.gov · 2026-09-01

172 phase3, 109 phase4, 87 phase2, 58 na or unstated, 35 phase1, 19 na, 1 early phase1; NCT04725422; 2050-08. Last human test completed 2026, NCT05814627.

Interpretation These counts include studies where Adalimumab was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.

Show the evidence
  • phase3
    172
  • phase4
    109
  • phase2
    87
  • na or unstated
    58
  • phase1
    35
  • na
    19
2 more recorded rows
  • early phase1
    1
  • Last recorded human test NCT05814627
    2026-07-15

recorded 2026-09-01 · last checked 2026-09-04

Adalimumab was tested only in human — what did it show?


human: biomarker (466): the rungs where Adalimumab has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation To characterize the concentration-effect relationship of adalimumab in rheumatoid arthritis — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human biomarker
Show the evidence
  • human NCT01382160
    biomarker; To characterize the concentration-effect relationship of adalimumab in rheumatoid arthritis; 466

recorded 2026-09-01 · last checked 2026-09-04

37 of Adalimumab's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, sponsor decision unspecified, other?


safety (3), futility/efficacy (1), accrual/recruitment (14), funding/business (4), sponsor decision unspecified (2) and other (13): Adalimumab's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Study terminated due to low subject enrollment. Safety results consistent with product label."; 37 of 466 registered studies

Show the evidence

Trial

  • NCT00233558
    terminated; "Study terminated due to low subject enrollment. Safety results consistent with product label."
  • NCT00298272
    terminated; "Sponsor decided to end long term extension phase for business reasons unrelated to safety."
  • NCT00311246
    terminated; "Difficulty in recruiting subjects"
  • NCT00690846
    withdrawn; "Dr. Jorizzo has withdrawn from this study due to time it is taking to start"
  • NCT00690911
    withdrawn; "Dr. Jorizzo has decided to withdraw from this study due to the time it is taking to get the study started."
  • NCT00761514
    terminated; "The study was terminated due to low enrollment."
14 further recorded trials
  • NCT00796705
    terminated; "Lack of Enrollment"
  • NCT00972218
    withdrawn; "Difficulty with enrollment"
  • NCT01078610
    withdrawn; "Study stopped prior to enrollment."
  • NCT01264770
    terminated; "AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Rigel Pharmaceuticals."
  • NCT01283971
    terminated; "The study was closed due to the slow enrollment rate."
  • NCT01562951
    terminated; "Not enough patient population according to selection criteria to complete the study"
  • NCT01602302
    terminated; "low recruitment"
  • NCT01674413
    withdrawn; "Unable to recruit; all patients interested simply wanted to stop medication"
  • NCT01704599
    terminated; "side effect and poor clinical outcome"
  • NCT01716039
    terminated; "Unable to achieve recruitment target."
  • NCT01764997
    terminated; "Due to small number of participants entering randomization. Not a safety issue."
  • NCT01870284
    withdrawn; "Due to unexpected operational issues outside of Lilly's control the study has been closed"
  • NCT01986127
    terminated; "slow recruitment"
  • NCT02092961
    terminated; "AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Rigel Pharmaceuticals."

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Adalimumab used DB adalimumab 40 mg eow — over how long?


studies of Adalimumab used the recorded amount. ClinicalTrials.gov · 2026-09-01

16 recorded entries; human; subcutaneous, injection; also "DB adalimumab 40 mg eow", "DB adalimumab 40 mg ew", "OL adalimumab 40 mg"

Show the evidence

human

  • NCT00055497
    DB adalimumab 40 mg eow
  • NCT00055497
    DB adalimumab 40 mg ew
  • NCT00055497
    OL adalimumab 40 mg
  • NCT00233571
    subcutaneous; Adalimumab 40 mg subcutaneous (SC) every other week (EOW)
  • NCT00296894
    Adalimumab (40 mg sc every other week)
  • NCT00538902
    Adalimumab 80 mg
10 more recorded rows
  • human NCT00538902
    Adalimumab 40 mg
  • human NCT01070303
    Adalimumab 40 mg eow or ew
  • human NCT01320293
    Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]
  • human NCT02019472
    adalimumab 40 mg
  • human NCT02760407
    Adalimumab 40mg q2w
  • human NCT03464136
    Adalimumab (40 mg)
  • human NCT04018599
    40 mg MSB11022
  • human NCT04131322
    Amgevita 40Mg Solution for Injection
  • human NCT04131322
    HUMIRA 40Mg Solution for Injection
  • human NCT07423533
    injection; adalimumab injection 40 mg

recorded 2026-09-01 · last checked 2026-09-04

Adalimumab's half-life is approximately 2 weeks, ranging from 10 to 20 days across studies — which schedules were studied?


approximately 2 weeks, ranging from 10 to 20 days across studies, the half-life Adalimumab's label states. openfda-label · b7178e36-6787-45ab-8fee-be59bc6a4aa4 · 2026-08-27

bioavailability 64% %.

Show the evidence
  • half life
    approximately 2 weeks, ranging from 10 to 20 days across studies; The mean terminal half-life was approximately 2 weeks, ranging from 10 to 20 days across studies. Healthy subjects and patients with RA displayed similar adalimumab pharmacokinetics.
  • bioavailability
    64% %; The average absolute bioavailability of adalimumab following a single 40 mg subcutaneous dose was 64%.

recorded 2026-08-27 · last checked 2026-09-04

Which of achieving clinical remission, achieving clinical response at week 16 and acr20 did Adalimumab's trials measure?


achieving clinical remission, achieving clinical response at week 16 and acr20 lead 40 outcome terms across Adalimumab's trials. ClinicalTrials.gov · 2026-09-01

modified total sharp at week 52, achieving clinical remission, corticoid reduction and das 28, clinical response, job loss measurement and american college of rheumatology 20 response rate follow.

Show the evidence
  • clinical remission
    1
  • safety
    1
  • safety and tolerance of medications
    1
  • modified total sharp at week 52
    1
  • achieving clinical remission
    1
  • corticoid reduction and das 28
    1
14 more recorded rows
  • clinical response
    1
  • job loss measurement
    1
  • american college of rheumatology 20 response rate
    1
  • health assessment questionnaire disability index
    1
  • safety parameters
    1
  • acr20
    1
  • reported outcomes
    1
  • disease activity
    1
  • at least one serious infection through week 24
    1
  • any infections or any grade 3/4 infections through week 24
    1
  • maximum duration of infections through week 24
    1
  • adverse events and serious adverse events through week 24
    1
  • acr20 response
    1
  • leg pain
    1

recorded 2026-09-01 · last checked 2026-09-04

Which of Adalimumab's 53 ongoing trials reports first?


53 registered trials of Adalimumab are open; earliest completion 2023-12-31. ClinicalTrials.gov · 2026-09-01

Psoriasis Area Severity Index (PASI); Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12; latest 2050-08

Show the evidence

Trial

  • NCT01706692
    "Swiss Dermatology Network of Targeted Therapies (SDNTT)"; n 1121; "Psoriasis Area Severity Index (PASI)"; 2032-03-15
  • NCT02629159
    "A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate"; n 1629; "Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12"; 2027-09-30
  • NCT02706704
    "Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis"; n 32; "Vitreous Haze"; 2026-02
  • NCT03261102
    "TDM Guided Early Optimization of ADAL in Crohn's Disease"; n 200; "Proportion of subjects who achieved remission"; 2025-06-01
  • NCT03414502
    "Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response"; n 400; "Efficacy of Disease-modifying Antirheumatic Drugs Therapy for Rheumatoid Arthritis"; 2029-03
  • NCT03681652
    "Post-Operative Crohn's Disease Outcome in Children"; n 100; "Endoscopic recurrence (Rutgeerts score ≥ i2b)"; 2027-03-01
14 further recorded trials
  • NCT03917303
    "Control Crohn Safe Trial"; n 158; "Number of yearly-quarters of corticosteroid free remission as a measure of treatment efficacy"; 2026-09
  • NCT03938701
    "Fluorescence Imaging of IBD and RA Using Adalimumab-800CW"; n 36; "Safety: number of participants with symptoms or changes in vital signs (blood pressure, heart rate and temperature) that are related to administration of adalimumab-800CW"; 2026-08-01
  • NCT04088409
    "A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis"; n 30; "Part A: Percentage of Responders for Baricitinib at Week 24"; 2028-07
  • NCT04183608
    "A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab"; n 238; "Endoscopic Remission"; 2028-05
  • NCT04300686
    "A Pilot Study in Severe Patients With Takayasu Arteritis."; n 40; "Disease remission at 24 weeks."; 2023-12-31
  • NCT04527380
    "A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis"; n 101; "Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 (Ixekizumab - OLT Period)"; 2029-01
  • NCT04646187
    "De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease"; n 148; "cumulative incidence of out-of-range fecal calprotectin results at 48 weeks follow-up"; 2026-03
  • NCT04725422
    "CHronic Nonbacterial Osteomyelitis International Registry"; n 2000; "The change of CNO disease activity score"; 2050-08
  • NCT04909801
    "A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate"; n 338; "Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24"; 2027-09-01
  • NCT05108259
    "To Compare the Pharmacokinetics and Safety of PBP1502 and Humira in Healthy Subjects"; n 324; "Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf)"; 2026-05
  • NCT05169593
    "Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy"; n 292; "postoperative endoscopic recurrence (Rutgeerts score ≥i2b)"; 2030-10
  • NCT05305066
    "Stand UP to Rheumatoid Arthritis (SUPRA)"; n 75; "Rate of recruitment at two RA referral centers over 12 months"; 2030-12
  • NCT05535738
    "Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation"; n 45; "To collect and evaluate single-cell multiomics data (RNAseq, CITEseq, TCRseq)"; 2027-12-31
  • NCT05590455
    "Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis"; n 130; "3-month all-cause mortality"; 2027-12

recorded 2026-09-01 · last checked 2026-09-04

Which running trial of Adalimumab could settle inflammatory markers?


NCT07177209 measures Proportion of patients that achieve early control of inflammation on conventional therapeutics within 6-24 months of UC diagnosis., reading out 2026-07-31.

2 open trials; n 4000; "Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population"

Show the evidence

Trial

  • NCT07177209
    "Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population"; n 4000; "Proportion of patients that achieve early control of inflammation on conventional therapeutics within 6-24 months of UC diagnosis."; 2026-07-31
  • NCT05590455
    "Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis"; n 130; "3-month all-cause mortality"; 2027-12

Which 115 trials of Adalimumab posted no result?


Posted no result
115 of 115 completed trials
Registrations
NCT00649922, NCT00647491, NCT00185562, NCT00233571, NCT01270087 and NCT00133315, and 109 more
Completion dates
oldest 2005-02; newest 2024-08-01
Show the evidence

Trial

  • NCT00649922
    2005-02
  • NCT00647491
    2005-08
  • NCT00185562
    2006-01
  • NCT00233571
    2006-06
  • NCT01270087
    2007-02
  • NCT00133315
    2007-04
14 further recorded trials
  • NCT00338650
    2007-05
  • NCT00696059
    2007-07
  • NCT00193648
    2007-10
  • NCT00421642
    2008-04
  • NCT00470509
    2008-06
  • NCT00827996
    2008-08
  • NCT00234234
    2008-12
  • NCT00497614
    2008-12
  • NCT00296894
    2009-02
  • NCT02252809
    2009-07
  • NCT00686439
    2010-11
  • NCT00597623
    2010-12
  • NCT00814866
    2011-03
  • NCT00305539
    2011-05

At the median, Adalimumab's trials enrolled 130 people — anything larger?


Median enrolment
130
Largest enrolment
105711
Registered trials counted
463

What do 228957 spontaneous reports say about Adalimumab — and not say?


These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

Adalimumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 228957 reaction mentions were counted: injection site pain 36582; arthralgia 32168; pain 28914; injection site erythema 28046. open-targets-adr · CHEMBL1201580 · 2026-06-24

Show the evidence
  • injection site pain
    36582
  • arthralgia
    32168
  • pain
    28914
  • injection site erythema
    28046
  • rheumatoid arthritis
    26240
  • psoriasis
    17665
4 more recorded rows
  • injection site pruritus
    15404
  • injection site swelling
    15132
  • injection site reaction
    14682
  • joint swelling
    14124

recorded 2026-06-24 · last checked 2026-09-04

Adalimumab and CYP450 and Cytochrome P450: shared by which compounds?


CYP450 and Cytochrome P450 appear in Adalimumab's recorded interaction sentences, 3 in all. openfda-label+europepmc · 2026-07-13

Interpretation drug_interactions

Show the evidence
  • Cytochrome P450 drug_interactions
    7.4 Cytochrome P450 Substrates The formation of CYP450 enzymes may be suppressed by increased concentrations of cytokines (e.g., TNFα, IL-6) during chronic inflammation.

CYP450

  • drug_interactions
    It is possible for products that antagonize cytokine activity, such as adalimumab products, to influence the formation of CYP450 enzymes.
  • drug_interactions
    Upon initiation or discontinuation of AMJEVITA in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed.

recorded 2026-07-13 · last checked 2026-09-04

Was Adalimumab studied with exercise?


exercise is named in Adalimumab's label sentences: "For each participant, adalimumab 40 mg/0.8 mL/2 wk was injected and a 3-session exercise program per week for 1 month was prescribed." openfda-label+europepmc · 2026-07-13

1 recorded statement; exercise

Show the evidence
  • exercise
    For each participant, adalimumab 40 mg/0.8 mL/2 wk was injected and a 3-session exercise program per week for 1 month was prescribed.

recorded 2026-07-13 · last checked 2026-09-04

What is recorded about Adalimumab and AMPK?


"Corresponding targeted medications such as Abatacept, chemokine receptor (CCR) inhibitors, CDDO-Im (2-Cyano-3,12-dioxooleana-1,9-dien-28-imidazolide), adenosine monophosphate-activated protein kinase (AMPK) activators, and Adalimumab are currently under investigation." — where Adalimumab and AMPK appear together. Europe PMC · pathway abstract search · 2026-03-17

AMPK, autophagy, mTOR, sirtuin; PMID 39935575, 41856464, 25345753

Show the evidence
  • AMPK PMID 39935575
    "Corresponding targeted medications such as Abatacept, chemokine receptor (CCR) inhibitors, CDDO-Im (2-Cyano-3,12-dioxooleana-1,9-dien-28-imidazolide), adenosine monophosphate-activated protein kinase (AMPK) activators, and Adalimumab are currently under investigation."
  • autophagy PMID 41856464
    "We categorize the HDT candidates by their targeted host pathways, including autophagy (metformin, vitamin D, all-trans retinoic acid), inflammatory signaling (nonsteroidal anti-inflammatory drugs), immunomodulation (corticosteroids), matrix metalloproteinase inhibition (doxycycline), lipid metabolism (statins, PSCK9 inhibitors), tumor necrosis factor-⍺ inhibitors (adalimumab, infliximab), redox…"
  • mTOR PMID 25345753
    "These strategies include: approaches targeting IKK-b-NF-kB (salicylates, salsalate), TNF-α (etanercept, infliximab, adalimumab), IL-1β (anakinra, canakinumab) and IL-6 (tocilizumab), AMP-activated protein kinase activators, sirtuin-1 activators, mammalian target of rapamycin inhibitors and C-C motif chemokine receptor 2 antagonists."
  • AMPK PMID 25345753
    "These strategies include: approaches targeting IKK-b-NF-kB (salicylates, salsalate), TNF-α (etanercept, infliximab, adalimumab), IL-1β (anakinra, canakinumab) and IL-6 (tocilizumab), AMP-activated protein kinase activators, sirtuin-1 activators, mammalian target of rapamycin inhibitors and C-C motif chemokine receptor 2 antagonists."
  • sirtuin PMID 25345753
    "These strategies include: approaches targeting IKK-b-NF-kB (salicylates, salsalate), TNF-α (etanercept, infliximab, adalimumab), IL-1β (anakinra, canakinumab) and IL-6 (tocilizumab), AMP-activated protein kinase activators, sirtuin-1 activators, mammalian target of rapamycin inhibitors and C-C motif chemokine receptor 2 antagonists."

recorded 2026-03-17 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1201580
CAS number
331731-18-1
RxCUI
327361
Also called
Abp-501, Abrilada, Adalimumab aacf, Adalimumab-aaty, Adalimumab adaz, Adalimumab adbm, Adalimumab afzb, Adalimumab aqvh, Adalimumab atto, Adalimumab biosimilar (alvotech), Adalimumab bwwd, Adalimumab fkjp
International name
Adalimumab beta
Trade name
Amgevita, Halimatoz, Hefiya, Humira, Imraldi, Kromeya, Libmyris, Solymbic
Development code
AVT-02, BI695501, CT-P17, CTP17, D2E7, D3E7, FKB-327, FKB327, GP2017, HLX-03, HLX03, LU-200134
Sources (10)

Sources

4 more sources
  • open-targets-adr CHEMBL1201580 ·
  • openfda-label b7178e36-6787-45ab-8fee-be59bc6a4aa4 ·
  • openfda-label+europepmc K1:FYS6T7F842 ·
  • national registers US, EU, CA ·

ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 10 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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