This page shows what was measured, who it was measured in, and what that does not settle.
What Golimumab does in the body
Moderately to severely active rheumatoid arthritis
From the FDA-approved label: Golimumab is a human monoclonal antibody that binds to both the soluble and transmembrane bioactive forms of human TNFα. This interaction prevents the binding of TNFα to its receptors, thereby inhibiting the biological activity of TNFα (a cytokine protein). There was no evidence of the golimumab antibody binding to other TNF superfamily ligands; in particular, the golimumab antibody did not bind or neutralize human lymphotoxin. Golimumab did not lyse human monocytes expressing transmembrane TNF in the presence of complement or effector cells.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
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 · 91X1KLU43E · read 2026-08-29
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 105 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 people◇Read 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.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Energy
∅Nothing 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.
Which registered measures put each goal on this table
Energy
functional assessment of chronic illness therapy fatigue
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 people◇Read 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.
Number of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Month 6
✗ The study did not show it
Who was studied
NCT00975130
How many people
3366
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
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. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Number of Participants in Clinical Response Through Week 54
✗ The study did not show it
Who was studied
NCT00488631
How many people
1228
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
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. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Number of Participants With Clinical Response at Week 6
✗ The study did not show it
Who was studied
NCT00487539
How many people
1065
Study design
Phase 2/Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
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. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Quantitative ratio post booster vs. pre-booster of IgG against SARS-CoV-2 using electrochemiluminescent (ECL) technology against the receptor binding domain (RBD) of spike protein, stratified by treatment arm
✗ The study did not show it
Who was studied
NCT05080218
How many people
841
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
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. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
ACR20
✗ The study did not show it
Who was studied
NCT05046431
How many people
704
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
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. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Percentage of Participants with Clinical Remission at Week 48
✗ The study did not show it
Who was studied
NCT05242471
How many people
703
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
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. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 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 people◇Read 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.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.5 registered measures of this kind. No reviewed result.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
■Symptoms and quality of lifeEvidence recorded. Pain, tiredness, mood, sleep, as the person rated it.2 registered measures of this kind.
□A number that stands in for healthNo evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
□Cells in a dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□A guess from softwareNo 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 would be like to take◇Read 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.
health assessment questionnaire at week 24
functional assessment of chronic illness therapy fatigue
Measured
Things only a test, a scale or a device shows.
No registered study measured anything of this kind.
Meaningful
Things that change how a life goes, not only a number.
clinical remission
pd signals predict relapse at week 16
hospitalized infection or death
clinical remission at week 6 as assessed by the mayo
clinical remission at week 48
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 (33)
american college of rheumatology 20 response at week 14
an american college of rheumatology 50 response at week 14
clinical response at week 6
clinical response
acr 20 response
predicted forced vital capacity at week 16
an american college of rheumatology 20 response at week 14
disease activity
who experienced at least one adverse event
who experienced at least one serious adverse event
who discontinued study drug due to an ae
serious adverse events
incidence of adverse events
adverse events
surgical site infection
an infusion reaction through week 52
eular response criteria
good eular
treatment emergent adverse events and serious adverse events
individuals peak mmtt stimulated c peptide 0 017 pmol
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What is missing or unclear◇Read 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.
SIMPONI is a tumor necrosis factor (TNF) blocker indicated for the treatment of: adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate ( 1.1 ) adult patients with active psoriatic arthritis (PsA) alone, or in combination with methotrexate ( 1.2 ) adult patients with active ankylosing spondylitis (AS) ( 1.3 ) adult and pediatric patients weighing at least 15 kg…
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 in pediatric patients below the age of 2 years have not been established in pJIA or in PsA.”
US prescribing information · 9e260a47-55af-4c92-8d88-a86ccc767fff · read 2026-08-30
On older people, the label states: “In Trial RA, the number of patients ages 65 or older was too small to make comparisons with younger SIMPONI ARIA-treated patients.”
US prescribing information · 9e260a47-55af-4c92-8d88-a86ccc767fff · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Available data from postmarketing case reports with golimumab use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.”
US prescribing information · 9e260a47-55af-4c92-8d88-a86ccc767fff · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of SIMPONI ARIA in human milk, the effects on breastfed infants, or the effects on milk production.”
US prescribing information · 9e260a47-55af-4c92-8d88-a86ccc767fff · read 2026-08-30
Where the result stopped carrying
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 take◇Read 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 take◇Read 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
Injection
✎ 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
Sold as injectable, injection, solution, solution, given by the injection, subcutaneous, intravenous route.
✎ 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 take∅Nothing found in the sources checked
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.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
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.
Golimumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 228772 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
injection site pain — 36582 reaction mentions
arthralgia — 32083 reaction mentions
pain — 28914 reaction mentions
injection site erythema — 28046 reaction mentions
rheumatoid arthritis — 26240 reaction mentions
psoriasis — 17614 reaction mentions
injection site pruritus — 15404 reaction mentions
injection site swelling — 15132 reaction mentions
injection site reaction — 14682 reaction mentions
joint swelling — 14075 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 unclear◇Read 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
Injection
✎ 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
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
4 products list this as an active ingredient in the United States drug directory. 4 of them contain it and nothing else.
FDA National Drug Code directory · 57894-350 · read 2026-08-29
They are sold as injection, solution and solution, taken intravenous and subcutaneous.
FDA National Drug Code directory · 57894-350 · read 2026-08-29
The regulator's established pharmacologic class for it is tumor necrosis factor blocker [epc] and tumor necrosis factor receptor blocking activity [moa].
FDA National Drug Code directory · 57894-350 · read 2026-08-29
2 published labels name it as an active ingredient. 2 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 9e260a47-55af-4c92-8d88-a86ccc767fff · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 9e260a47-55af-4c92-8d88-a86ccc767fff · read 2026-08-29
SIMPONI ARIA is intravenous at 3 DOSAGE FORMS AND STRENGTHS Injection: 50 mg/4 mL (12.5 mg/mL) colorless to light yellow solution in a single-dose vial., recorded as fda label in effect 2025-09-09 in the United States.
US prescribing information · 9e260a47-55af-4c92-8d88-a86ccc767fff · read 2026-08-30
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 take◇Read 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 Golimumab 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 unclear◇Read 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 Golimumab 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 people◇Read 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.
Where else this substance is registered
FDA substance identifier (UNII)
91X1KLU43E
RxNorm concept
1431642
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
Suppression classes recorded: S1, S6.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read 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
2 approved applications cover products containing this substance. The earliest was BLA125289, approved 20090424 to CENTOCOR ORTHO BIOTECH INC.
This order is fixed in code and does not count clicks or time on the page.
What is not here
6 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
The path through the body — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
Claims that go past the evidence — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
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.
Recorded evidence blocks (11)
Q2
What did Golimumab's largest trial (105711 people) and its longest (32 years) measure?
105711 people in Golimumab's largest registered study, 32 years in its longest registered window, measuring Pharmacokinetics (area under the plasma concentration versus time curve [AUC] and Peak Plasma Concentration [Cmax]) of golimumab in Chinese male subjects. ClinicalTrials.gov · 2026-09-01
31 phase3, 21 na or unstated, 19 phase4, 18 phase2, 7 phase1, 2 na, 1 early phase1; NCT04725422; 2050-08; no ageing endpoint recorded. Last human test completed 2024, NCT02277444.
Interpretation These counts include studies where Golimumab 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
31
na or unstated
21
phase4
19
phase2
18
phase1
7
na
2
2 more recorded rows
early phase1
1
Last recorded human testNCT02277444
2024-09-27
recorded 2026-09-01 · last checked 2026-09-04
Q3
Golimumab was tested only in human — what did it show?
Interpretation Pharmacokinetics (area under the plasma concentration versus time curve [AUC] and Peak Plasma Concentration [Cmax]) of golimumab in Chinese male subjects — the recorded outcome words.
Show the evidence
humanNCT01288157
biomarker; Pharmacokinetics (area under the plasma concentration versus time curve [AUC] and Peak Plasma Concentration [Cmax]) of golimumab in Chinese male subjects; 96
recorded 2026-09-01 · last checked 2026-09-04
Q4
14 of Golimumab's trials stopped: safety, futility/efficacy, accrual/recruitment, other?
safety (4), futility/efficacy (1), accrual/recruitment (4) and other (5): Golimumab's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"Protocol was cancelled by company based on overall efficacy, no safety concern"; 14 of 96 registered studies
Show the evidence
Trial
NCT00488774
terminated; "Protocol was cancelled by company based on overall efficacy, no safety concern"
NCT01217814
terminated; "Due to delay in the study and the impact on the development timelines, not due to any identified safety concerns"
NCT01230827
terminated; "Trial has failed to meet primary - and major secondary endpoints"
NCT01526174
terminated; "House Research no longer conducting research."
NCT01602302
terminated; "low recruitment"
NCT01692457
withdrawn; "The company decided to cancel the study in conformity with Philippine FDA Circular 2013-004"
8 further recorded trials
NCT02390700
terminated; "Business decision based on lack of enrollment"
NCT02414984
terminated; "Insufficient enrollment (Terminated due to lack of patient recruitment)"
NCT02437162
terminated; "Neither dose achieved the study's primary or major secondary endpoints. The safety profile was consistent with previous ustekinumab studies."
NCT02438787
terminated; "This study was stopped because ustekinumab did not achieve key endpoints in a related study. The safety profile was consistent with past ustekinumab studies."
NCT02841176
terminated; "The study was stopped due to resourcing issues."
NCT03100253
terminated; "Slow recrutiment"
NCT04218565
terminated; "only one patient enrolled"
NCT04729296
withdrawn; "Withdrawn due to COVID-19 related clinical limitations"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Golimumab used Golimumab 100 mg — over how long?
7 recorded entries; human; also "Golimumab 100 mg", "Golimumab 50 mg", "Golimumab 200 mg"
Show the evidence
human
NCT00264550
Golimumab 100 mg
NCT00264550
Golimumab 50 mg
NCT00487539
Golimumab 200 mg
NCT00487539
Golimumab 400 mg
NCT00488774
Golimumab 1 mg per kg
NCT00488774
Golimumab 2 mg per kg
1 more recorded row
humanNCT00488774
Golimumab 4 mg per kg
recorded 2026-09-01 · last checked 2026-09-04
Q6
Which of acr 20 response, adhering to the allocated treatment and adverse events did Golimumab's trials measure?
acr 20 response, adhering to the allocated treatment and adverse events lead 40 outcome terms across Golimumab's trials. ClinicalTrials.gov · 2026-09-01
clinical response at week 6, clinical response, acr 20 response, predicted forced vital capacity at week 16, an american college of rheumatology 20 response at week 14 and disease activity follow.
Show the evidence
health assessment questionnaire at week 24
1
american college of rheumatology 20 response at week 14
1
an american college of rheumatology 50 response at week 14
1
clinical response at week 6
1
clinical response
1
acr 20 response
1
14 more recorded rows
predicted forced vital capacity at week 16
1
an american college of rheumatology 20 response at week 14
1
disease activity
1
functional assessment of chronic illness therapy fatigue
1
who experienced at least one adverse event
1
who experienced at least one serious adverse event
1
clinical remission
1
who discontinued study drug due to an ae
1
serious adverse events
1
pd signals predict relapse at week 16
1
incidence of adverse events
1
adverse events
1
surgical site infection
1
an infusion reaction through week 52
1
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which of Golimumab's 12 ongoing trials reports first?
Efficacy of Disease-modifying Antirheumatic Drugs Therapy for Rheumatoid Arthritis; Percentage of Participants With Clinical Remission at Week 6 as Assessed by the Mayo Score; latest 2050-08
Show the evidence
Trial
NCT03414502
"Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response"; n 400; "Efficacy of Disease-modifying Antirheumatic Drugs Therapy for Rheumatoid Arthritis"; 2029-03
NCT03596645
"A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis"; n 84; "Percentage of Participants With Clinical Remission at Week 6 as Assessed by the Mayo Score"; 2027-02-01
NCT04725422
"CHronic Nonbacterial Osteomyelitis International Registry"; n 2000; "The change of CNO disease activity score"; 2050-08
NCT05242471
"A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease"; n 703; "Percentage of Participants with Clinical Remission at Week 48"; 2029-11-05
NCT05242484
"A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis"; n 577; "Percentage of Participants with Clinical Remission at Week 48"; 2029-03-27
NCT05305066
"Stand UP to Rheumatoid Arthritis (SUPRA)"; n 75; "Rate of recruitment at two RA referral centers over 12 months"; 2030-12
6 further recorded trials
NCT05669833
"Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients"; n 63; "Achievement of cDAPSA low disease activity"; 2026-10
NCT05960578
"Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study"; n 8; "Prostate specific antigen (PSA)50 response rate"; 2027-04-14
NCT07138898
"Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty"; n 80; "Incidence of wound complications"; 2028-01
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
NCT07644117
"Individualizing Anti-TNF Therapy in Patients With Inflammatory Bowel Disease"; n 40; "Rates of clinical response in UC patients"; 2028-12
NCT07683026
"Platform Trial in Stage 1 Diabetes: Comparing Golimumab vs Placebo"; n 255; "Progression to Dysglycemia"; 2032-09-01
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which running trial of Golimumab 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.
1 open trial; n 4000; "Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population"
Show the evidence
TrialNCT07177209
"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
Q9
Which 25 trials of Golimumab posted no result?
Posted no result
25 of 25 completed trials
Registrations
NCT01362153, NCT01288157, NCT00771251, NCT00727987, NCT01212653 and NCT01718951, and 19 more
Completion dates
oldest 2009-02-27; newest 2023-07-10
Show the evidence
Trial
NCT01362153
2009-02-27
NCT01288157
2011-01
NCT00771251
2011-10
NCT00727987
2011-12
NCT01212653
2013-05
NCT01718951
2014-10
14 further recorded trials
NCT01081717
2015-05-31
NCT01295151
2015-11
NCT01219257
2016-01
NCT01988961
2016-01
NCT03496831
2017-12-31
NCT01871649
2018-11
NCT01426815
2019-03-18
NCT02728934
2020-01-31
NCT02758782
2021-01
NCT03298542
2021-06-01
NCT03955861
2021-07-17
NCT03632759
2021-11-09
NCT03182166
2021-12-15
NCT04772248
2021-12-30
Q10
At the median, Golimumab's trials enrolled 156 people — anything larger?
Median enrolment
156
Largest enrolment
105711
Registered trials counted
95
Q11
What do 228772 spontaneous reports say about Golimumab — 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.
Golimumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 228772 reaction mentions were counted: injection site pain 36582; arthralgia 32083; pain 28914; injection site erythema 28046. open-targets-adr · CHEMBL1201833 · 2026-06-24
Show the evidence
injection site pain
36582
arthralgia
32083
pain
28914
injection site erythema
28046
rheumatoid arthritis
26240
psoriasis
17614
4 more recorded rows
injection site pruritus
15404
injection site swelling
15132
injection site reaction
14682
joint swelling
14075
recorded 2026-06-24 · last checked 2026-09-04
Q12
Golimumab and CYP450 and Cytochrome P450: shared by which compounds?
CYP450 and Cytochrome P450 appear in Golimumab's recorded interaction sentences, 3 in all. openfda-label+europepmc · 2025-10-29
Interpretation drug_interactions
Show the evidence
Cytochrome P450drug_interactions
7.4 Cytochrome P450 Substrates The formation of CYP450 enzymes may be suppressed by increased levels of cytokines (e.g., TNFα) during chronic inflammation.
CYP450
drug_interactions
Therefore, it is expected that for a molecule that antagonizes cytokine activity, such as golimumab, the formation of CYP450 enzymes could be normalized.
drug_interactions
Upon initiation or discontinuation of SIMPONI 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 2025-10-29 · last checked 2026-09-04
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