This page shows what was measured, who it was measured in, and what that does not settle.
What Certolizumab pegol does in the body
Moderately to severely active rheumatoid arthritis
From the FDA-approved label: Certolizumab pegol binds to human TNFα with a KD of 90pM. TNFα is a key pro-inflammatory cytokine with a central role in inflammatory processes. Certolizumab pegol selectively neutralizes TNFα (IC 90 of 4 ng/mL for inhibition of human TNFα in the in vitro L929 murine fibrosarcoma cytotoxicity assay) but does not neutralize lymphotoxin α (TNFβ). Certolizumab pegol cross-reacts poorly with TNF from rodents and rabbits, therefore in vivo efficacy was evaluated using animal models in which human TNFα was the physiologically active molecule. Certolizumab pegol was shown to neutralize membrane-associated and soluble human TNFα in a dose-dependent manner.
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 · UMD07X179E · 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 122 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.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
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
Fertility and sexual health
∅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.
∅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
Fertility and sexual health
sperm morphology
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.
— Not recorded
Harms were not a registered measure for this goal.
… Waiting for a reviewer
Who was studied is listed further down the page.
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.
American College of Rheumatology 20% (ACR20) Response at Week 12
✗ The study did not show it
Who was studied
NCT00717236
How many people
1648
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
To assess the efficacy of CDP870 in combination with Methotrexate in the treatment of Rheumatoid Arthritis and prevention of structural damage by measuring the ACR20 response at week 24 and change from Baseline
✗ The study did not show it
Who was studied
NCT00152386
How many people
950
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 Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 12
✗ The study did not show it
Who was studied
NCT01500278
How many people
915
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
Percentage of Subjects in Sustained Remission at Week 52
✗ The study did not show it
Who was studied
NCT01519791
How many people
880
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 Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years
✗ The study did not show it
Who was studied
NCT00175877
How many people
857
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
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
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.6 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 lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.1 registered measure of this kind.
■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.
No registered study measured anything of this kind.
Measured
Things only a test, a scale or a device shows.
maximum plasma concentration
Meaningful
Things that change how a life goes, not only a number.
remission at week 24 from baseline according to cdai
remission at week 24 after dose reduction according to cdai
in sustained remission at week 52
pd signals predict relapse at week 16
who achieve clinical remission using das28 crp
maintaining remission after biologic treatment withdrawal
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)
clinical response at week 6
american college of rheumatology 20 response at week 12
adverse events
crohn s disease activity index
mucosal healing
sperm morphology
disease activity
modified total sharp at week 52
who had a disease activity 28 3 2 at week 104
response rate
clinical recurrence rates of crohn s disease
surgical site infection
at least one treatment emergent adverse event
at least one treatment emergent serious adverse event
mechanistic comparisons
incidence of adverse events
2 in das28
maintaining low disease activity after dose reduction
eular response criteria
good eular
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 take◇Read 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.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
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.
How fast the body clears it. 14 days
Read from the label, which states: “The terminal elimination phase half-life (t 1/2 ) was approximately 14 days for all doses tested.”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
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 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.
CIMZIA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy ( 1.1 ) Treatment of adults with moderately to severely active rheumatoid arthritis ( 1.2 ) Treatment of active polyarticular juvenile idiopathic…
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 for CIMZIA in pediatric patients less than 2 years of age with pJIA have not been established.”
US prescribing information · b4c2c9dc-a0bb-4d64-a667-a67ebe88392d · read 2026-08-30
On older people, the label states: “Clinical studies of CIMZIA did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects.”
US prescribing information · b4c2c9dc-a0bb-4d64-a667-a67ebe88392d · read 2026-08-30
On people who are pregnant, the label states: “Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to CIMZIA during pregnancy.”
US prescribing information · b4c2c9dc-a0bb-4d64-a667-a67ebe88392d · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary In a multicenter clinical study of 17 lactating women treated with CIMZIA at 200 mg every 2 weeks or 400 mg every 4 weeks, minimal certolizumab pegol concentrations were observed in breast milk.”
US prescribing information · b4c2c9dc-a0bb-4d64-a667-a67ebe88392d · 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
Prescription only
❝ 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, given by the injection, subcutaneous 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.
Certolizumab pegol appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 33240 reaction mentions were counted. One report can name several reactions.
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
6 products list this as an active ingredient in the United States drug directory. 6 of them contain it and nothing else.
FDA National Drug Code directory · 28877-7100 · read 2026-08-29
They are sold as injection, powder, lyophilized, for solution, injection, solution and solution, taken subcutaneous.
FDA National Drug Code directory · 28877-7100 · 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 · 28877-7100 · read 2026-08-29
1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · b4c2c9dc-a0bb-4d64-a667-a67ebe88392d · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · b4c2c9dc-a0bb-4d64-a667-a67ebe88392d · read 2026-08-29
Cimzia is subcutaneous at 3 DOSAGE FORMS AND STRENGTHS For injection: 200 mg lyophilized powder in a single-dose vial ( 3 ) Injection: 200 mg/mL solution in a single-dose prefilled syringe ( 3 ) For Injection: 200 mg of white to off-white lyophi…, recorded as fda label in effect 2026-02-24 in the United States.
US prescribing information · b4c2c9dc-a0bb-4d64-a667-a67ebe88392d · 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 Certolizumab pegol 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 Certolizumab pegol 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)
UMD07X179E
RxNorm concept
795081
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
1 approved application covers products containing this substance. The earliest was BLA125160, approved 20080422 to UCB INC.
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What is not here
5 questions this page could not answer
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The path through the body — found nothing in the sources checked.
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Recorded evidence blocks (10)
Q2
What did Certolizumab pegol's largest trial (105711 people) and its longest (32 years) measure?
105711 people in Certolizumab pegol's largest registered study, 32 years in its longest registered window, measuring Area under the plasma drug concentration-time curve from time 0 to infinity (AUC). ClinicalTrials.gov · 2026-09-01
58 phase3, 18 phase4, 16 phase2, 14 na or unstated, 7 phase1, 2 na; NCT04725422; 2050-08; no ageing endpoint recorded. Last human test completed 2026, NCT04123795.
Interpretation These counts include studies where Certolizumab pegol 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
58
phase4
18
phase2
16
na or unstated
14
phase1
7
na
2
1 more recorded row
Last recorded human testNCT04123795
2026-07-23
recorded 2026-09-01 · last checked 2026-09-04
Q3
Certolizumab pegol was tested only in human — what did it show?
safety (2), accrual/recruitment (5), sponsor decision unspecified (1) and other (2): Certolizumab pegol's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"Study was terminated early because of slow recruitment"; 10 of 113 registered studies
Show the evidence
Trial
NCT00307931
terminated; "Study was terminated early because of slow recruitment"
NCT00349752
terminated; "Recruitment was stopped early due to slow enrolment of this population. With no safety concerns, the study continued normally for subjects already recruited"
NCT00899678
terminated; "higher than projected discontinuation rate during Maintenance Phase"
NCT01292265
terminated; "Termination of study due to low enrollment. There were no safety issues."
NCT01582568
terminated; "Not enough subjects to reach accrual goals."
NCT01602302
terminated; "low recruitment"
4 further recorded trials
NCT01696942
terminated; "Lack of accrual"
NCT02353780
terminated; "Low enrollment"
NCT03100253
terminated; "Slow recrutiment"
NCT04643483
withdrawn; "Sponsor decision"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Certolizumab pegol used certolizumab pegol 400 mg — over how long?
8 recorded entries; human; also "certolizumab pegol 400 mg", "CDP870 400mg", "CDP870 200mg"
Show the evidence
human
NCT00349752
certolizumab pegol 400 mg
NCT00791999
CDP870 400mg
NCT00791999
CDP870 200mg
NCT00791999
CDP870 100mg
NCT01147341
1 ml liquid product containing 200mg of Certolizumab Pegol
NCT01235598
Certolizumab Pegol (CZP) 200 mg
2 more recorded rows
humanNCT01235598
Certolizumab Pegol (CZP) 400 mg
humanNCT02451748
Certolizumab pegol (CDP870, tradename Cimzia)(prefilled syringes at the dose of 200mg)
recorded 2026-09-01 · last checked 2026-09-04
Q6
Certolizumab pegol's half-life is 14 days — which schedules were studied?
14 days, the half-life Certolizumab pegol's label states. openfda-label · b4c2c9dc-a0bb-4d64-a667-a67ebe88392d · 2026-08-30
bioavailability 80% %.
Show the evidence
half life
14 days; The terminal elimination phase half-life (t 1/2 ) was approximately 14 days for all doses tested.
bioavailability
80% %; Certolizumab pegol has bioavailability (F) of approximately 80% (ranging from 76% to 88%) following subcutaneous administration compared to intravenous administration.
metabolism
Metabolism The metabolism of certolizumab pegol has not been studied in human subjects.
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of 2 in das28, adverse events and adverse events during the study conduct did Certolizumab pegol's trials measure?
2 in das28, adverse events and adverse events during the study conduct lead 40 outcome terms across Certolizumab pegol's trials. ClinicalTrials.gov · 2026-09-01
adverse events, crohn s disease activity index, mucosal healing, sperm morphology, disease activity and modified total sharp at week 52 follow.
Show the evidence
clinical response at week 6
1
american college of rheumatology 20 response at week 12
1
maximum plasma concentration
1
adverse events
1
crohn s disease activity index
1
mucosal healing
1
14 more recorded rows
sperm morphology
1
disease activity
1
modified total sharp at week 52
1
remission at week 24 from baseline according to cdai
1
remission at week 24 after dose reduction according to cdai
1
who had a disease activity 28 3 2 at week 104
1
in sustained remission at week 52
1
response rate
1
pd signals predict relapse at week 16
1
clinical recurrence rates of crohn s disease
1
surgical site infection
1
at least one treatment emergent adverse event
1
at least one treatment emergent serious adverse event
1
mechanistic comparisons
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Certolizumab pegol's 6 ongoing trials reports first?
Fetal death and/or preterm delivery (<34 weeks) due to PE or PI in women with APS and LAC; Efficacy of Disease-modifying Antirheumatic Drugs Therapy for Rheumatoid Arthritis; latest 2050-08
Show the evidence
Trial
NCT03152058
"IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy"; n 55; "Fetal death and/or preterm delivery (<34 weeks) due to PE or PI in women with APS and LAC"; 2027-12
NCT03414502
"Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response"; n 400; "Efficacy of Disease-modifying Antirheumatic Drugs Therapy for Rheumatoid Arthritis"; 2029-03
NCT04725422
"CHronic Nonbacterial Osteomyelitis International Registry"; n 2000; "The change of CNO disease activity score"; 2050-08
NCT07138898
"Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty"; n 80; "Incidence of wound complications"; 2028-01
NCT07491913
"Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission"; n 40; "Proportion of Patients Maintaining Remission After Biologic Treatment Withdrawal"; 2027-12-15
NCT07644117
"Individualizing Anti-TNF Therapy in Patients With Inflammatory Bowel Disease"; n 40; "Rates of clinical response in UC patients"; 2028-12
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which 24 trials of Certolizumab pegol posted no result?
Posted no result
24 of 24 completed trials
Registrations
NCT00544154, NCT00548834, NCT00152425, NCT00152490, NCT00160602 and NCT00152386, and 18 more
Completion dates
oldest 2004-01; newest 2022-12-02
Show the evidence
Trial
NCT00544154
2004-01
NCT00548834
2004-07
NCT00152425
2005-05
NCT00152490
2005-05
NCT00160602
2006-09
NCT00152386
2006-10
14 further recorded trials
NCT00813774
2008-07
NCT01091220
2011-03
NCT01213017
2012-04
NCT02586246
2013-05
NCT01053559
2013-09
NCT02365948
2015-08
NCT01295151
2015-11
NCT01197066
2016-11
NCT02430909
2017-04
NCT02620189
2017-05-24
NCT02293590
2018-01-15
NCT01773681
2018-03
NCT01864265
2020-01-10
NCT03955861
2021-07-17
Q10
At the median, Certolizumab pegol's trials enrolled 132 people — anything larger?
Median enrolment
132
Largest enrolment
105711
Registered trials counted
111
Q11
What do 33240 spontaneous reports say about Certolizumab pegol — 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.
Certolizumab pegol appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 33240 reaction mentions were counted: rheumatoid arthritis 4982; pain 4618; fatigue 3730; rash 3432. open-targets-adr · CHEMBL1201831 · 2026-06-24
Show the evidence
rheumatoid arthritis
4982
pain
4618
fatigue
3730
rash
3432
alopecia
2884
joint swelling
2848
4 more recorded rows
drug intolerance
2817
abdominal discomfort
2786
arthralgia
2581
systemic lupus erythematosus
2562
recorded 2026-06-24 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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
✗ 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: 8 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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