Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis
Model scores of the 29,894 trials active now.
Model score 10% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 17% of the time (213 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2025-04-08, after 2015-11-26 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2025-04-08. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: subjects withsubjectterm safetylongcompleted
Phrases that lowered it: colitisto evaluateefficacyadalimumabopen -
Drug's FAERS reports marked serious: 40.5% (lowers risk) · Drug's FDA history
-
Drug's FAERS reports with a death: 3.2% (lowers risk) · Drug's FDA history
-
Sponsor's past termination rate: 4.5% (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 97 (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
-
Disease area, neurology: No (lowers risk) · Disease area
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Maximum age: 17 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 44 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports before start: 61713 (lowers risk) · Drug's FDA history
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Number of arms: 1 (raises risk) · Design
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 3 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 4 (typical: 18)
- Maximum age
- 17 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 44 (typical: 32)
- Sponsor's past termination rate
- 4.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 97 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 61713 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 52769 (typical: 412.5)
- Drug's FAERS reports marked serious
- 40.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 3.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive
- Drugs matched to FDA substances
- adalimumab
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis NCT02065557 · started 2014 · scored riskier than 21% of active trials completed
- Open Label Study to Evaluate Long Term Efficacy, Safety and Tolerability of Repeated Dosing in Subjects With Crohn's Disease and Who Participated and Successfully Completed M14-115 NCT02185014 · started 2014 · scored riskier than 25% of active trials completed
- Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806 NCT00686374 · started 2008 · scored riskier than 25% of active trials completed
- Long-Term Safety Of PF-00547659 In Ulcerative Colitis NCT01771809 · started 2013 · scored riskier than 86% of active trials completed
- Pharmacokinetics of Adalimumab With Methotrexate for Treatment of Patients With Ulcerative Colitis (UC) NCT01716039 · started 2013 · scored riskier than 65% of active trials terminated
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.