Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira
Model scores of the 29,894 trials active now.
Model score 5% 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 10% of the time (1,463 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2016-02-29, after 2013-12-31 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2016-02-29. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: chronicmay applycriteria maypatientsdefined
Phrases that lowered it: psoriasisplaquemoderateefficacy andto severe -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 2.6% (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Phase: 3 (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Design: parallel (raises risk) · Design
-
Blinding: quadruple (lowers risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 10.1% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 77 (lowers risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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Maximum age: not given (lowers risk) · Who can join
-
Number of arms: 2 (raises risk) · Design
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Collaborators: 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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (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
- 77 (typical: 32)
- Sponsor's past termination rate
- 2.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 9 (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
- 1844 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 622 (typical: 412.5)
- Drug's FAERS reports marked serious
- 85.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- 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
- MSB11022 in Moderate to Severe Chronic Plaque Psoriasis NCT02660580 · started 2016 · scored riskier than 4% of active trials completed
- Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis NCT02581345 · started 2015 · scored riskier than 10% of active trials completed
- Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA®) in Adults With Moderate to Severe Plaque Psoriasis NCT01970488 · started 2013 · scored riskier than 7% of active trials completed
- A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis NCT05073315 · started 2021 · scored riskier than 6% of active trials completed
- Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) and Enbrel NCT01891864 · started 2013 · scored riskier than 5% of active trials completed
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.