A Phase III Study Evaluate the Efficacy and Safety of BAT1406 and Humira
Model scores of the 29,894 trials active now.
Model score 15% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 12% of the time (114 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-05-31, after 2016-12-13 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 2018-05-31. 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) (raises risk) · Wording
Phrases that raised it: ulncellcountcarcinomaheart
Phrases that lowered it: screeningthe trialsubjectsperioddiseases -
Accepts healthy volunteers: No (raises risk) · Who can join
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Drug's FAERS reports marked serious: 34.2% (lowers risk) · Drug's FDA history
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Phase: 3 (lowers risk) · Design
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 2.4% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Blinding: quadruple (lowers risk) · Design
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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
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Minimum age: 16 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 84621 (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 148037 (lowers risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Number of arms: 2 (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
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 16 (typical: 18)
- Maximum age
- 65 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (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
- 148037 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 84621 (typical: 412.5)
- Drug's FAERS reports marked serious
- 34.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- musculoskeletal
- 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
- Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection in the Treatment of Moderate-to-Severe Active AS NCT07498634 · started 2023 · scored riskier than 55% of active trials completed
- Study of Safety and Efficacy of HLX01+MTX in Patients With Rheumatoid Arthritis NCT03522415 · started 2018 · scored riskier than 51% of active trials completed
- Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA NCT04156620 · started 2019 · scored riskier than 68% of active trials completed
- Phase II Study of Hemay005 in Patients With Active Ankylosing Spondylitis NCT05407246 · started 2022 · scored riskier than 59% of active trials completed
- Clinical Study of Single Dose IL-6R mAb Injection in RA Patients NCT05232396 · started 2021 · scored riskier than 29% 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.