Safety and Efficacy of BAF312 in Dermatomyositis
Model scores of the 29,894 trials active now.
Model score 21% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 19% of the time (731 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
Terminated on 2016-02-17, after 2013-08-25 start.
Reason given by the sponsor: “efficacy”
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 2016-02-17. 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
-
Sponsor's past termination rate: 12.8% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: stableplacebosafety tolerabilityeyemonths
Phrases that lowered it: efficacy andand safetymgsafety ofthe efficacy -
Phase: 2 (raises risk) · Design
-
Sponsor's past trials: 548 (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 307 (raises risk) · Sponsor's track record
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Disease area, neurology: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
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Blinding: triple (raises risk) · Design
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Number of arms: 4 (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Collaborators: 0 (raises risk) · Design
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Drug's FAERS reports before start: 1 (raises risk) · Drug's FDA history
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Disease area, musculoskeletal: Yes (raises risk) · Disease area
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Disease area, dermatology: Yes (raises risk) · Disease area
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
- 2
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 18
- Maximum age
- 75 (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
- 548 (typical: 32)
- Sponsor's past termination rate
- 12.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 307 (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
- 1 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, dermatology, musculoskeletal
- Drugs matched to FDA substances
- siponimod
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 Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis NCT01148810 · started 2010 · scored riskier than 53% of active trials terminated
- Efficacy and Tolerability of BAF312 in Patients With Polymyositis NCT01801917 · started 2013 · scored riskier than 75% of active trials terminated
- A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis NCT05437263 · started 2022 · scored riskier than 30% of active trials completed
- Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis NCT02466243 · started 2015 · scored riskier than 25% of active trials terminated
- A Study In Adults With Moderate To Severe Dermatomyositis NCT03181893 · started 2018 · scored riskier than 95% 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.