Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis
Model scores of the 29,894 trials active now.
Model score 29% 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 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
Completed on 2023-09-06, after 2010-05-12 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 2023-09-06. 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: extensionlong termterm safetythe longcompleted
Phrases that lowered it: investigate theefficacyoralto investigatemultiple -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 20% (raises risk) · Sponsor's track record
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Disease area, neurology: Yes (raises risk) · Disease area
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Phase: 2 (raises risk) · Design
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Blinding: quadruple (lowers risk) · Design
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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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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Number of arms: 3 (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 14 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 25 (lowers risk) · Sponsor's track record
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Drug's FAERS reports before start: 0 (raises risk) · Drug's FDA history
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Responsible party: sponsor (lowers 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
- 2
- Number of arms
- 3 (typical: 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
- 18
- Maximum age
- 55 (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
- 25 (typical: 32)
- Sponsor's past termination rate
- 20% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 14 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, immunology
- Drugs matched to FDA substances
- ponesimod
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
- Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis NCT03232073 · started 2017 · scored riskier than 98% of active trials completed
- Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients NCT01628393 · started 2012 · scored riskier than 82% of active trials completed
- Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis NCT02425644 · started 2015 · scored riskier than 42% of active trials completed
- A Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis NCT01318421 · started 2010 · scored riskier than 84% of active trials terminated
- Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis NCT02047734 · started 2013 · scored riskier than 16% 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.