Addition of Belimumab to B-cell Depletion in Relapsing-remitting Multiple Sclerosis
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (453 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2022-05-10, after 2021-10-01 start.
Reason given by the sponsor: “business”
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 2022-05-10. 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: celltherapymalignancydiseaseevidence of
Phrases that lowered it: vaccineparticipantsthe investigatorsinglethe study -
Sponsor's past termination rate: 15.1% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 51.5% (lowers risk) · Drug's FDA history
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Phase: 2 (raises risk) · Design
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Design: parallel (raises risk) · Design
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Sponsor's past trials: 754 (raises risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 155 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 3.0% (lowers risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (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
- academic or other
- Sponsor's past trials
- 754 (typical: 32)
- Sponsor's past termination rate
- 15.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 155 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 38320 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 9266 (typical: 412.5)
- Drug's FAERS reports marked serious
- 51.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 3.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, immunology
- Drugs matched to FDA substances
- belimumab, ocrelizumab
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
- Ofatumumab Subcutaneous Administration in Subjects With Relapsing-Remitting Multiple Sclerosis NCT01457924 · started 2011 · scored riskier than 52% of active trials completed
- Investigating Mechanism of Action of DAC HYP in the Treatment of High-Inflammatory Multiple Sclerosis (MS) NCT01143441 · started 2010 · scored riskier than 33% of active trials completed
- A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE NCT03312907 · started 2018 · scored riskier than 80% of active trials completed
- 9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis NCT04510220 · started 2020 · scored riskier than 86% of active trials completed
- Natalizumab (BG00002, Tysabri) Study in Japanese Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) NCT01440101 · started 2010 · scored riskier than 71% 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.