9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis
Model scores of the 29,894 trials active now.
Model score 24% for any early termination, 10% 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 (741 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-12-28, after 2020-09-21 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 2022-12-28. 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: ventricularmricellfailurecardiac
Phrases that lowered it: effect ofthe effectaiminvestigatormultiple -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 11.5% (raises risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 81 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 95.7% (raises risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 16.9% (lowers risk) · Drug's FDA history
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Sponsor's past trials: 382 (lowers risk) · Sponsor's track record
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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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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Responsible party: principal investigator (lowers risk) · Design
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Drug's FAERS reports before start: 2523 (raises risk) · Drug's FDA history
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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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 60 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 382 (typical: 32)
- Sponsor's past termination rate
- 11.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 81 (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
- 2523 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 153 (typical: 412.5)
- Drug's FAERS reports marked serious
- 95.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 16.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- ofatumumab
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
- Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS NCT04788615 · started 2021 · scored riskier than 65% of active trials completed
- Addition of Belimumab to B-cell Depletion in Relapsing-remitting Multiple Sclerosis NCT04767698 · started 2021 · scored riskier than 60% of active trials terminated
- A First Time in Human Study Exploring Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK2618960 in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis (RRMS) NCT01808482 · started 2013 · scored riskier than 7% of active trials terminated
- Study to Assess Whether GSK239512 Can Remyelinate Lesions in Subjects With Relapsing Remitting Multiple Sclerosis NCT01772199 · started 2013 · scored riskier than 82% 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.