Efficacy and Safety of Ofatumumab in Treatment of Pemphigus Vulgaris
Model scores of the 29,894 trials active now.
Model score 23% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 9% of the time (336 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 2018-01-11, after 2013-08-13 start.
Reason given by the sponsor: “business”
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 2018-01-11. 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: subjectcellsubjects withremissionantibody
Phrases that lowered it: and safetysafety ofthe efficacyefficacy andevidence or -
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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Sponsor's past trials: 548 (raises risk) · Sponsor's track record
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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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Trials the sponsor started in the prior 2 years: 305 (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
-
Design: parallel (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Blinding: double (raises risk) · Design
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Drug's FAERS reports with a death: 14.4% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
-
Number of arms: 2 (raises risk) · Design
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Disease area, dermatology: Yes (raises risk) · Disease area
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Drug's FAERS reports before start: 666 (raises risk) · Drug's FDA history
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Collaborators: 0 (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 266 (raises risk) · Drug's FDA history
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Keywords listed: 13 (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
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 13 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 70 (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
- 305 (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
- 666 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 266 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 14.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- immunology, dermatology
- 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
- A Study of PRN1008 in Adult Patients With Pemphigus Vulgaris NCT02704429 · started 2016 · scored riskier than 39% of active trials completed
- A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV) NCT02383589 · started 2015 · scored riskier than 28% of active trials completed
- Long-Term Extension Study of Ofatumumab in Subjects With Pemphigus Vulgaris NCT02613910 · started 2015 · scored riskier than 62% of active trials terminated
- A Study to Evaluate the Safety, PD, PK and Efficacy of ARGX-113 in Patients With Pemphigus NCT03334058 · started 2017 · scored riskier than 53% of active trials completed
- A Proof-of-Concept Study of Topical AC-203 in Patients With Bullous Pemphigoid NCT03286582 · started 2017 · scored riskier than 15% of active trials terminated
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.