BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis
Model scores of the 29,894 trials active now.
Model score 30% 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 16% of the time (369 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 2016-01-31, after 2013-11-30 start.
Reason given by the sponsor: “other”
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 2016-01-31. 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: long termterm safetythe longplaceboextension
Phrases that lowered it: efficacy andevaluatesubjectsdiseasespregnant -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 19.9% (raises risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Minimum age: 19 (lowers risk) · Who can join
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 24.5% (raises risk) · Drug's FDA history
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Blinding: triple (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 41 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports before start: 18876 (lowers risk) · Drug's FDA history
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Sponsor's past trials: 146 (lowers risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 2948 (lowers risk) · Drug's FDA history
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Number of arms: 2 (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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Maximum age: 76 (raises risk) · Who can join
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
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 19 (typical: 18)
- Maximum age
- 76 (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
- 146 (typical: 32)
- Sponsor's past termination rate
- 19.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 41 (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
- 18876 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2948 (typical: 412.5)
- Drug's FAERS reports marked serious
- 97.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 24.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- immunology, dermatology, urogenital
- Drugs matched to FDA substances
- mycophenolate mofetil, mycophenolic acid
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
- BIIB023 Proof-of-Concept Study in Participants With Lupus Nephritis NCT01499355 · started 2012 · scored riskier than 94% of active trials terminated
- An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis NCT03385564 · started 2018 · scored riskier than 29% of active trials completed
- Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis NCT01714817 · started 2013 · scored riskier than 34% of active trials terminated
- Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis NCT02770170 · started 2016 · scored riskier than 39% of active trials completed
- Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus NCT03920267 · started 2019 · scored riskier than 99% 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.