Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 6% of the time (238 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2021-05-19, after 2018-10-09 start.
Reason given by the sponsor: “enrollment”
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 2021-05-19. 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: placeboscreeninghistory ofto assessassess the
Phrases that lowered it: participantswith historypatients withtumorparticipant -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 11.0% (lowers risk) · Drug's FDA history
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Sponsor's past trials: 928 (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Sponsor's past termination rate: 10.3% (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 73 (lowers risk) · Sponsor's track record
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Minimum age: 50 (raises risk) · Who can join
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports before start: 202065 (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, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Drug's FAERS reports marked serious: 72.4% (lowers risk) · Drug's FDA history
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Disease area, dermatology: Yes (raises risk) · Disease area
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Drug's FAERS reports in the prior 12 months: 35762 (lowers risk) · Drug's FDA history
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
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 50 (typical: 18)
- Maximum age
- not given (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
- 928 (typical: 32)
- Sponsor's past termination rate
- 10.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 73 (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
- 202065 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 35762 (typical: 412.5)
- Drug's FAERS reports marked serious
- 72.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- dermatology, musculoskeletal
- Drugs matched to FDA substances
- prednisone, sarilumab
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
- Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR) NCT05767034 · started 2023 · scored riskier than 46% of active trials completed
- A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis NCT06073093 · started 2023 · scored riskier than 80% of active trials completed
- Delayed Release Prednisone in PMR NCT02702778 · started 2016 · scored riskier than 29% of active trials terminated
- A Study to Evaluate the Efficacy of Tocilizumab as a Remission-Induction and Glucocorticoid-Sparing Regimen in Subjects With New-Onset Polymyalgia Rheumatica (PMR- SPARE) NCT03263715 · started 2017 · scored riskier than 72% of active trials completed
- A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica NCT01364389 · started 2011 · scored riskier than 47% 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.