A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids 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 (240 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 2013-01-29, after 2011-02-14 start.
Reason given by the sponsor: “efficacy”
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 2013-01-29. 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: metastaticpatientscellcarcinomaprior
Phrases that lowered it: opensinglelabelrandomizedprotein -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Has a data monitoring committee: not given (lowers risk) · Design
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Sponsor's past termination rate: 12.9% (raises risk) · Sponsor's track record
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Minimum age: 50 (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: 13.4% (lowers risk) · Drug's FDA history
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Blinding: double (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 275 (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 73.0% (lowers risk) · Drug's FDA history
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Number of arms: 3 (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports in the prior 12 months: 8544 (lowers risk) · Drug's FDA history
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Sponsor's past trials: 271 (lowers risk) · Sponsor's track record
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Disease area, dermatology: Yes (raises risk) · Disease area
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Maximum age: 85 (lowers risk) · Who can join
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Drugs with FDA adverse-event history: 2 (lowers risk) · Drug's FDA history
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Collaborators: 0 (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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 50 (typical: 18)
- Maximum age
- 85 (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
- 271 (typical: 32)
- Sponsor's past termination rate
- 12.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 275 (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
- 34725 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 8544 (typical: 412.5)
- Drug's FAERS reports marked serious
- 73.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 13.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- dermatology, musculoskeletal
- Drugs matched to FDA substances
- canakinumab, prednisone, secukinumab
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
- Delayed Release Prednisone in PMR NCT02702778 · started 2016 · scored riskier than 29% of active trials terminated
- Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica NCT03600818 · started 2018 · scored riskier than 50% of active trials terminated
- Study of Tocilizumab to Treat Polymyalgia Rheumatica NCT01396317 · started 2011 · scored riskier than 55% of active trials completed
- 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
- Induction and Tapering Therapy With Tofacitinib and Glucocorticoid in Patients With Polymyalgia Rheumatica NCT06172361 · started 2024 · scored riskier than 20% 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.