An Open-label, Long-term Extension Study With Filgotinib in Active Psoriatic Arthritis.
Model scores of the 29,894 trials active now.
Model score 23% 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 in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2021-06-30, after 2017-07-26 start.
Reason given by the sponsor: “business”
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 2021-06-30. 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: subjectslong termextensionsubjectcompleted
Phrases that lowered it: arthritisjointvaluesaccordingefficacy -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 2.0% (lowers risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 26 (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor's past trials: 51 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Disease area, cancer: No (lowers risk) · Disease area
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Blinding: none (raises risk) · Design
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Number of arms: 1 (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Disease area, dermatology: Yes (raises risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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Collaborators: 0 (raises risk) · Design
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Drug's FAERS reports before start: 0 (raises risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 0 (raises 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
- 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
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 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
- 51 (typical: 32)
- Sponsor's past termination rate
- 2.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 26 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- dermatology, musculoskeletal
- Drugs matched to FDA substances
- filgotinib
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
- Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Participants NCT02065700 · started 2014 · scored riskier than 97% of active trials completed
- Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy NCT04115748 · started 2019 · scored riskier than 25% of active trials terminated
- A Study to Assess Efficacy and Safety of Filgotinib in Active Psoriatic Arthritis NCT03101670 · started 2017 · scored riskier than 31% of active trials completed
- Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis NCT03025308 · started 2017 · scored riskier than 87% of active trials completed
- Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Have an Inadequate Response or Are Intolerant to Biologic DMARD Therapy NCT04115839 · started 2019 · scored riskier than 41% 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.