A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis
Model scores of the 29,894 trials active now.
Model score 16% 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 17% of the time (213 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
Completed on 2015-06-30, after 2012-06-30 start.
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 2015-06-30. 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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Sponsor's past termination rate: 16.2% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: subjects withintravenousischemicmonths priorinduction
Phrases that lowered it: moderateto severecp 690550colitis -
Accepts healthy volunteers: No (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 315 (raises risk) · Sponsor's track record
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Blinding: quadruple (lowers risk) · Design
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Phase: 3 (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Sponsor's past trials: 1120 (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
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Drug's FAERS reports with a death: 15.8% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 6 (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
- 1120 (typical: 32)
- Sponsor's past termination rate
- 16.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 315 (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
- 19 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 11 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 15.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive
- Drugs matched to FDA substances
- tofacitinib
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 Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis NCT01465763 · started 2012 · scored riskier than 45% of active trials completed
- A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis. NCT00787202 · started 2008 · scored riskier than 37% of active trials completed
- A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis NCT01458574 · started 2012 · scored riskier than 97% of active trials completed
- A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis NCT01620255 · started 2012 · scored riskier than 53% of active trials completed
- Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis NCT01470612 · started 2012 · scored riskier than 64% 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.