A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Model scores of the 29,894 trials active now.
Model score 19% 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 18% of the time (280 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-11-15, after 2018-11-20 start.
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 2021-11-15. 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: carcinomacelltherapymalignancyactive
Phrases that lowered it: evaluate theto evaluatescreeningparticipantsand safety -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Sponsor's past termination rate: 9.9% (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 2.3% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Trials the sponsor started in the prior 2 years: 114 (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
-
Number of arms: 3 (lowers risk) · Design
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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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Blinding: double (raises risk) · Design
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Sponsor's past trials: 362 (lowers risk) · Sponsor's track record
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Drug's FAERS reports in the prior 12 months: 7600 (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 68.2% (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
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 65 (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
- 362 (typical: 32)
- Sponsor's past termination rate
- 9.9%
- Trials the sponsor started in the prior 2 years
- 114 (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
- 25497 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 7600 (typical: 412.5)
- Drug's FAERS reports marked serious
- 68.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive
- Drugs matched to FDA substances
- golimumab, guselkumab
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 Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis. NCT01863771 · started 2013 · scored riskier than 40% of active trials completed
- Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis NCT02914522 · started 2016 · scored riskier than 56% of active trials completed
- A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis NCT01900574 · started 2013 · scored riskier than 24% of active trials completed
- A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis NCT02407236 · started 2015 · scored riskier than 49% of active trials completed
- A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease NCT04397263 · started 2020 · scored riskier than 16% 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.