A Study to Evaluate Efficacy and Safety of Infliximab in Participant With Moderate-to-Severe Refractory Intestinal Behcet's Disease
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (493 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-07-13, after 2015-07-22 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 2018-07-13. 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: least weeksstableintestinalbowelreceiving
Phrases that lowered it: participantparticipantsevaluateand safetyeffect of -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 3.0% (lowers risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
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Minimum age: 19 (lowers risk) · Who can join
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Design: single group (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 6.5% (lowers risk) · Drug's FDA history
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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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Primary purpose: treatment (raises risk) · Design
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Number of arms: 1 (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Maximum age: 75 (lowers risk) · Who can join
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
- 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
- 3 (typical: 1)
Who can join
- Minimum age
- 19 (typical: 18)
- Maximum age
- 75 (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
- 33 (typical: 32)
- Sponsor's past termination rate
- 3.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 75429 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 11807 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, dermatology
- Drugs matched to FDA substances
- infliximab
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
- Induction Therapy With Anti-TNFα vs Cyclophosphamide in Severe Behçet Disease NCT03371095 · started 2018 · scored riskier than 75% of active trials completed
- A Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease NCT01243671 · started 2010 · scored riskier than 8% of active trials completed
- Efficacy and Safety of Ustekinumab, a Human Monoclonal Anti-IL-12/IL-23 Antibody, in Patients With Behçet Disease NCT02648581 · started 2017 · scored riskier than 77% of active trials completed
- Efficacy of Humira in Behcet Patients With Arthritis NCT01497717 · started 2013 · scored riskier than 57% of active trials completed
- Low-dose IL-2 Treatment on Behcet's Disease NCT04065672 · started 2021 · scored riskier than 68% 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.