Efficacy and Safety Study of KN019 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
Model scores of the 29,894 trials active now.
Model score 10% 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 16% of the time (369 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-07-28, after 2019-11-08 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 2022-07-28. 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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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: patientkeyphase iistabledefined
Phrases that lowered it: arthritisthe efficacyand safetyto evaluateevaluate the -
Phase: 2 (raises risk) · Design
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Has a data monitoring committee: not given (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 6.7% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Blinding: quadruple (lowers risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports marked serious: 64.9% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Disease area, dermatology: Yes (raises risk) · Disease area
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Responsible party: sponsor (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
- quadruple (typical: none)
- Has a data monitoring committee
- not given (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 8 (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
- 295851 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 47036 (typical: 412.5)
- Drug's FAERS reports marked serious
- 64.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- immunology, dermatology, musculoskeletal
- Drugs matched to FDA substances
- methotrexate
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 Dose Range Finding Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis in Spite of Treatment With Methotrexate NCT01679951 · started 2012 · scored riskier than 54% of active trials terminated
- A Study to Evaluate the Safety and Efficacy of SM03 in Patients With Rheumatoid Arthritis Receiving Methotrexate NCT04192617 · started 2014 · scored riskier than 19% of active trials completed
- Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis NCT00959036 · started 2009 · scored riskier than 16% of active trials completed
- Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid Arthritis NCT01567358 · started 2012 · scored riskier than 11% of active trials completed
- A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate NCT03257852 · started 2017 · scored riskier than 11% 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.