Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission
Model scores of the 29,894 trials active now.
Model score 13% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 9% of the time (336 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2019-12-06, after 2015-02-20 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 2019-12-06. 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
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: subject hasmonths priorsclerosismay applycriteria may
Phrases that lowered it: participantsmonotherapyrheumatoidin periodday -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 43.9% (lowers risk) · Drug's FDA history
-
Phase: 3 (lowers risk) · Design
-
Drug's FAERS reports with a death: 5.0% (lowers risk) · Drug's FDA history
-
Sponsor's past termination rate: 9.0% (raises risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Blinding: quadruple (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 80 (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: No (lowers risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports before start: 453572 (lowers risk) · Drug's FDA history
-
Primary purpose: treatment (raises risk) · Design
-
Number of arms: 4 (lowers risk) · Design
-
Sponsor's past trials: 355 (lowers risk) · Sponsor's track record
-
Disease area, dermatology: Yes (raises risk) · Disease area
-
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
- 4 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: 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
- 355 (typical: 32)
- Sponsor's past termination rate
- 9.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 80 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 453572 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 79664 (typical: 412.5)
- Drug's FAERS reports marked serious
- 43.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- immunology, dermatology, musculoskeletal
- Drugs matched to FDA substances
- etanercept, folic acid, 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
- Study to Investigate the Safety and Efficacy of Tregalizumab in Subjects (MTX-IR) With Active Rheumatoid Arthritis NCT01999192 · started 2013 · scored riskier than 18% of active trials terminated
- Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis NCT02376790 · started 2015 · scored riskier than 23% of active trials completed
- A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate NCT00965757 · started 2009 · scored riskier than 15% of active trials completed
- Study Comparing Etanercept (ETN) Against a Placebo for Etanercept on a Background Nonsteroidal Anti Inflammatory Drug (NSAIDs) in the Treatment of Early Spondyloarthritis (SpA) Patients Who do Not Have X-ray Structural Changes NCT01258738 · started 2011 · scored riskier than 75% of active trials completed
- A Clinical Trial to Study the Effects of Revamilast in Patients With Rheumatoid Arthritis NCT01430507 · started 2011 · scored riskier than 51% 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.