A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
Model scores of the 29,894 trials active now.
Model score 14% 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 9% of the time (336 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 2015-10-31, after 2014-05-31 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 2015-10-31. 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: heartstablesubjectto screeningmyocardial
Phrases that lowered it: the efficacyevaluate theto evaluategrouppharmacokinetics -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Phase: 3 (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Blinding: quadruple (lowers risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Drug's FAERS reports with a death: 7.3% (lowers risk) · Drug's FDA history
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Maximum age: 75 (raises risk) · Who can join
-
Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports marked serious: 72.8% (lowers risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 6 (raises risk) · Sponsor's track record
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
- 1
Who can join
- Minimum age
- 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
- 3 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 6 (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
- 3366 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1997 (typical: 412.5)
- Drug's FAERS reports marked serious
- 72.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- immunology, dermatology, musculoskeletal
- Drugs matched to FDA substances
- adalimumab
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 Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy NCT01895309 · started 2013 · scored riskier than 13% of active trials completed
- A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy NCT01936181 · started 2013 · scored riskier than 13% of active trials completed
- MSB11022 in Moderate to Severe Rheumatoid Arthritis NCT03052322 · started 2017 · scored riskier than 11% of active trials completed
- A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy NCT02746380 · started 2016 · scored riskier than 5% of active trials completed
- A Study of JHL1101 Versus MabThera® in Subjects With Severe Rheumatoid Arthritis NCT03161457 · started 2017 · scored riskier than 28% of active trials terminated
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.