A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment

NCT00810199 on ClinicalTrials.gov Phase 3 Hoffmann-La Roche (industry) Started 2009-03-31 Completed

Riskier than 13% of active trials

Model scores of the 29,894 trials active now.

Model score 9% 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 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 2013-01-31, after 2009-03-31 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 2013-01-31. 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

Phase: 3 (lowers risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Drug's FAERS reports marked serious: 59.8% (lowers risk) · Drug's FDA history
Drug's FAERS reports with a death: 10.5% (lowers risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Has a data monitoring committee: not given (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Design: parallel (raises risk) · Design
Trials the sponsor started in the prior 2 years: 192 (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Disease area, dermatology: Yes (raises risk) · Disease area
Blinding: quadruple (lowers risk) · Design
Sponsor's past termination rate: 11.1% (raises risk) · Sponsor's track record
Maximum age: not given (raises 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: 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: 198 (typical: 32)
Sponsor's past termination rate: 11.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 192 (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: 34829 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 9370 (typical: 412.5)
Drug's FAERS reports marked serious: 59.8% (typical: 85.6%)
Drug's FAERS reports with a death: 10.5% (typical: 15.9%)

Disease area and drugs

Disease areas: immunology, dermatology, musculoskeletal
Drugs matched to FDA substances: methotrexate, tocilizumab

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 of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis. NCT00773461 · started 2008 · scored riskier than 10% of active trials completed
A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis NCT01007435 · started 2009 · scored riskier than 23% of active trials completed
A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid Arthritis NCT01194414 · started 2010 · scored riskier than 12% of active trials completed
A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis NCT01232569 · started 2011 · scored riskier than 16% of active trials completed
A Study to Assess Efficacy With Respect to Clinical Improvement in Disease Activity and Safety of Tocilizumab in Patients Wtih Active Rheumatoid Arthritis. NCT00754559 · started 2008 · 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.