A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)

NCT00642460 on ClinicalTrials.gov Phase 3 Hoffmann-La Roche (industry) Started 2008-05-31 Completed

Riskier than 9% of active trials

Model scores of the 29,894 trials active now.

Model score 7% 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 2014-08-31, after 2008-05-31 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 2014-08-31. 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) (lowers risk) · Wording Phrases that raised it: arthritisplacebojointsintravenouslong term
Phrases that lowered it: the effectevaluate theeffect oflabelopen
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Sponsor's past termination rate: 11.1% (raises risk) · Sponsor's track record
Drug's FAERS reports with a death: 11.1% (lowers risk) · Drug's FDA history
Drug's FAERS reports marked serious: 63.5% (lowers risk) · Drug's FDA history
Has a data monitoring committee: not given (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 181 (lowers risk) · Sponsor's track record
Minimum age: 2 (lowers risk) · Who can join
Design: parallel (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Blinding: quadruple (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports in the prior 12 months: 8520 (lowers risk) · Drug's FDA history
Sponsor's past trials: 144 (lowers risk) · Sponsor's track record
Disease area, dermatology: Yes (raises risk) · Disease area
Drug's FAERS reports before start: 26512 (lowers risk) · Drug's FDA history

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: 2 (typical: 18)
Maximum age: 17 (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: 144 (typical: 32)
Sponsor's past termination rate: 11.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 181 (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: 26512 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 8520 (typical: 412.5)
Drug's FAERS reports marked serious: 63.5% (typical: 85.6%)
Drug's FAERS reports with a death: 11.1% (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 Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis Who Completed WA19977 Core Study NCT01667471 · started 2012 · scored riskier than 23% of active trials completed
A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis From France Who Completed WA19977 Core Study NCT01673919 · started 2012 · scored riskier than 21% of active trials completed
An Extension Long-Term Study of RoActemra/Actemra (Tocilizumab) in Patients With Polyarticular Juvenile Idiopathic Arthritis Who Completed The WA19977 Study NCT01727986 · started 2013 · scored riskier than 28% of active trials completed
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNF NCT01326962 · started 2011 · scored riskier than 12% of active trials completed
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs (REMISSION) NCT01610791 · started 2010 · scored riskier than 8% 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.