A Study of Tocilizumab (RoActemra/Actemra) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous Tumor Necrosis Factor (TNF) Antagonist Therapy

NCT01209689 on ClinicalTrials.gov Phase 3 Hoffmann-La Roche (industry) Started 2010-10-31 Terminated

Riskier than 28% of active trials

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 12% of the time (114 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

Terminated on 2011-12-31, after 2010-10-31 start.

Reason given by the sponsor: “efficacy”

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 2011-12-31. 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: kgplaceboscreeningdouble blindprior to
Phrases that lowered it: patientstumortherapyweeksmajor surgery
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Has a data monitoring committee: not given (lowers risk) · Design
Sponsor's past termination rate: 11.1% (raises risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Drug's FAERS reports with a death: 17.3% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 173 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Blinding: double (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Sponsor's past trials: 351 (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Keywords listed: 0 (lowers 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: 3 (typical: 2)
Number of arms: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: double (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: 351 (typical: 32)
Sponsor's past termination rate: 11.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 173 (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: 617 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 588 (typical: 412.5)
Drug's FAERS reports marked serious: 98.5% (typical: 85.6%)
Drug's FAERS reports with a death: 17.3% (typical: 15.9%)

Disease area and drugs

Disease areas: musculoskeletal
Drugs matched to FDA substances: 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 RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment With NSAIDs NCT01209702 · started 2010 · scored riskier than 17% of active trials terminated
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 Phase III Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis NCT06378697 · started 2023 · scored riskier than 23% of active trials completed
An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy. NCT00750880 · started 2008 · scored riskier than 7% of active trials completed
A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis NCT05467995 · started 2021 · scored riskier than 13% 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.