Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Non-ST Elevation Myocardial Infarction

NCT01491074 on ClinicalTrials.gov Phase 2 Oslo University Hospital (academic or other) Started 2011-08-31 Completed

Riskier than 55% of active trials

Model scores of the 29,894 trials active now.

Model score 17% for any early termination, 14% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (446 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 2014-04-30, after 2011-08-31 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 2014-04-30. 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: acuteplaceboconcurrentrandomized doublecontrolled study
Phrases that lowered it: receptorpatientstermconsent towith known
Sponsor's past termination rate: 4.3% (lowers risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Collaborators: 4 (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 56 (lowers risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Blinding: quadruple (lowers risk) · Design
Drug's FAERS reports with a death: 15.3% (lowers risk) · Drug's FDA history
Sponsor type: academic or other (raises risk) · Sponsor's track record
Has a data monitoring committee: Yes (raises risk) · Design
Phase: 2 (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports marked serious: 97.6% (raises risk) · Drug's FDA history
Number of arms: 2 (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Sponsor's past trials: 47 (lowers risk) · Sponsor's track record
Keywords listed: 0 (raises risk) · Design
Disease area, cardiovascular: Yes (raises 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: 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: 4 (typical: 0)
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 80 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 47 (typical: 32)
Sponsor's past termination rate: 4.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 56 (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: 1461 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 987 (typical: 412.5)
Drug's FAERS reports marked serious: 97.6% (typical: 85.6%)
Drug's FAERS reports with a death: 15.3% (typical: 15.9%)

Disease area and drugs

Disease areas: cardiovascular
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

ASSessing the Effect of Anti-IL-6 Treatment in Myocardial Infarction: The ASSAIL-MI Trial NCT03004703 · started 2017 · scored riskier than 69% of active trials completed
Controlled Level EVERolimus in Acute Coronary Syndromes NCT01529554 · started 2015 · scored riskier than 56% of active trials completed
Anakinra to Prevent Adverse Post-infarction Remodeling (2) NCT01175018 · started 2010 · scored riskier than 48% of active trials completed
Interleukin-1 (IL-1) Blockade in Acute Myocardial Infarction (VCU-ART3) NCT01950299 · started 2014 · scored riskier than 84% of active trials completed
Low-dose Interleukin-2 for the Reduction of Vascular Inflammation in Acute Coronary Syndromes - IVORY NCT04241601 · started 2020 · scored riskier than 86% 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.