A Dose Range Finding Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis in Spite of Treatment With Methotrexate

NCT01679951 on ClinicalTrials.gov Phase 2 Janssen Research & Development, LLC (industry) Started 2012-10-31 Terminated

Riskier than 54% of active trials

Model scores of the 29,894 trials active now.

Model score 17% 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 16% of the time (369 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 2014-07-03, after 2012-10-31 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 2014-07-03. 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

Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 11.7% (raises risk) · Sponsor's track record
Phase: 2 (raises risk) · Design
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: purpose ofthe purposeof studystablejnj
Phrases that lowered it: diseasesarthritisthe informedrheumatoidadult
Design: parallel (raises risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Trials the sponsor started in the prior 2 years: 90 (lowers risk) · Sponsor's track record
Blinding: double (raises risk) · Design
Drug's FAERS reports marked serious: 62.1% (lowers risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports with a death: 9.7% (lowers risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Number of arms: 4 (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Collaborators: 0 (raises risk) · Design
Disease area, neurology: No (lowers 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: 4 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: double (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 5 (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: industry (typical: academic or other)
Sponsor's past trials: 60 (typical: 32)
Sponsor's past termination rate: 11.7% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 90 (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: 76212 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 15369 (typical: 412.5)
Drug's FAERS reports marked serious: 62.1% (typical: 85.6%)
Drug's FAERS reports with a death: 9.7% (typical: 15.9%)

Disease area and drugs

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

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

An Efficacy and Safety Study of JNJ-38518168 in Adult Participants With Rheumatoid Arthritis NCT00941707 · started 2010 · scored riskier than 28% of active trials terminated
A Study of JNJ-67484703 in Participants With Active Rheumatoid Arthritis NCT04985812 · started 2021 · scored riskier than 29% of active trials completed
A Synovial Biopsy Study of JNJ-38518168 in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy NCT01862224 · started 2013 · scored riskier than 75% of active trials terminated
A Study to Investigate How JNJ-38518168 May Affect the Plasma Levels of Methotrexate in Rheumatoid Arthritis Participants NCT01450982 · started 2011 · scored riskier than 12% of active trials completed
A Study of JNJ-40346527 in Patients With Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy NCT01597739 · started 2012 · scored riskier than 43% 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.