A Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis

NCT02087904 on ClinicalTrials.gov Phase 2 AbbVie (industry) Started 2014-06-04 Completed

Riskier than 8% 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 13% of the time (103 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 2016-12-13, after 2014-06-04 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 2016-12-13. 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: abtillnessuncontrolledof allergiceffects
Phrases that lowered it: kneeefficacy andosteoarthritisparallelpharmacokinetic
Sponsor's past termination rate: 4.2% (lowers risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Maximum age: 74 (raises risk) · Who can join
Blinding: quadruple (lowers risk) · Design
Minimum age: 35 (lowers risk) · Who can join
Design: parallel (raises risk) · Design
Trials the sponsor started in the prior 2 years: 52 (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Number of arms: 4 (lowers risk) · Design
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Sponsor's past trials: 24 (lowers risk) · Sponsor's track record
Primary purpose: treatment (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: quadruple (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 4 (typical: 1)

Who can join

Minimum age: 35 (typical: 18)
Maximum age: 74 (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: 24 (typical: 32)
Sponsor's past termination rate: 4.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 52 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 0 (typical: 1)
Drug has FAERS history: No (typical: 64% yes)
Drug's FAERS reports before start: 0 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 0 (typical: 412.5)
Drug's FAERS reports marked serious: no FAERS history (typical: 85.6%)
Drug's FAERS reports with a death: no FAERS history (typical: 15.9%)

Disease area and drugs

Disease areas: musculoskeletal
Drugs matched to FDA substances: none matched

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 to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-981 in Patients With Osteoarthritis of the Knee NCT01668511 · started 2012 · scored riskier than 6% of active trials completed
A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee NCT01207115 · started 2010 · scored riskier than 6% of active trials completed
A Study of ABT-652 in Combination With a Nonsteroidal Anti-Inflammatory Drug (NSAID) in Adults With Osteoarthritis Pain of the Knee NCT01444365 · started 2011 · scored riskier than 10% of active trials completed
A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of LG00034053 in Patients With Knee OA NCT05237752 · started 2022 · scored riskier than 8% of active trials completed
A Phase 2a Study Evaluating the Safety and Efficacy of ABT-981 in Patients With Erosive Hand Osteoarthritis NCT02384538 · started 2015 · scored riskier than 21% 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.