CompletedPhase 2

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

350 participantsStarted 2014-06-04

Plain-language summary

A Phase 2a, multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the safety, tolerability, efficacy and pharmacokinetic/pharmacodynamic effect of ABT-981 in patients with symptomatic, radiographic, and inflammatory knee osteoarthritis.

Who can participate

Age range35 Years – 74 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Radiographic knee osteoarthritis with Kellgren-Lawrence Grade 2 or 3
✓. Body Mass Index (BMI) 18-34 kg/m2
✓. One or more clinical signs and symptoms of active inflammation in the index knee

Exclusion criteria

✕. History of allergic reaction to any constituents of the study drug, or to any Immunoglobulin G (IgG)-containing product
✕. History of anaphylactic reaction to any agent
✕. Significant trauma or surgery to the index knee
✕. Severe knee malalignment
✕. Any uncontrolled medical illness or an unstable treatment or therapy

What they're measuring

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16

Timeframe: Baseline, Week 16

Change From Baseline in Quantitative Synovitis of the Index Knee at Week 26

Timeframe: Baseline, Week 26

Change From Baseline in Effusion Volume of the Index Knee at Week 26

Timeframe: Baseline, Week 26

Change From Baseline in Whole-Organ Magnetic Resonance Imaging Score (WORMS) Semi-Quantitative Synovitis/Effusion Score of the Index Knee at Week 26

Timeframe: Baseline, Week 26

Trial details

NCT IDNCT02087904

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-06-07

Results submitted2019-07-15

View on ClinicalTrials.gov More Knee Osteoarthritis trials