Clinical trial NCT02087904: A Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis
Official title: A Phase 2a Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Knee Osteoarthritis
Medial Compartment Knee Osteoarthritis
Keywords: Osteoarthritis
Synovitis
Knee
Pain
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-03-14
Enrollment: 350
Sex: ALL
Minimum age (years): 35
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: 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
measure: Change From Baseline in Quantitative Synovitis of the Index Knee at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Effusion Volume of the Index Knee at Week 26
timeFrame: Baseline, Week 26
measure: 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
Secondary outcomes:
measure: Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Global Total Bone Marrow Lesion (BML) Score of the Index Knee Magnetic Resonance Imaging (MRI) at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Global Total BML Score of the Index Knee MRI at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Index Knee Intermittent and Constant Osteoarthritis Pain (ICOAP) Scores at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Index Knee ICOAP Scores at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Index Knee ICOAP Scores at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline In Index Knee Pain Intensity at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline In Index Knee Pain Intensity at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline In Index Knee Pain Intensity at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Patient Global Assessment (PGA) of Arthritis of the Index Knee at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in PGA of Arthritis of the Index Knee at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in PGA of Arthritis of the Index Knee at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Cartilage Volume of the Index Knee at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Cartilage Volume of the Index Knee at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Cartilage Thickness of the Index Knee at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Cartilage Thickness of the Index Knee at Week 52
timeFrame: Baseline, Week 52
measure: Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 16
timeFrame: Week 16
measure: Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 26
timeFrame: Week 26
measure: Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 52
timeFrame: Week 52
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Marc Levesque, MD
role: STUDY_CHAIR
References:
citation: Fleischmann RM, Bliddal H, Blanco FJ, Schnitzer TJ, Peterfy C, Chen S, Wang L, Feng S, Conaghan PG, Berenbaum F, Pelletier JP, Martel-Pelletier J, Vaeterlein O, Kaeley GS, Liu W, Kosloski MP, Levy G, Zhang L, Medema JK, Levesque MC. A Phase II Trial of Lutikizumab, an Anti-Interleukin-1alpha/beta Dual Variable Domain Immunoglobulin, in Knee Osteoarthritis Patients With Synovitis. Arthritis Rheumatol. 2019 Jul;71(7):1056-1069. doi: 10.1002/art.40840. Epub 2019 Jun 7.