Phase 2
Completed N=350
A Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis
Knee Osteoarthritis · Medial Compartment Knee Osteoarthritis
Source: ClinicalTrials.gov NCT02087904 ↗
Enrolled (actual)
350
Serious AEs
8.9%
Results posted
Aug 2019
Primary outcomePrimary: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16 — -8.9; -9.2; -11.8; -10.1 score on a scale — p=0.834
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16 |
-8.9; -9.2; -11.8; -10.1 | 0.834 |
| PRIMARY Change From Baseline in Quantitative Synovitis of the Index Knee at Week 26 |
-0.05; 0.01; -0.08; 0.01 | 0.145 |
| PRIMARY Change From Baseline in Effusion Volume of the Index Knee at Week 26 |
0.03; 0.26; -1.04; -1.49 | 0.897 |
| PRIMARY Change From Baseline in Whole-Organ Magnetic Resonance Imaging Score (WORMS) Semi-Quantitative Synovitis/Effusion Score of the Index Knee at Week 26 |
0.07; -0.01; -0.08; -0.07 | 0.384 |
| SECONDARY Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 16 |
-28.7; -29.8; -36.3; -32.1 | 0.818 |
| SECONDARY Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 26 |
-29.7; -31.8; -38.9; -36.9 | 0.666 |
| SECONDARY Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 52 |
-32.9; -36.1; -38.7; -39.7 | 0.558 |
| SECONDARY Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 26 |
-9.2; -9.8; -11.9; -11.6 | 0.664 |
| SECONDARY Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 52 |
-10.0; -11.0; -12.1; -12.2 | 0.5 |
| SECONDARY Change From Baseline in Global Total Bone Marrow Lesion (BML) Score of the Index Knee Magnetic Resonance Imaging (MRI) at Week 26 |
0.1; 0.3; -0.0; 0.1 | 0.319 |
| SECONDARY Change From Baseline in Global Total BML Score of the Index Knee MRI at Week 52 |
0.1; 0.2; 0.1; 0.0 | 0.602 |
| SECONDARY Change From Baseline in Index Knee Intermittent and Constant Osteoarthritis Pain (ICOAP) Scores at Week 16 |
-20.2; -19.5; -21.3; -18.8; -18.6; -17.7 | 0.804 |
| SECONDARY Change From Baseline in Index Knee ICOAP Scores at Week 26 |
-18.7; -19.7; -21.3; -21.7; -19.6; -18.8 | 0.75 |
| SECONDARY Change From Baseline in Index Knee ICOAP Scores at Week 52 |
-23.2; -25.4; -23.6; -27.2; -20.6; -21.8 | 0.545 |
| SECONDARY Change From Baseline In Index Knee Pain Intensity at Week 16 |
-2.4; -2.4; -2.7; -2.1; -2.3; -2.4 | 0.874 |
| SECONDARY Change From Baseline In Index Knee Pain Intensity at Week 26 |
-2.2; -2.4; -2.8; -2.5; -2.5; -2.5 | 0.661 |
| SECONDARY Change From Baseline In Index Knee Pain Intensity at Week 52 |
-2.9; -2.9; -2.9; -3.1; -2.8; -3.0 | 0.978 |
| SECONDARY Change From Baseline in Patient Global Assessment (PGA) of Arthritis of the Index Knee at Week 16 |
-2.5; -2.4; -2.9; -2.6 | 0.728 |
| SECONDARY Change From Baseline in PGA of Arthritis of the Index Knee at Week 26 |
-2.4; -2.4; -3.0; -2.7 | 0.984 |
| SECONDARY Change From Baseline in PGA of Arthritis of the Index Knee at Week 52 |
-3.0; -2.9; -3.2; -3.5 | 0.836 |
| SECONDARY Change From Baseline in Cartilage Volume of the Index Knee at Week 26 |
-326.0; -325.5; -322.4; -359.0; -59.1; -54.9 | 0.992 |
| SECONDARY Change From Baseline in Cartilage Volume of the Index Knee at Week 52 |
-557.0; -598.7; -554.3; -583.1; -101.2; -126.3 | 0.554 |
| SECONDARY Change From Baseline in Cartilage Thickness of the Index Knee at Week 26 |
-0.047; -0.047; -0.048; -0.052; -0.085; -0.077 | 0.972 |
| SECONDARY Change From Baseline in Cartilage Thickness of the Index Knee at Week 52 |
-0.081; -0.085; -0.081; -0.083; -0.136; -0.176 | 0.619 |
| SECONDARY Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 16 |
60.0; 67.0; 72.6; 65.5 | 0.311 |
| SECONDARY Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 26 |
62.4; 64.8; 66.7; 72.7 | 0.744 |
| SECONDARY Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 52 |
70.6; 69.3; 71.4; 72.7 | 0.824 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02087904). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.