A Phase 2a Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis
Status: | Completed |
---|---|
Conditions: | Arthritis, Osteoarthritis (OA) |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 35 - 74 |
Updated: | 12/21/2016 |
Start Date: | May 2014 |
End Date: | December 2016 |
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.
to evaluate the safety, tolerability, efficacy and pharmacokinetic/pharmacodynamic effect of
ABT-981 in patients with symptomatic, radiographic, and inflammatory knee osteoarthritis.
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
3. Severe knee malalignment 4. Any uncontrolled medical illness or an unstable treatment
or therapy
We found this trial at
49
sites
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