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

Study Identifier
M13-741
CT.gov Identifier
NCT02087904
EudraCT Identifier
2013-003467-60
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Osteoarthritis
    • Study Drug
  • ABT-981
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    35 - 74 Years
    Inclusion and Exclusion 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

    Protocol 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.

    Study Locations

    No locations found.