Overview

This trial is active, not recruiting.

Conditions knee osteoarthritis, medial compartment knee osteoarthritis
Treatments abt-981, placebo
Phase phase 2
Sponsor AbbVie
Start date May 2014
End date December 2016
Trial size 320 participants
Trial identifier NCT02087904, 2013-003467-60, M13-741

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Low dose
abt-981
(Active Comparator)
Medium dose
abt-981
(Active Comparator)
High dose
abt-981
(Placebo Comparator)
Placebo
placebo

Primary Outcomes

Measure
Changes in Pain Score of the index knee
time frame: From Day 1 to Week 16
Change in synovitis/effusion volume of the index knee
time frame: From Day 1 to Week 26

Secondary Outcomes

Measure
Change in physical function
time frame: From Day 1 to Week 52
Change in index knee pain
time frame: From Day 1 to Week 52
Change in bone marrow lesions of the index knee
time frame: From Day 1 to Week 52
Change in index knee Intermittent and Constant Pain
time frame: From Day 1 to Week 52

Eligibility Criteria

Male or female participants from 35 years up to 74 years old.

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 malignment 5. Any uncontrolled medical illness or an unstable treatment or therapy

Additional Information

Official title A Phase 2a Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.