Overview

This trial has been completed.

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 288 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

  • 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 4. 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 December 2016.
Information provided to ClinicalTrials.gov by AbbVie.