A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-981 to Placebo in Subjects With Erosive Hand Osteoarthritis

AbbVie0 sites132 target enrollmentMarch 2015

ConditionsErosive Hand Osteoarthritis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Erosive Hand Osteoarthritis
Sponsor: AbbVie
Enrollment: 132
Primary Endpoint: Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Week 16
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled study to compare the safety and efficacy of ABT-981 to placebo in subjects with erosive hand osteoarthritis.

Registry

clinicaltrials.gov

Start Date

March 2015

End Date

July 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AbbVie

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female between the ages of 35 to
•Must fulfill 1990 American College of Rheumatology (ACR) hand osteoarthritis (OA) criteria
•Must have radiographic evidence of erosive hand OA
•Have one or more clinical signs and symptoms of active inflammation in at least three hand joints
•Subject Assessment of Hand Pain Intensity in at least one hand is ≥ 6.

Exclusion Criteria

•Previous exposure to any anti-interleukin-1 treatment, to corticosteroids within 1 month prior to Screening, to intra-articular hyaluronic acid injection into hand joint(s) within 6 months prior to Screening, to any immunosuppressive biologic therapy within 1 month or 5 half-lives (whichever is longer) prior to the first dose of study drug, OR current use of immunosuppressive oral medications within 3 months or 5 half-lives (whichever is longer) prior to the first dose of study drug.
•Absolute neutrophil count \< 2,000 per mm3
•Diagnosis of one or more of the following:
•Fibromyalgia,
•Inflammatory arthritis such as rheumatoid arthritis, peripheral seronegative spondyloarthropathy,
•Psoriatic arthritis, psoriasis,
•Microcrystalline (including gout and pseudo gout) arthritis affecting the hands,
•Any OA of the hands due to an infectious origin or acute traumatic episode, secondary OA or OA linked to cartilage and bone dysplasia,
•Other chronic painful syndromes that could interfere with assessment of pain at the hand(s).
•Any uncontrolled medical illness or an unstable treatment or therapy.

Outcomes

Primary Outcomes

Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Week 16

Time Frame: Week 0 (Baseline), Week 16

The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The pain subdomain score ranges from 0 to 50; lower scores indicate better status. A decrease in the pain subdomain score represents improvement in status. Last Observation Carried Forward (LOCF): Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.

Secondary Outcomes

Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit(Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26)
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit(Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26)
Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit(Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26)
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit(Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26)
Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit(Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26)
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit(Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26)