A Phase 2a Study Evaluating the Safety and Efficacy of ABT-981 in Patients With Erosive Hand Osteoarthritis

AbbVie132 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

132

Conditions

Erosive Hand Osteoarthritis

Interventions

ABT-981BIOLOGICAL

ABT-981 administered by subcutaneous injection

Placebo for ABT-981BIOLOGICAL

Placebo for ABT-981 administered by subcutaneous injection

Eligibility

Sex: ALLMin age: 35 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female between the ages of 35 to 80. 2. Must fulfill 1990 American College of Rheumatology (ACR) hand osteoarthritis (OA) criteria 3. Must have radiographic evidence of erosive hand OA 4. Have one or more clinical signs and symptoms of active inflammation in at least three hand joints 5. Subject Assessment of Hand Pain Intensity in at least one hand is ≥ 6. Exclusion Criteria: 1. 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. 2. Absolute neutrophil count \< 2,000 per mm3 3. 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). 4. Any uncontrolled medical illness or an unstable treatment or therapy. 5. Any reason that prohibits a subject to undergo an MRI.

Outcomes

Primary Outcomes

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

Time frame: Week 0 (Baseline), Week 16

Secondary Outcomes

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

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. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.

Time frame: 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

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 physical function subdomain score ranges from 0 to 90; lower scores indicate better status. A decrease in the physical function subdomain score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.

Data from ClinicalTrials.gov

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