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

AbbVie

Status and phase: Completed; Phase 2

Conditions: Erosive Hand Osteoarthritis

Treatments: Biological: Placebo for ABT-981; Biological: ABT-981

Study type: Interventional

Funder types: Industry

Identifiers

NCT02384538

M14-171

2014-001096-31 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.

Treatment:

Biological: Placebo for ABT-981

ABT-981

Experimental group

Description:

ABT-981 200 mg every two weeks (Q2W) for 24 weeks.

Treatment:

Biological: ABT-981