CompletedPhase 2

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

132 participantsStarted 2015-03

Plain-language 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.

Who can participate

Age range35 Years – 80 Years

SexALL

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Inclusion criteria

✓. Male or female between the ages of 35 to 80.
✓. 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:
✕. Any uncontrolled medical illness or an unstable treatment or therapy.
✕. Any reason that prohibits a subject to undergo an MRI.

What they're measuring

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

Timeframe: Week 0 (Baseline), Week 16

Trial details

NCT IDNCT02384538

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-07

Results submitted2017-06-12

View on ClinicalTrials.gov More Erosive Hand Osteoarthritis trials