Clinical trial NCT02384538: A Phase 2a Study Evaluating the Safety and Efficacy of ABT-981 in Patients With Erosive Hand Osteoarthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Erosive Hand Osteoarthritis
Keywords: Osteoarthritis
Joint diseases
Musculoskeletal diseases
Rheumatic diseases
Arthritis
Osteoarthritis, Hand
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-03-10
Enrollment: 132
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Week 16
timeFrame: Week 0 (Baseline), Week 16
Secondary outcomes:
measure: Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit
timeFrame: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26
measure: Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit
timeFrame: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26
measure: Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit
timeFrame: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26
measure: Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit
timeFrame: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26
measure: Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit
timeFrame: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26
measure: Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit
timeFrame: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc
role: STUDY_DIRECTOR
References:
citation: Kloppenburg M, Peterfy C, Haugen IK, Kroon F, Chen S, Wang L, Liu W, Levy G, Fleischmann RM, Berenbaum F, van der Heijde D, Bansal P, Wittoek R, Feng S, Fang Y, Saltarelli M, Medema JK, Levesque MC. Phase IIa, placebo-controlled, randomised study of lutikizumab, an anti-interleukin-1alpha and anti-interleukin-1beta dual variable domain immunoglobulin, in patients with erosive hand osteoarthritis. Ann Rheum Dis. 2019 Mar;78(3):413-420. doi: 10.1136/annrheumdis-2018-213336. Epub 2018 Dec 14.