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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02384538
• Date of registration: 05/03/2015
• Prospective Registration: No
• Primary sponsor: AbbVie
• Public title: A Phase 2a Study Evaluating the Safety and Efficacy of ABT-981 in Patients With Erosive Hand Osteoarthritis
• Scientific 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
• Date of first enrolment: March 2015
• Target sample size: 132
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02384538
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Belgium, Denmark, France, Netherlands, Switzerland, United States

Contacts

• Name: AbbVie Inc
• Affiliation: AbbVie

Key inclusion & exclusion 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.



Age minimum: 35 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Erosive Hand Osteoarthritis

Intervention(s)

Biological: ABT-981

Biological: Placebo for ABT-981

Primary Outcome(s)

Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Week 16 [Time Frame: Week 0 (Baseline), Week 16]

Secondary Outcome(s)

Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit [Time Frame: 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 [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 [Time Frame: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26]

Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit [Time Frame: 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 [Time Frame: 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 [Time Frame: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26]

Secondary ID(s)

2014-001096-31

M14-171

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/07/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02384538