Phase 2
N=131
A Phase 2a Study Evaluating the Safety and Efficacy of ABT-981 in Patients With Erosive Hand Osteoarthritis
Erosive Hand Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT02384538 ↗Enrolled (actual)
131
Serious AEs
3.1%
Results posted
Jul 2017
Primary outcome: Primary: Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Week 16 — -10.74; -9.22 units on a scale — p=0.386
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ABT-981 (Biological); Placebo for ABT-981 (Biological)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Week 16 |
-10.74; -9.22 | 0.386 |
| SECONDARY Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit |
-3.25; -3.27; -5.01; -4.26; -8.90; -6.44 | — |
| SECONDARY Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit |
-6.23; -4.79; -8.43; -7.04; -14.25; -8.97 | 0.383 |
| SECONDARY Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit |
-0.74; -0.96; -0.98; -1.24; -1.51; -1.43 | 0.719 |
| SECONDARY Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit |
-10.01; -8.85; -14.06; -12.18; -24.52; -16.65 | 0.387 |
| SECONDARY Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit |
-0.62; -0.69; -1.18; -1.06; -2.40; -1.74 | 0.281 |
| SECONDARY Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit |
-0.52; -0.54; -1.31; -1.13; -1.85; -1.20 | 0.212 |
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
- 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:
- 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).
- Any uncontrolled medical illness or an unstable treatment or therapy.
- Any reason that prohibits a subject to undergo an MRI.
Data sourced from ClinicalTrials.gov (NCT02384538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.