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

Phase 1

Conditions: Adult male and female patients with erosive hand osteoarthritis
MedDRA version: 18.1Level: LLTClassification code 10019115Term: Hand osteoarthritisSystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2014-001096-31-BE

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

1. Male or female between the ages of 35 to 80 years (inclusive)
2. Must fulfill 1990 American College of Rheumatology (ACR) hand OA criteria, defined as hand pain, aching, or stiffness and three or four of the following features:
•hard tissue enlargement of two or more of the following 10 selected joints: the second and third distal interphalangeal (DIP) joint of both hands, the second and third proximal interphalangeal (PIP) joints of both hands, the first carpometacarpal (CMC) joints of both hands,
•hard tissue enlargement of two or more DIP joints,
•fewer than three swollen metacarpophalangeal (MCP) joints, and
•deformity of at least one of the 10 selected joints.
3. Must have radiographic evidence of erosive hand OA with evidence of an E (erosive) or E/R (erosive with remodeling) joint as defined by Verbruggen and colleagues in at least one of the hand interphalangeal joints based on hand x-rays obtained during the Screening Period or within 3 months of the Screening Visit
4. Have one or more clinical signs and symptoms of active inflammation in at least three hand joints, with active inflammation defined as localized tenderness and/or soft tissue swelling at Screening and Day 1 Visit.
5. Subject Assessment of Hand Pain Intensity in at least one hand is = 6 (11-point Numeric Rating Scale [NRS-11]) at Screening and Day 1 Visit.
6. Patient Global Assessment of Arthritis Status is = 6 (NRS-11) at Screening and Day 1 Visit.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1. Previous exposure to any anti-IL-1 treatment including (and not limited to) anakinra, canakinumab and rilonacept OR one or more of the following:
•Oral, intramuscular (IM), intravenous (IV), epidural or intra-articular corticosteroids within 1 month prior to Screening,
•Intra-articular hyaluronic acid injection into hand joint(s) within 6 months prior to Screening,
•Any investigational drug product of chemical or biologic nature within 1 month or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug,
•Any immunosuppressive biologic therapy including (and not limited to), etanercept, adalimumab, infliximab, golimumab, certolizumab, abatacept, tocilizumab, natalizumab, efalizumab, ustekinumab, belimumab or rituximab within 1 month or 5 half-lives (whichever is longer) prior to the first dose of study drug,
•Current use of immunosuppressive oral medications including (and not limited to) Tofacitinib, hydroxychloroquine, azathioprine, methotrexate, leflunomide, mycophenolate, sulfasalazine, gold, cyclophosphamide, penicillamine and/or tacrolimus, or tetracycline based agents within 3 months or 5 half-lives (whichever is longer) prior to the first dose of study drug,
•Colchicine within 1 month prior to the first dose of study drug,
•Vaccination with a live viral agent (including live attenuated influenza vaccine via nasal spray) = 30 day prior to Screening Visit through 10 weeks (5 × the half-life of ABT-981) after the last dose of study drug.
2. Absolute neutrophil count (ANC) < 2,000/mm3 at Screening.
3. Diagnosis of one or more of the following:
•Fibromyalgia,
•Inflammatory arthritis such as rheumatoid arthritis, peripheral seronegative spondyloarthropathy,
•Psoriatic arthritis, evidence of 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 due to (but not limited to) hemochromatosis, alkaptonuria, Wilson's disease, acromegaly and/or hyperparathyroidism,
•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. Clinically significant cardiac disease (including MI, coronary stenting or CVA) within last 12 months of Study Day 1 or clinically significant findings at Screening ECG including QT interval corrected for heart rate by Fridericia's formula (QTcF) > 470 msec in females or > 450 msec in males or PR interval > 220 msec.
6. Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) within the past 5 years other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
7. History of persistent chronic or active infection(s) requiring hospitalization or treatment with antimicrobials/antibiotics within 1 month prior to the first dose of study drug.
8. Any reason that prohibits a subject to undergo an MRI (e.g., pacemaker, certain types of metal implants, etc.).