EUCTR2014-001096-31-BE进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.).
研究者
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