NL-OMON42110已完成2 期
A Phase 2a, multicenter, randomized, double-blind, placebo-controlled study to compare the safety and efficacy of ABT-981 to placebo in subjects with erosive hand osteoarthritis - M14-171
AbbVie0 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Male or female between the ages of 35 to 80 years (inclusive) at the time of signing the informed consent.
- •2. Subject 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. Subject 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 (a qualified central reader will perform the eligibility reading
- •according to a pre-defined criterion).
- •4. Subject has 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.
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 (intravenous, oral, or injection) 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.). The number of subjects not undergoing an MRI will be limited to 10 per arm
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