NCT00686439已完成1 期
HUM 06-087: Proof of Concept Study : Adalimumab for the Treatment of Osteoarthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- OARSI/OMERACT response
研究概览
简要总结
We will conduct a pilot study of the effectiveness of adalimumab for inflammatory osteoarthritis.
详细描述
This is a 20 patient pilot open-label study of the efficacy of adalimumab in inflammatory osteoarthritis of the knee. Primary endpoint is at 12 weeks and primary outcome is the OARSI responder index.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 40 years of age or older.
- •If female, patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD) contraceptives (oral or parenteral) for three months prior to study drug administration),a vasectomized partner, total abstinence from sexual intercourse
- •If patient is female and of childbearing potential, the results of a serum pregnancy test performed at Screening, prior to the first dose of adalimumab, must be negative.
- •Patient has a diagnosis of OA of the index knee according to American College of Rheumatology criteria, including radiological evidence of OA (Kellgren-Lawrence grades 2 or 3).
- •Patient has had continual pain for at least 6 months prior to inclusion in the study. This includes pain that has persisted despite conventional treatment, defined as any one of the following medications taken daily during the preceding month:acetaminophen (2- 4 grams per day)maximum tolerated and recommended doses of an NSAID, acetaminophen/codeine combination (i.e. Tylenol No 2, 3, 4) taken at least 3 times daily
- •Patient has had daily knee pain for the month preceding study enrolment.
- •Patient has a summed pain score of 125-400mm (visual analog scale) on the WOMAC pain sub-scale in the index (more symptomatic) knee.
- •Patient has clinical evidence of a knee effusion in the index (more symptomatic) knee at Screening and Baseline.
排除标准
- •Subject has a history of an allergic reaction or significant sensitivity to constituents of Adalimumab.
- •Patient has a history of proven systemic arthritis such as rheumatoid arthritis.
- •Patient has a concurrent medical or arthritic condition that could confound evaluation of the index joint e.g. post-traumatic or any secondary form of knee OA
- •Patient has predominant patellofemoral disease
研究组 & 干预措施
adalimumab
Experimental
干预措施: adalimumab (Drug)
结局指标
主要结局
OARSI/OMERACT response
时间窗: 12 weeks
次要结局
- WOMAC Patient Global MRI(12 weeks)
研究者
Walter Maksymowych
F.R.C.P.(C),Professor of Medicine, Consultant Rheumatologist
University of Alberta
研究点 (1)
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