TUMOR NECROSIS FACTOR-ALPHA INHIBITION (ADALIMUMAB) IN OSTEOARTHRITIS

骨关节炎中的肿瘤坏死因子-α 抑制（阿达木单抗）

• 批准号: 7375300
• 负责人: MARK C GENOVESE
• 金额: $ 1.96万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7375300
• 关键词: TUMOR; NECROSIS; FACTOR; ALPHA; INHIBITION

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Hypothesis: Cytokine blockade with a human TNF-a monoclonal antibody (Adalimumab) is safe in the treatment of, and can improve the signs and symptoms of, inflammatory osteoarthritis (OA) of the hands. This will be a Phase II open-label pilot study of 12 patients with active erosive OA receiving Adalimumab 40 mg every other week for twelve weeks. Prior to study enrollment, each patient identified will have a clinical evaluation including medical history, physical examination, laboratory studies, vital signs (blood pressure, pulse, respiration, and oral temperature), PPD skin test, and a detailed list of concurrent medications. Results of laboratory tests required for eligibility will be reviewed and approved by a physician with inclusion/exclusion criteria met before patient receives study drug. Investigational drug will be supplied by Abbott Laboratories. The study drug will be provided as an injection solution in 1-mL pre-filled syringes containing 40 mg Adalimumab/0.8 mL (50 mg/mL concentration). Endpoints: The primary endpoint is the safety of treatment with Adalimumab in subjects with inflammatory OA following SC injections of 40 mg Adalimumab every other week for 12 weeks. To investigate the clinical efficacy of treatment with Adalimumab, co-primary endpoints will be observed: ACR20 at Week 12 and improvement in joint severity (inflammation and tenderness) at Week 12. The ACR 20 is defined by at least a 20% improvement from baseline in the number of tender and swollen joints and at least a 20% improvement in three of the five following domains: pain [based on visual analogue scale (VAS)], patient global assessment (PTGA), physician global assessment (MDGA), erythrocyte sedimentation rate, and Health Assessment Questionnaire disability index (HAQ-DI).

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心机构，不一定为研究者机构。假设：用人TNF-α单克隆抗体（阿达木单抗）阻断细胞因子治疗手部炎性骨关节炎（OA）是安全的，并且可以改善其体征和症状。 这将是一项II期开放标签初探性研究，12例活动性糜烂性OA患者接受阿达木单抗40 mg，每隔一周一次，持续12周。在研究入组前，将对确定的每例患者进行临床评价，包括病史、体格检查、实验室检查、生命体征（血压、脉搏、呼吸和口腔温度）、PPD皮肤试验和合并用药的详细列表。在患者接受研究药物前，将由符合入选/排除标准的医生审查和批准合格性所需的实验室检查结果。 研究药物将由Abbott Laboratories提供。研究药物将以注射液形式提供，装于1 mL预充式注射器中，含40 mg阿达木单抗/0.8 mL（50 mg/mL浓度）。 终点：主要终点是炎性OA受试者接受阿达木单抗40 mg SC注射（每2周一次，持续12周）后阿达木单抗治疗的安全性。 为了研究阿达木单抗治疗的临床疗效，将观察协同主要终点：第12周时的ACR 20和第12周时关节严重程度（炎症和压痛）的改善。ACR 20的定义是，关节疼痛和肿胀的数量较基线至少改善20%，并且以下五个领域中的三个领域至少改善20%：疼痛[基于视觉模拟量表（VAS）]、患者总体评估（PTGA）、医生总体评估（MDGA）、红细胞沉降率和健康评估问卷残疾指数（HAQ-DI）。