A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects Who Completed Preceding Study M13-390 With Adalimumab
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 40
- 主要终点
- Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48
研究概览
简要总结
A Phase 2b, open-label extension (OLE) study in rheumatoid arthritis (RA) patients designed to collect long-term safety, tolerability, efficacy, and immunogenicity data of the proposed new adalimumab formulation.
详细描述
All participants who completed Study NCT01712178 had an opportunity to enroll into the study and to receive the new adalimumab formulation at a dose of 40 mg every other week (eow) for an additional 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has completed the preceding Study M13-390 for rheumatoid arthritis and has not developed any discontinuation criteria from that study.
- •If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after last dose of study drug. Examples of approved methods of birth control include the following (see local informed consent for more detail):
- •Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD);
- •Hormonal contraceptives for 90 days prior to study drug administration;
- •A vasectomized partner.
- •Subjects must be able and willing to self-administer subcutaneous (SC) injections or have a qualified person available to administer SC injections.
- •Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, physical examination, laboratory profile performed at Baseline.
- •Subjects must be able and willing to provide written informed consent and to comply with the requirements of this study protocol.
排除标准
- •Ongoing infections at Week 0 that have NOT been successfully treated. Subjects with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated.
- •Subject currently uses or plans to use anti-retroviral therapy at any time during the study.
- •Subject plans to use any live vaccine during the study.
- •Positive pregnancy test at Baseline (Week 0).
- •Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
研究组 & 干预措施
New formulation of adalimumab 40 mg every other week
New formulation adalimumab 40 mg every other week
干预措施: New formulation adalimumab (Biological)
结局指标
主要结局
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48
时间窗: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met: * ≥ 20% improvement in tender joint count; * ≥ 20% improvement in swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Disability Index of the Health Assessment * CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))
Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48
时间窗: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met: * ≥ 50% improvement in tender joint count; * ≥ 50% improvement in swollen joint count; and * ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Disability Index of the Health Assessment * CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))
Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48
时间窗: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI \< 0.5.
Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48
时间窗: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
次要结局
- Percentage of Participants Positive for Anti-adalimumab Antibody(Week 24 through Week 48)