EUCTR2019-004468-23-GB进行中（未招募）1 期
Comparison of abatacept with tumor necrosis factor inhibitors in the treatment of rheumatoid arthritis pain: A phase IV trial - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •Active rheumatoid arthritis causing pain and functional impairment with DAS28 >5.1
- •Has already received usual care for inflammatory arthritis including conventional DMARD therapy e.g. methotrexate, sulfasalazine, leflunomide, hydroxychloroquine on stable dose of csDMARD at least 4 weeks prior to study drug initiation
- •Willing to participate in the study over a 12 month period
- •Desirably to have positive antibodies to cyclic citrullinated peptide (ACPA/CCP)
- •Between 18 and 75 years of age
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Pregnancy or pregnancy planned over next 12 months
- •Current or previous unsuccessful use of the biologics abatacept or adalimumab
- •Co-existing other autoimmune condition, e.g. systemic lupus erythematosus, Sjogren’s syndrome, connective tissue disease, fibromyalgia, osteoarthritis, gout
- •Recent surgery in the last 3 months or imminent surgery in the next 12 months
- •Unable to give informed consent
- •Previous history of cancer in the last 5 years
- •Previous history of multiple sclerosis
- •Uncontrolled heart failure, hypertension or diabetes mellitus
- •Known history of fibromyalgia or other chronic pain disorder
- •females of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation)
- •Since the majority of subjects entering into the trial will be taking anchor medication in the form of methotrexate, it is advised that subjects do not conceive during the period of the trial and double contraception is advised at all times during the trial
- •Female subjects should not be breastfeeding
研究者
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