EUCTR2013-002790-22-CZ进行中（未招募）1 期
An open-label, randomized, parallel group study assessing the immunogenicity and safety of sarilumab administered as monotherapy in patients with active rheumatoid arthritis - SARIL-RA-ONE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •Diagnosis of rheumatoid arthitis RA = 3 months.
- •Moderately to severely active rheumatoid arthritis.
- •Patients who per Investigator judgment were incomplete responders to at least 12 weeks of an adequate dose of continuous treatment with or who were intolerant of one or a combnation of non-biologic disease modifying anti-rheumatic drugs (DMARDs).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Patients < 18 years of age.
- •Past history of, or current, autoimmune or inflammatory systemic or localized joint disease(s) other than RA.
- •History of juvenile idiopathic arthritis or arthritis onset prior to age 16.
- •Severe active systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and/or Felty's syndrome.
- •Prior treatment with any biologic anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonist therapies.
- •Treatment with prednisone >10 mg or equivalent per day, or change in dosage within 4 weeks prior to randomization.
- •New treatment with or dose-adjustment of on-going nonsteroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors within 4 weeks prior to randomization, except for the use of low-dose acetylsalicylic acid for cardiovasculaire diseases.
- •Use of parenteral glucocorticoids or intra-articular glucocorticoids injection within 4 weeks prior to randomization.
- •Prior treatment with a Janus kinase (JAK) inhibitor (tofacitinib).
- •New treatment or dose-adjustment to on-going medication for dyslipidemia, such as statin, within 6 weeks prior to randomization.
- •Participation in any clinical research study evaluating another investigational drug or therapy within 5 half-lives or 60 days of first dose of study drug administration, whichever is longer.
- •Patients with a history of malignancy other than adequately-treated carcinoma in-situ of the cervix, nonmetastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the randimization visit. Nonmalignant lymphoproliferative disorders are also excluded.
- •Patients with active tuberculosis or untreated latent tuberculosis infection.
- •Pregnant or breast feeding women.
研究者
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