JPRN-jRCT1031230107招募中4 期
A sarilumab-controlled, open-label, randomized controlled trial of baricitinib for residual joint pain in patients with methotrexate-resistant rheumatoid arthritis - REPAIR study
Ogasawara Michihiro0 个研究点目标入组 60 人开始时间: 2023年6月2日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 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
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Patients aged 18 years or older at the time of informed consent
- •2. Gender : Any
- •3. Treatment categories : outpatient/inpatient
- •4. Patients diagnosed with RA according to the ACR/EULAR Rheumatoid Arthritis Classification Criteria (2010)
- •5. Patients with moderate or greater disease activity (DAS28-ESR >= 3.2) at the time of eligibility assessment at enrollment
- •6. Patients with a pain VAS > 40 mm at enrollment
- •7. Patients with inadequate response to MTX who have been continuously treated with MTX for at least 8 weeks at the time of enrollment and have been receiving the same dose of 8 - 16 mg/week for at least 4 weeks (however, doses less than 8 mg/week are allowed only if there is intolerance to 8 mg/week or more)
- •8. Patients who have given written informed consent of their own free will after receiving sufficient explanation about participating in this study
排除标准
- •Patients who meet any one of the following criteria are excluded from the study.
- •1. Patients taking corticosteroids exceeding 5 mg/day equivalent to prednisolone
- •2. Patients with contraindications for baricitinib or sarilumab
- •3. Patients who have used JAK inhibitors and IL-6 inhibitors in the past
- •4. patients who have had a dose change of csDMARDs or corticosteroids within 4 weeks of enrollment
- •5. patients treated with a TNF inhibitor (infliximab, infliximab BS, adalimumab, adalimumab BS, golimumab, certolizumab pegol or ozoralizumab) or abatacept within 8 weeks of enrollment
- •6. patients treated with a TNF inhibitor (etanercept, etanercept BS) within 4 weeks of enrollment
- •7. patients using concomitant or concomitant prohibited therapies other than csDMARDs and the above-mentioned biologic agents within 4 weeks of enrollment
- •8. Diseases with joint symptoms other than RA (ankylosing spondylitis, reactive arthritis, psoriatic arthritis, crystal-induced arthritis, systemic lupus erythematosus, systemic scleroderma, inflammatory muscle disease, mixed connective tissue disease) patients with
- •9. Patients with cervical hernia, herpes zoster, diabetic neuropathy, and other diseases that cause neuropathic pain due to organic disorders
- •10. Patients with primary diagnosis of fibromyalgia
- •11. patients with psychotic disorders (e.g., schizophrenia, schizoaffective disorder, paranoid disorder), patients receiving treatment with selective serotonin reuptake inhibitors, monoamine oxidase inhibitors Patients receiving treatment with tricyclic, tetracyclic, or atypical antidepressants.
- •12. patients being treated with opioid analgesics.
- •13. patients treated with the investigational drug within the past 3 months.
- •14. patients with severe renal disease (serum creatinine level > 2.0 mg/dL)
- •15. patients with severe hepatic impairment (AST or ALT > 100 U/L)
- •16. lactating, pregnant, or trying to become pregnant, or patients who are unable to provide consent to use contraception from the time of eligibility assessment for 12 months after the last dose
- •17. Other patients who are deemed inappropriate as research subjects by the principal investigator (subinvestigator)
研究者
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