JPRN-jRCTs071200107暂停未知
Efficacy and safety of selective JAK 1 inhibitor Filgotinib in active rheumatoid arthritis patients with inadequate response to conventional synthetic disease-modifying antirheumatic drugs: Comparative study with Filgotinib and interleukin 6 inhibitor examined by clinical index as well as musculoskeletal ultrasound assessment(TRANSFORM study): Study protocol for a randomized, open-label, parallel-group, multicenter, and non-inferiority clinical trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 暂停
- 入组人数
- 400
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 providing consent.
- •2)Patients diagnosed as having RA according to the 2010 RA classification criteria of the American College of Rheumatology/European League Against Rheumatology.
- •3)Patients with moderate or more disease activity (DAS28-ESR >= 3.2) at the time of the eligibility evaluation.
- •4) Patients who have been treated with csDMARDs (any or combination of MTX, sodium gold thiolate, auranofin, penicillamine, salazosulfapyridine, lobenzalit, busiramine, actalit, tacrolimus, mizoribine, leflunomide, and iguratimod) for at least 8 weeks at the time of consent and did not have sufficient response after 4-week or longer csDMARDs treatment without modifying the dose.
- •5)Patients who can personally provide written consent at their own free will after being receiving a thorough explanation of the study and fully understanding their participation in the study.
排除标准
- •1) Patients receiving more than 5 mg per day of prednisolone equivalent of corticosteroids.
- •2)Patients with contraindications for filgotinib, tocilizumab and sarilumab treatment.
- •3)Patients with a history of using filgotinib.
- •4) Patients treated with corticosteroid but have modified the dose within 4 weeks prior to the time of consent.
- •5) Patients who have received treatment with TNF inhibitors (ie, infliximab, infliximab BS, adalimumab, adalimumab BS, golimumab, and certolizumab pegol), IL-6 inhibitors (tocilizumab and sarilumab) and abatacept within 8 weeks prior to the time of providing consent.
- •6)Patients who have received TNF inhibitors (ie. etanercept and etanercept BS) within 4 weeks prior to the time of consent.
- •7)Patients who have received anti-rheumatic molecular targeted drugs (ie. tofacitinib, baricitinib, peficitinib and upadacitinib) within 4 weeks prior to the time of consent.
- •8)Patients who have used non-steroidal anti-inflammatory analgesics (suppositories), intra-articular injections, investigational drugs, or medical devices under development within 4 weeks prior to the time of consent.
- •9) Patients with concurrent musculoskeletal disorders other than RA (i.e. ankylosing spondyloarthritis, reactive arthritis, psoriatic arthritis, crystal-induced arthritis, systemic lupus erythematosus, systemic scleroderma, inflammatory myopathy and mixed connective tissue disease).
- •10)Women who are breastfeeding, pregnant, or wish to fall pregnant, and those who do not consent to use contraception from the time of the eligibility evaluation until 12 months after the final dose of the investigational drug.
- •11)Individuals who, for other reasons, are deemed ineligible of study participation by the principal investigator.
研究者
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