临床试验/jRCT1071190016

jRCT1071190016已完成不适用

PROspective sarilumab (preFILled syringe/pen) obsErvational study - Japan (PROFILE-J)

未提供0 个研究点目标入组 2,000 人开始时间: 待定最近更新: 2024年9月19日

适应症

试验速览

阶段: 不适用
状态: 已完成
入组人数: 2,000
主要终点: -

研究概览入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Observational

入排标准

年龄范围: 20age old over 至 No limit（—）
性别: All

入选标准

•Adult patients.
•Patients with diagnosis of Rheumatoid Arthritis according to The 2010 American College of Rheumatology/European League Against Rheumatism classification criteria.
•Patients for whom the treating physician has made the decision to initiate sarilumab before patient inclusion and independently of the purpose of the study.
•Study enrollment is to be on the same day as the initiation of treatment or within a maximum of 4 weeks before the initiation of treatment.
•Signed written informed consent.

排除标准

•Patients for whom sarilumab is contra-indicated as described in Japanese package insert.
•Patients currently participating in any interventional clinical trials.
•Previous experience with sarilumab through either a clinical trial.
•Concomitant use of any bDMARDs or any tsDMARDs, including but not limited to etanercept, etanercept BS, adalimumab, adalimumab BS, infliximab, infliximab BS, anakinra, rituximab, rituximab BS, abatacept, tocilizumab, certolizumab, golimumab, tofacitinib, baricitinib, peficitinib, upadacitinib, filgotinib.
•Previously treated with sarilumab.
•Uncooperative, or any condition, that could make the patient potentially noncompliant to the study procedures, etc.

结局指标

主要结局

-

Change from baseline* in CDAI at weeks 24 and 52. *Baseline data are captured at enrollment visit.

次要结局

Laboratory disease parameters: ESR
Proportion of patients achieving CDAI remission(Weeks 12, 24, 36, and 52)
Proportion of patients achieving CDAI LDA(Weeks 12, 24, 36, and 52)
Patient characteristics
Change from baseline in CDAI(Weeks 12 and 36)
Proportion of patients achieving DAS28 remission(Weeks 12, 24, 36, and 52)
Proportion of patients achieving DAS28 LDA(Weeks 12, 24, 36, and 52)
Proportion of patients achieving SDAI remission(Weeks 12, 24, 36, and 52)
Proportion of patients achieving SDAI LDA(Weeks 12, 24, 36, and 52)
Change from baseline in TJC-28(Weeks 12, 24, 36, and 52)
Change from baseline in SJC-28(Weeks 12, 24, 36, and 52)
Change from baseline in PrGA-VAS(Weeks 12, 24, 36, and 52)
Laboratory disease parameters: CRP
Change from baseline in DAS28 - score(Weeks 12, 24, 36, and 52)
Change from baseline in SDAI(Weeks 12, 24, 36, and 52)
Radiographic outcomes(Week 52)
Proportion of patients with modification sarilumab therapy scheme
Proportion of patients on sarilumab 200 mg or 150 mg
Modification of dosage
Reasons for adjustments in sarilumab dose
Proportions of patients with dose change of csDMARD
Proportions of patients with no new prescription of csDMARD
Proportions of patients with dose change in corticosteroid use
Proportions of patients with no new prescription of corticosteroids
Use of statins
Change from Baseline in PROs(week 2, 4, 12, 24, 36, and 52)
Safety

研究者

发起方

未提供

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