ISRCTN68663074进行中(未招募)4 期
Chronotherapy in Inflammatory Arthritis: a randomized controlled trial comparing the effectiveness of morning and evening dosing of tofacitinib extended-release
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中(未招募)
- 发起方
- Erasmus MC
- 入组人数
- 84
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
- 性别
- All
入选标准
- •Current inclusion criteria as of 21/11/2023:
- •1. Age =18 years
- •2. Diagnosed with rheumatoid arthritis (RA) or psoriatic arthritis (PsA), according to respectively the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 criteria for RA and ClASsification for Psoriatic ARthritis (CASPAR) criteria
- •3. Active disease, defined as a Disease Activity Score (DAS) >2.4 or Disease Activity in PSoriatic Arthritis (DAPSA) score >14
- •Previous inclusion criteria:
- •1. Age =18 years
- •2. Diagnosed with rheumatoid arthritis (RA) or psoriatic arthritis (PsA), according to respectively the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 criteria for RA and ClASsification for Psoriatic ARthritis (CASPAR) criteria
- •3. Active disease, defined as a Disease Activity Score (DAS) >2.4 or Disease Activity in PSoriatic Arthritis (DAPSA) score >14
- •4. Biological disease-modifying antirheumatic drug (bDMARD) usage <3
排除标准
- •1. Current or previous treatment with a targeted synthetic (ts)DMARD
- •2. Prednisone (or equivalent) at a dose of >7.5 mg
- •3. (Relative) contraindications for the study medication
- •4. Work in shifts
- •5. Not being able to understand, speak and write in Dutch
研究者
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Comparing the effectiveness of tofacitinib extended release (XR) chronotherapy, morning versus evening dosing, in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients from a patient’s, clinical as well as a translational point of view.Rheumatoid arthritis or psoriatic arthritis according to respectively 2010 criteria or CASPAR criteriaMedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2021-004131-84-NLErasmus Medical Center84
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