CTIS2023-510523-30-00进行中（未招募）1 期
The Methotrexate in ERosive INflammatory Osteoarthritis (MERINO) trial: A randomized placebo-controlled trial to investigate clinical efficacy and safety of methotrexate in erosive inflammatory hand osteoarthritis
Diakonhjemmet Sykehus AS0 个研究点目标入组 153 人开始时间: 2024年1月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 153
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •Finger joint pain 40-80 on 0-100 VAS with insufficient pain relief from, inability to tolerate or contra-indications to oral paracetamol and/or NSAIDs, and hand symptoms (pain, aching, or stiffness) on most days the previous 6 weeks before randomization., Hand OA according to the ACR criteria, at least 1 distal (DIP) or proximal interphalangeal (PIP) joint of the 2nd-5th finger with radiographic pre-erosive (J-phase) or erosive disease (E-phase) according to the Verbruggen-Veys anatomical phase system, and at least two DIP/PIP joints with power Doppler signal of at least grade 1 or grey-scale synovitis of at least grade 2 on ultrasound.
排除标准
- •Contraindications for methotrexate, such as uncontrolled serious comorbidities, active or recurrent infections, malignancy, pregnancy and drug or substance abuse. • Other autoimmune or inflammatory rheumatic disease, or psoriasis. • Oral or intra-muscular steroids in the previous month. • Intra-articular treatments or aspirations of any kind of any joint in the hands 3 months before inclusion. • Analgesics, unless stable dosage for =1 month. • Symptomatic slow-acting drugs for OA (SYSADOA*), unless stable dose for =3 months. • Disease modifying osteoarthritis drugs (DMOADs**). The complete list of exclusion criteria is provided in the protocol.
研究者
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