2023-510523-30-00招募中4 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 AS1 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2024年2月9日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Difference in self-reported finger joint pain previous 48 hours on a visual analogue scale (VAS; 0-100 mm) at 6 months (M06) of treatment.
研究概览
简要总结
To explore whether methotrexate can reduce finger joint pain in patients with symptomatic erosive inflammatory hand OA.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
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.
结局指标
主要结局
Difference in self-reported finger joint pain previous 48 hours on a visual analogue scale (VAS; 0-100 mm) at 6 months (M06) of treatment.
Difference in self-reported finger joint pain previous 48 hours on a visual analogue scale (VAS; 0-100 mm) at 6 months (M06) of treatment.
次要结局
- Fulfillment of Outcome Measures in Rheumatology Osteoarthritis Research Society International (OMERACT-OARSI) responder criteria (all visits).
- Self-reported finger pain previous 48 hours on a VAS (0-100 mm) (all visits).
- Self-reported thumb pain previous 48 hours on a VAS (0-100 mm) (all visits).
- Pain most painful finger joint last 48 hours (VAS) (all visits).
- Finger pain and thumb base pain (yes/no) on hand diagram (M00, M06).
- Patient-reported disease activity last 48 hours (VAS) (all visits).
- Australian/Canadian hand index (AUSCAN) (all visits).
- Quality-adjusted life years (QALYs) based on the health-related utility scores measured by the generic instrument EQ-5D (all visits).
- Michigan Hand Outcomes Questionnaire (MHOQ) pain and physical function subscales (M00, M06).
- Duration of morning stiffness in finger joints (M00, M06)
- Duration of morning stiffness in thumb base joints (M00, M06)
- Hospital Anxiety and Depression Scales (HADS) (M00, M06).
- Pain Catastrophizing Scale (PCS) (M00, M06).
- Pain Sensitivity Questionnaire (PSQ) (M00, M06).
- Knee injury and Osteoarthritis Outcome Score (KOOS)-12 (M00, M06).
- Hip disability and Osteoarthritis Outcome Score (HOOS)-12 (M00, M06).
- Concomitant medication (all visits).
- Number of tender and swollen joints (0-30) (all visits).
- Grip strength (in kg; using a hand dynamometer) (M00, M06, M12).
- Pain sensitization: Pressure Pain Thresholds (PPT) by digital algometer; temporal summation by punctate probes; Conditioned Pain Modulation (CPM) by blood pressure ischemic test (M00, M06).
- Ultrasound (screening, all visits): number of finger joints with synovial thickening and power Doppler signals.
- Conventional radiographs (screening, M06, M12): change in radiographic severity according to: o Kellgren-Lawrence scale o Verbruggen-Veys anatomical phase scoring system o Osteoarthritis Research Society International (OARSI) atlas for the presence/severity of osteophytes, joint space narrowing and erosions
- MRI (M00, M06): structural progression and synovitis on static and dynamic contrast-enhanced MRI sequences.
- Serum or plasma markers of extracellular matrix turnover, including collagens and aggrecan, and markers of inflammation (M00, M06, M12).
- Number of adverse events, serious adverse events, and withdrawals because of adverse events (all visits).
- Change in synovial cellular composition and gene expression with single-cell RNA sequencing analyses; subgroup analyses, n=16 patients (M00, M06).
- Self-reported knee pain previous 48 hours on a VAS (0-100) (M00, M06).
研究者
Coordinator
Scientific
Diakonhjemmet Sykehus AS
研究点 (1)
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