The Methotrexate in ERosive INflammatory Osteoarthritis (MERINO) trial - MERINO trial

Diakonhjemmet Hospital0 个研究点目标入组 210 人开始时间: 2020年9月25日最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•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 osteoarthritis 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 130
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

•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.

发起方

Diakonhjemmet Hospital