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About
In response to the high prevalence of synovitis in hand osteoarthritis (OA) and its association with pain, there's a compelling rationale for investigating the efficacy of MTX in managing inflammatory erosive hand OA. Recent guidelines highlight the need for large, well-designed trials to assess the effectiveness of MTX. A recent trial (METHODS study) showed promising pain reduction with MTX, but due to pandemic-related protocol changes, the duration of the study was limited to six months. The ongoing MERINO trial randomizes participants to MTX or placebo for one year. After completing the MERINO trial, several participants asked for MTX open label. In the subsequent MERINO:2 study, participants completing the trial will be invited to a structured follow-up after one year, including electronic questionnaires and hand radiographs, providing valuable long-term data on the effects of MTX in hand OA. Together, these trials aim to fill gaps in understanding the long-term impact of MTX in hand OA, particularly on structural progression.
Full description
The primary aim is to demonstrate the superiority of Methotrexate (MTX) over no treatment in slowing radiographic progression over 24 months in individuals with erosive hand osteoarthritis (OA).
OA is a leading cause of disability and affecting millions worldwide, with a significant impact on knee, hip, and hand joints. Despite its high prevalence and symptomatic burden, effective disease-modifying treatments remain elusive, with current options limited to pain management and joint replacement.
MTX, recognized for its disease-modifying effects in systemic inflammatory joint diseases, offers promising potential in OA treatment, with previous trials indicating its anti-inflammatory properties and potential for joint damage reduction. In the ongoing MERINO trial, 153 participants are randomly assigned to either MTX or a placebo. Following completion of the trial, several participants have expressed interest in MTX treatment, which is sometimes used off-label for erosive hand OA patients experiencing unmanageable pain and inflammation. As a result, some MERINO trial participants will receive MTX treatment.
In the MERINO:2 study, we will conduct a structured follow-up one year post-MERINO trial completion, incorporating hand radiographs and pain questionnaires. This endeavor will furnish invaluable insights into the long-term effects of MTX treatment in erosive hand OA, a gap in current knowledge, particularly regarding structural progression. This will provide valuable data on long-term effects of MTX treatment in erosive hand OA, which is not currently described in the literature, especially on structural progression.
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Inclusion and exclusion criteria
Eligible participants are those enrolled in the MERINO-trial (EudraCT number 2019-004641-33, Clincaltrials.gov number NCT04579848, REK ID 2020/187524, CTIS number 2023-510523-30-00).
Inclusion Criteria:
Exclusion Criteria:
Contraindications to methotrexate:
Chronic inflammatory rheumatic diseases (such as rheumatoid arthritis and psoriatic arthritis or gout), active inflammatory bowel disease, or positive rheumatoid factor or anti-CCP antibodies.
Other severe co-morbidities such as hemochromatosis, fibromyalgia, psoriasis, blood dyscrasias, and coagulation disorders, history of malignancy (except successfully treated squamous or basal cell skin carcinoma), uncontrolled diabetes mellitus, severe hypertension, unstable ischemic heart disease, severe heart failure, severe pulmonary disease, severe and/or opportunistic infections and/or chronic infections, active tuberculosis, positive human immunodeficiency virus (HIV) status, recent stroke, bone marrow hypoplasia, or demyelinating diseases of the central nervous system.
Other likely causes of hand symptoms: thoracic outlet syndrome, carpal tunnel disease, diabetic cheiropathy, injury in finger joints previous 6 months, or palmar tenosynovitis/trigger finger.
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 or NSAIDs, unless stable dosage for ≥1 month.
Symptomatic slow-acting drugs for OA (SYSADOA), unless stable dose for ≥3 months and require stable dose throughout the study.
Disease-modifying osteoarthritis drugs (DMOADs) previous three months.
Scheduled hand surgery during study participation.
Planning to start other treatments for hand OA in the study participation period.
Not able to adhere to the study visit schedule and protocol requirements.
108 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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