A Post-trial Follow-up of MERINO Participants to Evaluate Long-term Effects of Methotrexate Treatment in Adults With Erosive Hand OA.
In response to the high prevalence of synovitis in hand osteoarthritis (OA) and its association with pain, there&amp;#39;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.
- EligibilityCriteria: Participants completing the MERINO trial, i.e. having erosive hand OA and being randomized to MTX or placebo for 12 months. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Eligible participants are those completing the MERINO-trial (EudraCT number 2019-004641-33, Clincaltrials.gov number NCT04579848, REK ID 2020/187524, CTIS number 2023-510523-30-00). - SamplingMethod: Non-Probability Sample