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A 30-month Follow-up of MERINO Participants to Evaluate Long-term Effects of Methotrexate in Erosive Hand OA.

Study acronym: MERINO:2
StatusEnrolling by Invitation
PhaseNot specified
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Enrolling by Invitationv2 Show 7 more changesShow less
    • Primary and study completion dates: Feb 1, 2027 to Dec 1, 2027
    • Start date changed from estimate of Mar 15, 2024 to Jul 29, 2024
    • Interventions: Methotrexate (Drug), No treatment (Other) to Methotrexate (Drug), Treatment as usual (Other)
    • Eligibility criteria expanded, about 458 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site contact updated
    • Study title shortened, about 3 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06281184
Lead Sponsor Diakonhjemmet Hospital
Conditions
(from sponsor)		 Hand Osteoarthritis, Erosive Osteoarthritis
Enrollment 108 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov