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

NCT06281184 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 108

Last updated 2025-04-24

No results posted yet for this study

Summary

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.

Conditions

  • Hand Osteoarthritis
  • Erosive Osteoarthritis

Interventions

DRUG

Methotrexate

Methotrexate 5-25 mg x 1 per week, combined with folic acid 1mg daily.

OTHER

Treatment as usual

No specific treatment after MERINO-trial

Sponsors & Collaborators

  • Diakonhjemmet Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-29
Primary Completion
2027-12-01
Completion
2027-12-01
FDA Drug
Yes

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06281184 on ClinicalTrials.gov