NCT04579848

Methotrexate in Erosive Inflammatory Hand Osteoarthritis

The Methotrexate in ERosive INflammatory Osteoarthritis (MERINO) Trial: A Randomized Placebo-controlled Trial to Investigate Clinical Efficacy and Safety of Methotrexate in Erosive Inflammatory Hand Osteoarthritis.

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 163 (estimated)
• Sponsor: Diakonhjemmet Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A placebo-controlled randomized controlled trial exploring the effect of methotrexate on pain, function and structural outcomes in erosive inflammatory hand osteoarthritis.

Detailed description

The trial will include Norwegian adult males and females with symptomatic erosive inflammatory hand osteoarthritis. Participants will be randomized 1:1 to either: 1. Methotrexate oral x 1/week; weekly starting dose 15 mg for two weeks, followed by 20 mg the remaining weeks (intervention group). Dosage can be reduced to as low as 10 mg if higher doses are not tolerated. 2. Placebo (control group). Both arms will receive folic acid 1mg daily. The treatment duration for both groups is 52 weeks.

Conditions

• Hand Osteoarthritis
• Erosive Osteoarthritis

Interventions

Type	Name	Description
DRUG	Methotrexate Tablets	Methotrexate 2.5mg oral tablet.
DRUG	Placebo	Placebo capsule
DRUG	Folic Acid 1 MG	Folic acid

Timeline

• Start date: 2021-08-12
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2020-10-08
• Last updated: 2025-12-19

Locations

1 site across 1 country: Norway