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.

Who is this study for? Patients with erosive inflammatory hand osteoarthritis
What treatments are being studied? Methotrexate
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Finger joint pain 40-80 on 0-100 visual analog scale (VAS) with insufficient pain relief from, inability to tolerate or contra-indications to oral paracetamol and/or NSAIDs, and hand symptoms (pain, aching, or stiffness) on most days the previous 6 weeks before randomization.

• Hand OA according to the American College of Rheumatology (ACR) criteria, at least 1 distal (DIP) or proximal interphalangeal (PIP) joint of the 2nd-5th finger with radiographic pre-erosive (J-phase) or erosive disease (E-phase) according to the Verbruggen-Veys anatomical phase system, and at least two DIP/PIP joints with power Doppler signal of at least grade 1 or grey-scale synovitis of at least grade 2 on ultrasound.

Locations
Other Locations
Norway
Diakonhjemmet Hospital
RECRUITING
Oslo
Contact Information
Primary
Ida K. Haugen, MD, PhD
ida.k.haugen@gmail.com
95859884
Backup
Alexander Mathiessen, MD, PhD
alexander_mathiessen@hotmail.com
97501889
Time Frame
Start Date: 2021-08-12
Estimated Completion Date: 2026-12
Participants
Target number of participants: 163
Treatments
Active_comparator: Methotrexate
Methotrexate oral x 1/week; weekly starting dose 15 mg for two weeks, followed by 20 mg the remaining weeks.~Additional Folic acid 1mg prescribed daily.
Placebo_comparator: Placebo
3 capsules per week for two weeks, followed by 4 capsules the remaining weeks.~Additional Folic acid 1mg prescribed daily.
Related Therapeutic Areas
Sponsors
Leads: Diakonhjemmet Hospital
Collaborators: Oslo University Hospital

This content was sourced from clinicaltrials.gov