Diakonhjemmet Hospital
Ida Kristin Haugen
A placebo-controlled randomized controlled trial exploring the effect of methotrexate on pain, function and structural outcomes in erosive inflammatory hand osteoarthritis.
Hand Osteoarthritis
Erosive Osteoarthritis
Methotrexate Tablets
Placebo
Folic Acid 1 MG
PHASE4
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.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 153 participants |
Masking : | QUADRUPLE |
Masking Description : | Identical placebo cannot be produced due to text, color and shape of methotrexate tablets. Thus, both placebo and methotrexate will be encapsulated to ensure blinding. |
Primary Purpose : | TREATMENT |
Official Title : | 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. |
Actual Study Start Date : | 2021-08-12 |
Estimated Primary Completion Date : | 2025-06-30 |
Estimated Study Completion Date : | 2025-12-31 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Diakonhjemmet Hospital
Oslo, Norway,