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A placebo-controlled randomized controlled trial exploring the effect of methotrexate on pain, function and structural outcomes in erosive inflammatory hand osteoarthritis.
Full description
The trial will include Norwegian adult males and females with symptomatic erosive inflammatory hand osteoarthritis.
Participants will be randomized 1:1 to either:
Both arms will receive folic acid 1mg daily.
The treatment duration for both groups is 52 weeks.
Enrollment
Sex
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Inclusion criteria
Exclusion criteria
A full list of the exclusion criteria for this study comprised the following:
Contraindications to methotrexate:
Chronic inflammatory rheumatic diseases (such as rheumatoid arthritis and psoriatic arthritis or gout), active inflammatory bowel disease, or positive rheumatoid factor or anti-CCP antibodies.
Other severe co-morbidities such as hemochromatosis, fibromyalgia, psoriasis, blood dyscrasias, and coagulation disorders, history of malignancy (except successfully treated squamous or basal cell skin carcinoma), uncontrolled diabetes mellitus, severe hypertension, unstable ischemic heart disease, severe heart failure, severe pulmonary disease, severe and/or opportunistic infections and/or chronic infections, active tuberculosis, positive human immunodeficiency virus (HIV) status, recent stroke, bone marrow hypoplasia, or demyelinating diseases of the central nervous system.
Other likely causes of hand symptoms: thoracic outlet syndrome, carpal tunnel disease, diabetic cheiropathy, injury in finger joints previous 6 months, or palmar tenosynovitis/trigger finger.
Oral or intra-muscular steroids in the previous month
Intra-articular treatments or aspirations of any kind of any joint in the hands 3 months before inclusion
Analgesics or NSAIDs, unless stable dosage for ≥1 month.
Symptomatic slow-acting drugs for OA (SYSADOA), unless stable dose for ≥3 months and require stable dose throughout the study.
Disease-modifying osteoarthritis drugs (DMOADs) previous three months.
Scheduled hand surgery during study participation.
Planning to start other treatments for hand OA in the study participation period.
Not able to adhere to the study visit schedule and protocol requirements.
Primary purpose
Allocation
Interventional model
Masking
153 participants in 2 patient groups, including a placebo group
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Central trial contact
Ida K. Haugen, MD, PhD; Alexander Mathiessen, MD, PhD
Data sourced from clinicaltrials.gov
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