Methotrexate in Erosive Inflammatory Hand Osteoarthritis (NCT04579848) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Methotrexate in Erosive Inflammatory Hand Osteoarthritis
Norway163 participantsStarted 2021-08-12
Plain-language summary
A placebo-controlled randomized controlled trial exploring the effect of methotrexate on pain, function and structural outcomes in erosive inflammatory hand osteoarthritis.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
A full list of the exclusion criteria for this study comprised the following:
* Contraindications to methotrexate:
* Abnormal renal function, defined as serum creatinine \>142 µmol/L in women and \>168 µmol/L in men, or a glomeruli filtration rate (GFR) \<40 mL/min/1.73 m2.
* Abnormal liver function, defined as transaminases above the upper normal limit, active or previous hepatitis B or C infection, or known cirrhosis
* Lung fibrosis (maximum 6 months old x-ray), active infection, or reduced hematopoiesis (i.e. anemia, leukopenia and/or thrombocytopenia).
* Planned pregnancy within 18 months after screening (men/women), and pregnancy, breastfeeding, or insufficient anti-conception therapy for female fertile participants. Contracept…