Randomized placebo controlled trial to investigate clinical efficacy, anti-inflammatory properties and safety of prednisolone in hand osteoarthritis: a proof of conceptstudy

eiden University Medical Center, ReumaNederland (Dutch Arthritis Society)0 个研究点目标入组 92 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

•Patients of either sex with inflammatory” interphalangeal osteoarthritis, defined as at least 4 osteoarthritic
•interphalangeal joints (IPJs) with nodes, at least 1 IPJ with soft tissue swelling or erythema and at least 1 IPJ with positive power Doppler signal at US, will be recruited. All patients have to fulfill the American College of
•Rheumatology (ACR) criteria for hand osteoarthritis. A minimal amount of osteoarthritic digital pain (pain at rest
•>30 mm on VAS) that fluctuates upon drug administration (worsening by >20 mm on the VAS after NSAID wash
•out) is required. Patients have to use NSAIDs for digital joint pain. In case of digital pain and thumb base pain,
•digital pain has to be the most intense.

•Exclusion criteria comprise chronic inflammatory rheumatic disease (such as rheumatoid arthritis or gout),
•fibromyalgia, use of immunomodulating drugs (such as antimalarials and systemic or local corticosteroids)
•within 90 days, hyaluronic acid injections in the thumb base within 90 days, pregnancy or breastfeeding
•during the trial, positive rheumatoid factor or antiCCP
•antibodies, psoriasis, blood dyscrasias and coagulation
•disorders, malignancy (except successfully treated squamous or basal cell skin carcinoma), uncontrolled
•diabetes mellitus or hypertension, unstable ischemic heart disease, heart failure (New York Heart Association III/
•IV), severe pulmonary disease, recent stroke, bone marrow hypoplasia, elevated liver enzyme levels (aspartate transaminase (AST) and/or alanine transaminase (ALT) ≥2 times normal value), creatinine clearance ≤60 ml/min, latex sensitivity, drug or alcohol abuse in the last year, severe and opportunistic infections, chronic infections.

发起方

eiden University Medical Center, ReumaNederland (Dutch Arthritis Society)