Randomized placebo-controlled trial to investigate clinical efficacy, anti-inflammatory properties andsafety of prednisolone in hand osteoarthritis: a proof-of-concept study - HOPE

eiden University Medical Center0 个研究点目标入组 90 人开始时间: 2015年4月15日最近更新: 2018年11月12日

适应症

试验速览

暂无简介。

•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 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 70
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•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 breast-feeding during the trial, positive rheumatoid factor or anti-CCP 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