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

Phase 1

Conditions: Hand osteoarthritis
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2015-000687-33-NL

Lead Sponsor: eiden University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of this study is to identify a new treatment to alleviate pain and diminish inflammation in patients with hand osteoarthritis with symptoms and signs of inflammation.;Secondary Objective: The secondary objectives of this study are to increase our knowledge on synovial inflammation in hand osteoarthritis, e.g. it’s role in pain experience, it’s course over three months and it’s responsiveness to prednisolone. Moreover, we want to gain insight in the differences in sensitivity-to-change of several instruments to assess pain, physical function, and synovitis in patients with hand osteoarthritis.;Primary end point(s): The primary endpoint is the change in digital joint pain after 6 weeks, assessed by a 100 mm VAS.;Timepoint(s) of evaluation of this end point: After 6 weeks.

Secondary Outcome Measures