Hand Osteoarthritis Prednisolone Efficacy study (HOPE)

Completed

Conditions: Hand osteoarthritisHandartrose

Registration Number: NL-OMON22902

Lead Sponsor: eiden University Medical Center, ReumaNederland (Dutch Arthritis Society)

Brief Summary: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32489-4/fulltext

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 92

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 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

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.