NL-OMON44904CompletedPhase 3
Randomized placebo-controlled trial to investigate clinical efficacy, anti-inflammatory properties and safety of prednisolone in hand osteoarthritis: a proof-of-concept study - HOPE
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 92
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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 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.
Investigators
Similar Trials
Active, not recruiting
Phase 1
Randomized placebo-controlled trial to investigate clinical efficacy, anti-inflammatory properties andsafety of prednisolone in hand osteoarthritis: a proof-of-concept studyHand osteoarthritisEUCTR2015-000687-33-NLeiden University Medical Center90
Completed
Not Applicable
The effect of vitamin D supplementation on muscle strength and function in UK South Asian womeNutritional, Metabolic, EndocrineVitamin D deficiencyISRCTN41610200The University of Sheffield100
Active, not recruiting
Not Applicable
A randomized placebo-controlled trial to investigate blood pressure lowering effects of folic acid in patients with borderline hypertension.EUCTR2005-000333-38-DEOrganisation name was not entered50
Terminated
Phase 4
Can the double orexin receptor antagonist suvorexant increase rapid eye movement (REM) sleep and improve sleep-dependent processing of emotional memories in healthy adults?PTSDMental Health - Other mental health disordersACTRN12619001694101The University of Melbourne30
Withdrawn
Not Applicable
The Vaccination Infant Supplementation (VISS) Study - assessing the effect of vitamin D and probiotic supplementation around vaccination on infant's temperature and sleep pattern.ACTRN12618001992291AProf Dr Karin Ried50