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Hand Osteoarthritis Prednisolone Efficacy study (HOPE)


- candidate number22384
- NTR NumberNTR5263
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-jun-2015
- Secondary IDsEudraCT 201500068733
- Public TitleHand Osteoarthritis Prednisolone Efficacy study (HOPE)
- Scientific TitleRandomized placebo controlled trial to investigate clinical efficacy, anti-inflammatory properties and safety of prednisolone in hand osteoarthritis: a proof of concept study
- ACRONYMHOPE
- hypothesisThe main objective of this study will be to identify a possible new treatment to alleviate pain and diminish inflammation in patients with hand osteoarthritis. Secondary objectives are to increase our knowledge on the role of synovial inflammation on symptoms and on the sensitivity-to-change of questionnaires and imaging instruments in hand osteoarthritis.
- Healt Condition(s) or Problem(s) studiedHand Osteoarthritis
- Inclusion criteriaPatients 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 criteriaExclusion 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2015
- planned closingdate
- Target number of participants90
- InterventionsPatients in the intervention group will receive 2 ml prednisolone oral solution once daily (10 mg) during 6 weeks. The control group will receive 2 ml placebo oral solution once daily during 6 weeks. After 6 weeks the medication will be tapered (one week of 1 ml prednisolone oral solution once daily (5 mg) or 1 ml placebo oral solution once daily and thereafter one week 0.5 ml prednisolone oral solution once daily (2.5 mg) or 0.5 ml placebo oral solution once daily).
- Primary outcomeThe primary endpoint is the change in digital joint pain after 6 weeks, assessed by a 100 mm VAS.
- Secondary outcomeThe secondary endpoints are:
- Change in joint pain after 6 weeks assessed by AUSCAN pain subscale;
- Change in thumb base pain after 6 weeks assessed by a 100 mm VAS;
- Change in physical function after 6 weeks assessed by AUSCAN physical function subscale;
- Change in physical function after 6 weeks assessed by FIHOA;
- Change in physical function after 6 weeks assessed by HAQ;
- Change in patient global assessment after 6 weeks assessed by a 100 mm VAS;
- Change in physician global assessment after 6 weeks assessed by a 100 mm VAS;
- Change in number of hand joints with pain upon palpation (physical exam) after 6 weeks;
- Change in inflammatory ultrasonography signs after 6 weeks;
- Change in MRI inflammatory signs after 6 weeks;
- Change in quality of life assessed by SF-36 after 6 weeks;
- Change in grip strength after 6 weeks;
- Fulfilment of OARSI responder criteria(19) after 6 weeks;
- Change in pain, physical function, patient and physician global assessment and quality of life after 8 weeks;
- Change in pain, physical function, patient and physician global assessment, number of painful joints upon palpation, inflammatory signs at US, quality of life, grip strength, and fulfilment of OARSI responder criteria after 14 weeks.
As exploratory parameters we will collect the following questionnaires: fatigue on a 100 mm VAS (baseline, 6 and 14 weeks), Michigan Hand Outcomes Questionnaire (MHOQ) (baseline, 6 and 14 weeks), the Illness Perception Questionnaire (IPQ) (baseline and 14 weeks), the Coping with Rheumatic Stressors questionnaire (CORS) (baseline and 14 weeks), the Hospital Anxiety Depression Scale (HADS) (baseline), the modified painDETECT questionnaire (baseline and 6 weeks) and anchor questions regarding pain, physical function, fatigue and quality of life (after 6 weeks). We will assess hand function using the Moberg Pick Up Test at baseline, 6 and 14 weeks. We will assess hand mobility using different measures, e.g. the Modified Kapandji Index, HAMIS and fingertip-to-palm-distance at baseline, 6 and 14 weeks.
- TimepointsBaseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks and 14 weeks.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. F. Drs. F. Kroon
- CONTACT for SCIENTIFIC QUERIESDrs. F. Drs. F. Kroon
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Reumafonds
- PublicationsNo publications available yet
- Brief summary
- Main changes (audit trail)
- RECORD24-jun-2015 - 16-aug-2015


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