The 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…
ID
Bron
Verkorte titel
Aandoening
Hand osteoarthritis
Handartrose
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary endpoint is the change in digital joint pain after 6 weeks, assessed by a 100 mm VAS.
Achtergrond van het onderzoek
Randomised, placebo-controlled, double-blind, investigator-initiated trial to investigate the efficacy and safety of 6 week prednisolone 10 mg in patients with painful hand OA with signs of inflammation.
Doel van het onderzoek
The 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.
Onderzoeksopzet
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks and 14 weeks.
Onderzoeksproduct en/of interventie
Patients 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).
Publiek
Féline Kroon
PO Box 2300 RC
Leiden
The Netherlands
+31 71 56 3598
f.kroon.reum@lumc.nl
Wetenschappelijk
Féline Kroon
PO Box 2300 RC
Leiden
The Netherlands
+31 71 56 3598
f.kroon.reum@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5034 |
| NTR-old | NTR5263 |
| Ander register | 201500068733 : EudraCT |