ISRCTN46471047CompletedNot Applicable
A multicentre, randomised, controlled, double-blind study, evaluating the efficacy and safety of anakinra in chondrocalcinosis (Étude multicentrique randomisée contrôlée en double-aveugle contre placebo, évaluant l?efficacité et la sécurité de l?anakinra dans la crise de chondrocalcinose articulaire)
niversity Hospital Centre and University of Lausanne (CHUV) (Switzerland)-Service of Rheumatology0 sites75 target enrollmentStarted: March 18, 2011Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 75
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Informed consent
- •2. Male or female from 18-99 years of age
- •3. Diagnosis of acute calcium pyrophosphate arthritis based on symptoms of acute arthritis and presence of crystals of chronic calcium pyrophosphate dihydrate (CPPD) in the synovial liquid at screening or from a prior analysis
- •4. The start of the acute arthritis should be less than 5 days from inclusion in the study
Exclusion Criteria
- •1. Corticotherapy orally with dose equivalent of prednisone > 10mg during the 24 h preceding inclusion
- •2. Corticotherapy intramuscular (im) or intravenous (iv) during the 72h preceding inclusion, no matter the dose
- •3. Corticotherapy intra-articularly during 7 days preceding inclusion
- •4. Chronic oral corticotherapy of > 10mg daily
- •5. Uncontrolled respiratory or cardiac failure
- •6. Other causes of acute arthritis
- •7. Active gastric or duodenal ulceration
- •8. Untreated and active malignancy
- •9. Known intolerance or allergy to the study medications
- •10. Active and untreated infection assessed by investigator as a contraindication to study medications
- •11. Other medical problems that are judged prejudicial to the inclusion of the patient in the study by the investigator
- •12. Pregancy or active breast feeding
Investigators
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