Treatment with rasburicase results in a decrease in serum uric acid and tophi.
ID
Bron
Verkorte titel
Aandoening
Gout
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
serum uric acid (mmol/l)
Achtergrond van het onderzoek
The objective of the current investigation is to assess the efficacy and safety of rasburicase treatment in patients with severe gout. Patients will be treated with weekly infusion of rasburicase (0,15mg/kg) for 3 months. To prevent infusion reactions/anaphylaxis, patients will receive premadication (clemastine, methylprednisolon). The primary outcome is serum uric acid conentration after 3 months of treatment. Secondary outcomes will consist of a clinical evaluation of tophus load, patient reported outcome measures and safety measures.
Doel van het onderzoek
Treatment with rasburicase results in a decrease in serum uric acid and tophi.
Onderzoeksopzet
3 months, 26 weeks
Onderzoeksproduct en/of interventie
rasburicase 0,15mg/kg, once a week during 3 months. Premedication: clemastine and methylprednisolon.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Adults with severe tophaceous gout
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
non-compensated congestive heart failure, prior treatment with a recombinant uricase, pregnancy, known allergy for rasburicase or added substances as described in the SmPC of Fasurtec. Known glucose-6-phosphate dehydrogenase deficiency or other cellular metabolic disorder causing hemolytic anemia. Recipient of an investigational drug within 4 weeks prior to study drug administration.
Opzet
Deelname
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