No registrations found.
ID
Source
Brief title
Health condition
Gout
Sponsors and support
Intervention
Outcome measures
Primary outcome
serum uric acid (mmol/l)
Secondary outcome
patient related outcomes, safety measures.
Background summary
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.
Study objective
Treatment with rasburicase results in a decrease in serum uric acid and tophi.
Study design
3 months, 26 weeks
Intervention
rasburicase 0,15mg/kg, once a week during 3 months. Premedication: clemastine and methylprednisolon.
Inclusion criteria
Adults with severe tophaceous gout
Exclusion criteria
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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9180 |
| Other | METC VUmc : to determined |