Gout inflammatory joint disease
Conditions
Interventions
All 20 included patients will be treated with monthly infusion of rasburicase,
0.20mg/kg intravenously for 6 months. To prevent infusion
reactions/anaphylaxis, patients will receive 5mg levocetirizi
Sponsors
Jan van Breemen Instituut
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Adults (age >=18 years) with severe tophaceous gout not responding to standard treatment or contraindications to standard treatment. • Made the decision, along with their treating physician, to begin treatment with rasburicase • Willing and able to give informed consent and adhere to visit/protocol schedules • Written informed consent
Exclusion criteria
Exclusion criteria: • Known glucose-6-phophate dehydrogenase deficiency or other cellular metabolic disorder causing hemolytic anemia • Recipient of an investigational drug within 4 weeks prior to study drug administration • Non-compensated congestive heart failure • Prior treatment with rasburicase or another recombinant uricase • Pregnancy or breastfeeding • Known allergy for rasburicase or added substances as described in the SmPC of Fasurtec
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is Gout Activity Score after 6 months of rasburicase treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will consist of serum uric acid concentration, a clinical evaluation of tophus load, patient reported outcome measures; MD-HAQ, GAQ and safety measures (AE/SAEs), anti-drug antibody titers and to investigate B-cells response against rasbirucase. | — |
Countries
Netherlands
Outcome results
None listed