Rheumatoid Arthritis Clinical Trial
Official title:
Long-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid Arthritis
Trial to study the safety of a single, intravenous administration of long-circulating liposomal prednisolone disodium phosphate in patients with active rheumatoid arthritis.
A proof of concept, dose-escalating trial to study the safety of a single, intravenous
administration of long-circulating liposomal prednisolone disodium phosphate in patients
with active rheumatoid arthritis.
Secondary goals: To compare the therapeutic effect of this intervention with that of a
single intramuscular administration of 120 mg methylprednisolone (Depo-Medrol, Pharmacia).
The latter is commonly used in the clinics as bridging therapy. To assess the effect of
these interventions at the synovial tissue level.
On the longer term, the goal of liposomal corticosteroids is to achieve an increased
efficacy/safety ratio compared to standard treatment with free corticosteroids.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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