Long-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid Arthritis
Drug: long-circulating liposomal prednisolone
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
|Official Title:||Long-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid Arthritis|
|Study Start Date:||October 2005|
|Study Completion Date:||May 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00241982
|Radboud University Nijmegen Medical Centre|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Principal Investigator:||P. Barrera, PhD||Radboud University|