Rheumatoid Arthritis
Conditions
Keywords
rheumatoid arthritis, long circulating liposomes
Brief summary
Trial to study the safety of a single, intravenous administration of long-circulating liposomal prednisolone disodium phosphate in patients with active rheumatoid arthritis.
Detailed description
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.
Interventions
DRUGlong-circulating liposomal prednisolone
Sponsors
Utrecht University
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
In order to be enrolled in the study a patient must: Be aged 18 years or older Fulfill the revised 1987 ARA criteria for the classification of RA Have an active RA as defined by a Modified Disease Activity Score (DAS28) of more than 3.2 Have been on stable treatment with disease modifying anti-rheumatic drugs within 12 weeks prior to trial initiation Be able and willing to give voluntary written informed consent The indication for bridging therapy with systemic corticosteroids has been established by the caring rheumatologist -
Exclusion criteria
The patient must not Have been treated with oral corticosteroids within 2 weeks prior to baseline or with intraarticular or intramuscular corticosteroids within 8 weeks prior to baseline Have diabetes mellitus or abnormal renal, liver or haematological tests Have a clinically severe or unstable medical condition involving cardiac, pulmonary, liver and endocrine disorders or malignancies Have a previous history of bleeding or infectious disorders Be currently pregnant or breastfeeding \-
Countries
Netherlands
Outcome results
None listed