Long-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid Arthritis
Information source: Radboud University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: long-circulating liposomal prednisolone (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Radboud University Official(s) and/or principal investigator(s):
P. Barrera, PhD, Principal Investigator, Affiliation: Radboud University
Summary
Trial to study the safety of a single, intravenous administration of long-circulating
liposomal prednisolone disodium phosphate in patients with active rheumatoid arthritis.
Clinical Details
Official title: Long-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid Arthritis
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Safety/Efficacy Study
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
-
Locations and Contacts
Radboud University Nijmegen Medical Centre, Nijmegen, Gelderland 6500 HB, Netherlands
Additional Information
Starting date: October 2005
Ending date: May 2008
Last updated: May 28, 2008
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