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| Sponsor: | Radboud University |
|---|---|
| Collaborator: |
Utrecht University |
| Information provided by: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT00241982 |
Purpose
Trial to study the safety of a single, intravenous administration of long-circulating liposomal prednisolone disodium phosphate in patients with active rheumatoid arthritis.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: long-circulating liposomal prednisolone |
Phase II |
| Study Type: | Interventional |
| 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 |
| Enrollment: | 22 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
-
Contacts and Locations| Netherlands | |
| Radboud University Nijmegen Medical Centre | |
| Nijmegen, Gelderland, Netherlands, 6500 HB | |
| Principal Investigator: | P. Barrera, PhD | Radboud University |
More Information
| Responsible Party: | Dr. Pilar Barrera, Radboud University |
| ClinicalTrials.gov Identifier: | NCT00241982 History of Changes |
| Other Study ID Numbers: | liposomal prednisolone |
| Study First Received: | October 18, 2005 |
| Last Updated: | May 28, 2008 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
rheumatoid arthritis long circulating liposomes |
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methylprednisolone acetate Prednisolone acetate Prednisolone Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents |
Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents |