Overview

Long-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid Arthritis

Status:
Completed

Trial end date:
2008-05-01

Target enrollment:
0

Participant gender:
All

Summary

Trial to study the safety of a single, intravenous administration of long-circulating liposomal prednisolone disodium phosphate in patients with active rheumatoid arthritis.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Radboud University

Collaborator:

Utrecht University

Treatments:

Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate

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

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