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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00241982
• Date of registration: 18/10/2005
• Prospective Registration: No
• Primary sponsor: Radboud University
• Public title: Long-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid Arthritis
• Scientific title: Long-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid Arthritis
• Date of first enrolment: October 2005
• Target sample size: 22
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00241982
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Netherlands

Contacts

• Name: P. Barrera, PhD
• Affiliation: Radboud University

Key inclusion & exclusion 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

-



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: long-circulating liposomal prednisolone

Secondary ID(s)

liposomal prednisolone

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Utrecht University