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

This study has been completed.
Sponsor:
Collaborator:
Utrecht University
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00241982
First received: October 18, 2005
Last updated: May 28, 2008
Last verified: May 2008
  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 2

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

Resource links provided by NLM:


Further study details as provided by Radboud University:

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)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241982

Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Utrecht University
Investigators
Principal Investigator: P. Barrera, PhD Radboud University
  More Information

No publications provided

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)

Keywords provided by Radboud University:
rheumatoid arthritis
long circulating liposomes

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on October 20, 2014