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Sponsors and Collaborators: |
Erasmus Medical Center Novartis |
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Information provided by: | Erasmus Medical Center |
ClinicalTrials.gov Identifier: | NCT00504244 |
This study is designed to explore the use of myfortic ® in patients with active lupus erythematosus. Similar drugs in this class are increasingly used in organ transplantation and in autoimmune diseases. With the established safety profile of myfortic ® in allo-transplantation and the already existing data of mycophenolate mofetil in autoimmune diseases, this study should help to demonstrate the beneficial effect of myfortic ® on lupus activity. The aim of the study will be to show a decreased disease activity with myfortic ® compared to standard maintenance therapy with azathioprine.
Condition | Intervention | Phase |
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Systemic Lupus Erythematosus |
Drug: switch to Myfortic Drug: continuation of azathioprine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Multicenter Study to Assess the Efficacy on Diseases Activity of Enteric-Coated Mycophenolate Sodium Versus Continuation of Azathioprine in Patients With Systemic Lupus Erythematosus on Azathioprine Maintenance Therapy. |
Estimated Enrollment: | 48 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | July 2009 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Paul L van Daele, MD, PhD | +31 10 463 5954 | p.l.a.vandaele@erasmusmc.nl |
Contact: Martin van Hagen, MD, PhD | +31 10 4639222 | p.m.vanhagen @erasmusmc.nl |
Netherlands | |
Erasmus MC | Recruiting |
Rotterdam, Netherlands, 3015 CE |
Principal Investigator: | Paul LA van Daele, MD, PhD | Erasmus MC |
Study ID Numbers: | CERL080ANL07 |
Study First Received: | July 18, 2007 |
Last Updated: | July 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00504244 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
SLE SLEDAI Azathioprine Myfortic |
Antimetabolites Anti-Bacterial Agents Azathioprine Autoimmune Diseases Immunologic Factors Lupus Erythematosus, Systemic |
Lupus Mycophenolate mofetil Mycophenolic Acid Connective Tissue Diseases Antirheumatic Agents Immunosuppressive Agents |
Antimetabolites Autoimmune Diseases Antimetabolites, Antineoplastic Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Mycophenolic Acid |
Enzyme Inhibitors Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions Azathioprine Lupus Erythematosus, Systemic Therapeutic Uses Connective Tissue Diseases Antirheumatic Agents |