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Tracking Information | |||||||||
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First Received Date † | July 18, 2007 | ||||||||
Last Updated Date | July 18, 2007 | ||||||||
Start Date † | July 2007 | ||||||||
Current Primary Outcome Measures † |
SLEDAI [ Time Frame: 12 months ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | Myfortic Versus Azathioprine in Systemic Lupus Erythematosus | ||||||||
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. | ||||||||
Brief Summary | 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. |
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Detailed Description | Systemic lupus erythematosus (SLE) is a complex and potentially life-threatening disease that affects about 40 per 10,000 people in the general population (Mills 1994, Brown & Schrieber 1996). SLE is a chronic inflammatory disease characterized by auto-antibody overproduction and other distinct immunological abnormalities (Boumpas, et al 1995, Mohan & Datta 1995). It may affect the skin, joints, lungs, heart, serous membranes, nervous system or other organs. Improvements in treatment over the last decade have increased 10-year survival rates in Western countries to 90% or more, and 20-year survival rates of nearly 70% have also been reported (Abu-Shakra, et al 1995). Newer treatment strategies include the use of novel immunosuppressive agents, such as mycophenolate mofetil (MMF). MMF has been widely used in solid-organ transplantation (Sollinger 1995, The Tricontinental Mycophenolate Mofetil Renal Transplantation Study Group 1996). MMF also has been used increasingly in autoimmune diseases (e.g., dermatomyositis, primary glomerular disease or psoriasis (Epinette, et al 1987, Gelber, et al 2000, Choi, et al 2002)). MMF is the morpholinoethylester prodrug of mycophenolic acid (MPA). After oral administration MMF is well absorbed and rapidly hydrolyzed to MPA. MPA is a noncompetitive inhibitor of inosine monophosphate (IMP) dehydrogenase (DH). Inhibition of IMPDH leads to the depletion of deoxyguanosine triphosphate and a consequent decrease in the level of substrate required for DNA polymerase activity. This results in inhibition of DNA production and cell proliferation. T and B cells are more dependent on this de novo pathway of purine synthesis because alternative salvage pathways are unavailable. Thus, MPA is a selective inhibitor of lymphocyte proliferation, especially in activated lymphocytes (Allison & Eugui 2000). A limited number of clinical studies have been performed to study the efficacy of MMF in the treatment of SLE. Most of these studies involved the treatment of nephritis. Chan, et al (2000) showed that the combination of MMF and prednisolone is as effective as a regimen of cyclophosphamide and prednisolone followed by azathioprine and prednisolone. Azathioprine and MMF as maintenance therapy were compared to cyclophosphamide therapy (Contreras, et al 2004) and appeared to be more efficacious and safer than long-term therapy with i.v. cyclophosphamide. In this study, it was also noted that patients treated with MMF had received lower doses of corticosteroids during maintenance therapy as compared to patients treated with azathioprine. Recent reports suggest that MMF may also be effective in systemic lupus without severe renal involvement.(Pisoni, et al 2005) Yet, the superiority over azathioprine in this patient group has not been established. Own observations show that approximately 50% of patients with SLE treated with azathioprine have at least some evidence of lupus activity. The aim of this study will be to show a decreased lupus activity in patients treated with myfortic ® compared to therapy with azathioprine. Data so gathered may be useful in planning future developments in this indication This is a 12 months, multi-center, 2-treatment arm, parallel-group, randomized, open label study in patients with systemic lupus erythematosus currently on azathioprine. The patients will be randomized to one of the following two treatment groups:
The final analysis will be performed after the last patient has reached the 12 months of the study. The following efficacy variables will be obtained and recorded:
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Study Phase | Phase III | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
Condition † | Systemic Lupus Erythematosus | ||||||||
Intervention † |
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Study Arms / Comparison Groups | |||||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Enrollment † | 48 | ||||||||
Estimated Completion Date | July 2009 | ||||||||
Primary Completion Date | |||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | Netherlands | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00504244 | ||||||||
Responsible Party | |||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | Erasmus Medical Center | ||||||||
Collaborators †† | Novartis | ||||||||
Investigators † |
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Information Provided By | Erasmus Medical Center | ||||||||
Verification Date | July 2007 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |