Myfortic Versus Azathioprine in Systemic Lupus Erythematosus

• Status: Terminated
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center
• Collaborator: Novartis Pharmaceuticals
• Treatments: Azathioprine; Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria:

• Males or females, aged 18 years and over

• Patients meeting the diagnostic criteria for SLE (Appendix 2), according to ACR guidelines (including screening for anti-dsDNA (antibody to native DNA in abnormal titer))

• SLEDAI > 6

• Patients treated with maintenance therapy including azathioprine.

• Patients who are willing and able to participate in the study and from whom written informed consent has been obtained

Exclusion Criteria:

• Creatinine clearance of < 20ml/min

• Patients with any clinically significant infection

• Patients with known hypersensitivity to myfortic ® or to drugs with similar chemical structures

• Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin

• Patients with SLE active CNS manifestations or a past history of SLE CNS complications (e.g. psychosis, grand mal seizures)

• Patients who have received prior therapy with mycophenolic acids (MPAs) (e.g. MMF)

• Patients who have received an investigational drug within four weeks prior to study entry

• Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception