A randomized, multicenter study to assess the efficacy on disease activity on enteric-coated mycophenolate sodium (EC-MPS, myfortic) versus continuation of azathioprine in patients with systemic lupus erythematosus on azathioprine maintenance therapy.
- Conditions
- lupusSLE10021460
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 48
Systemic lupus on azathioprine
SLEDAI score equal or higher than 6
1. Creatinine clearance of < 20ml/min
2. Patients with any clinically significant infection
3. Patients with known hypersensitivity to myfortic ® or to drugs with similar chemical structures
4. 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
5. Patients with SLE active CNS manifestations or a past history of SLE CNS complications (e.g. psychosis, grand mal seizures)
6. Patients who have received prior therapy with mycophenolic acids (MPAs) (e.g. MMF)
7. Patients who have received an investigational drug within four weeks prior to study entry
8. 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>·Disease activity index measured with SLEDAI</p><br>
- Secondary Outcome Measures
Name Time Method <p>·Disease activity index measured with BILAG (numerical score)<br /><br>·Damage index measured with SLICC/ACR<br /><br>·(Average) daily dose of prednisone. The dose will be measured from the patient<br /><br>starting the study and for the whole duration of the study<br /><br>·Assessment of HRQL using MOS SF-36 (Stoll, et al 1997) </p><br>