Myfortic Versus Azathioprine in Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00504244
• Date of registration: 18/07/2007
• Prospective Registration: No
• Primary sponsor: Erasmus Medical Center
• Public title: Myfortic Versus Azathioprine in Systemic Lupus Erythematosus
• Scientific 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.
• Date of first enrolment: July 2007
• Target sample size: 12
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00504244
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Netherlands

Contacts

• Name: Paul LA van Daele, MD, PhD
• Affiliation: Erasmus MC

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: switch to Myfortic

Drug: continuation of azathioprine

Primary Outcome(s)

SLEDAI [Time Frame: 12 months]

Secondary Outcome(s)

BILAG [Time Frame: 12 months]

infections and side effects [Time Frame: 12 months]

renal function [Time Frame: 12 months]

Quality of life (SF36) [Time Frame: 12 months]

Prednisone dose [Time Frame: 12 months]

Secondary ID(s)

CERL080ANL07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novartis Pharmaceuticals