Myfortic Versus Azathioprine in Systemic Lupus Erythematosus
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ClinicalTrials.gov Identifier: NCT00504244 |
Recruitment Status :
Terminated
(Insufficient recruitment)
First Posted : July 19, 2007
Last Update Posted : November 16, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Systemic Lupus Erythematosus | Drug: switch to Myfortic Drug: continuation of azathioprine | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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. |
Study Start Date : | July 2007 |
Actual Primary Completion Date : | August 2009 |
Actual Study Completion Date : | August 2009 |

- Drug: switch to Myfortic
Myfortic 2 dd 720 mgOther Name: Myfortic
- Drug: continuation of azathioprine
Azathioprine 2 mg/kgOther Name: Azathioprine
- SLEDAI [ Time Frame: 12 months ]
- BILAG [ Time Frame: 12 months ]
- renal function [ Time Frame: 12 months ]
- Prednisone dose [ Time Frame: 12 months ]
- Quality of life (SF36) [ Time Frame: 12 months ]
- infections and side effects [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00504244
Netherlands | |
Erasmus MC | |
Rotterdam, Netherlands, 3015 CE |
Principal Investigator: | Paul LA van Daele, MD, PhD | Erasmus MC |
Responsible Party: | P.L.A. van Daele, Erasmus MC |
ClinicalTrials.gov Identifier: | NCT00504244 |
Other Study ID Numbers: |
CERL080ANL07 |
First Posted: | July 19, 2007 Key Record Dates |
Last Update Posted: | November 16, 2010 |
Last Verified: | November 2010 |
SLE SLEDAI Azathioprine Myfortic |
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Mycophenolic Acid Azathioprine Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antibiotics, Antineoplastic Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Enzyme Inhibitors |