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Myfortic Versus Azathioprine in Systemic Lupus Erythematosus
This study has been terminated.
(Insufficient recruitment)
Sponsor:
Erasmus Medical Center
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00504244
First received: July 18, 2007
Last updated: November 15, 2010
Last verified: November 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Systemic Lupus Erythematosus | Drug: switch to Myfortic Drug: continuation of azathioprine | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
systemic lupus erythematosus
MedlinePlus related topics:
Lupus
Drug Information available for:
Azathioprine
Mycophenolic acid
Mycophenolate sodium
Azathioprine Sodium
Mycophenolate mofetil hydrochloride
Mycophenolate mofetil
U.S. FDA Resources
Further study details as provided by Erasmus Medical Center:
Primary Outcome Measures:
- SLEDAI [ Time Frame: 12 months ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 12 |
| Study Start Date: | July 2007 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: switch to Myfortic
Myfortic 2 dd 720 mg
Other Name: Myfortic
Drug: continuation of azathioprine
Azathioprine 2 mg/kg
Other Name: Azathioprine
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504244
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504244
Locations
| Netherlands | |
| Erasmus MC | |
| Rotterdam, Netherlands, 3015 CE | |
Sponsors and Collaborators
Erasmus Medical Center
Novartis Pharmaceuticals
Investigators
| Principal Investigator: | Paul LA van Daele, MD, PhD | Erasmus MC |
More Information
Publications:
| Responsible Party: | P.L.A. van Daele, Erasmus MC |
| ClinicalTrials.gov Identifier: | NCT00504244 History of Changes |
| Other Study ID Numbers: |
CERL080ANL07 |
| Study First Received: | July 18, 2007 |
| Last Updated: | November 15, 2010 |
Keywords provided by Erasmus Medical Center:
|
SLE SLEDAI Azathioprine Myfortic |
Additional relevant MeSH terms:
|
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Azathioprine Mycophenolate mofetil Mycophenolic Acid Antimetabolites Molecular Mechanisms of Pharmacological Action |
Antimetabolites, Antineoplastic Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Enzyme Inhibitors Antibiotics, Antineoplastic |
ClinicalTrials.gov processed this record on July 21, 2017