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Myfortic Versus Azathioprine in Systemic Lupus Erythematosus

This study has been terminated.
(Insufficient recruitment)
Sponsor:
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
History of Changes
  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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • SLEDAI [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BILAG [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • renal function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Prednisone dose [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life (SF36) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • infections and side effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
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
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
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Pharmacologic Actions
 Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antibiotics, Antineoplastic
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 17, 2013