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Myfortic Versus Azathioprine in Systemic Lupus Erythematosus
This study is currently recruiting participants.
Verified by Erasmus Medical Center, July 2007
First Received: July 18, 2007   No Changes Posted
Sponsors and Collaborators: Erasmus Medical Center
Novartis
Information provided by: Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT00504244
  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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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:


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 ]

Estimated Enrollment: 48
Study Start Date: July 2007
Estimated Study Completion Date: July 2009
  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

Contacts
Contact: Paul L van Daele, MD, PhD +31 10 463 5954 p.l.a.vandaele@erasmusmc.nl
Contact: Martin van Hagen, MD, PhD +31 10 4639222 p.m.vanhagen @erasmusmc.nl

Locations
Netherlands
Erasmus MC Recruiting
Rotterdam, Netherlands, 3015 CE
Sponsors and Collaborators
Erasmus Medical Center
Novartis
Investigators
Principal Investigator: Paul LA van Daele, MD, PhD Erasmus MC
  More Information

Publications:
Allison AC, Eugui EM. Mechanisms of action of mycophenolate mofetil in preventing acute and chronic allograft rejection. Transplantation. 2005 Oct 15;80(2 Suppl):S181-90. Review.
Chan TM, Tse KC, Tang CS, Mok MY, Li FK; Hong Kong Nephrology Study Group. Long-term study of mycophenolate mofetil as continuous induction and maintenance treatment for diffuse proliferative lupus nephritis. J Am Soc Nephrol. 2005 Apr;16(4):1076-84. Epub 2005 Feb 23.
Pisoni CN, Karim Y, Cuadrado MJ. Mycophenolate mofetil and systemic lupus erythematosus: an overview. Lupus. 2005;14 Suppl 1:s9-11. Review.
Bombardier C, Gladman DD, Urowitz MB, Caron D, Chang CH. Derivation of the SLEDAI. A disease activity index for lupus patients. The Committee on Prognosis Studies in SLE. Arthritis Rheum. 1992 Jun;35(6):630-40.
Abu-Shakra M, Lee P. Mortality in systemic sclerosis: a comparison with the general population. J Rheumatol. 1995 Nov;22(11):2100-2.
Boumpas DT, Austin HA 3rd, Fessler BJ, Balow JE, Klippel JH, Lockshin MD. Systemic lupus erythematosus: emerging concepts. Part 1: Renal, neuropsychiatric, cardiovascular, pulmonary, and hematologic disease. Ann Intern Med. 1995 Jun 15;122(12):940-50. Review.
Contreras G, Pardo V, Leclercq B, Lenz O, Tozman E, O'Nan P, Roth D. Sequential therapies for proliferative lupus nephritis. N Engl J Med. 2004 Mar 4;350(10):971-80.
Hay EM, Bacon PA, Gordon C, Isenberg DA, Maddison P, Snaith ML, Symmons DP, Viner N, Zoma A. The BILAG index: a reliable and valid instrument for measuring clinical disease activity in systemic lupus erythematosus. Q J Med. 1993 Jul;86(7):447-58.
Mills JA. Systemic lupus erythematosus. N Engl J Med. 1994 Jun 30;330(26):1871-9. Review. No abstract available.
Stoll T, Stucki G, Malik J, Pyke S, Isenberg DA. Association of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index with measures of disease activity and health status in patients with systemic lupus erythematosus. J Rheumatol. 1997 Feb;24(2):309-13.

Study ID Numbers: CERL080ANL07
Study First Received: July 18, 2007
Last Updated: July 18, 2007
ClinicalTrials.gov Identifier: NCT00504244     History of Changes
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:
SLE
SLEDAI
Azathioprine
Myfortic

Study placed in the following topic categories:
Antimetabolites
Anti-Bacterial Agents
Azathioprine
Autoimmune Diseases
Immunologic Factors
Lupus Erythematosus, Systemic
Lupus
Mycophenolate mofetil
Mycophenolic Acid
Connective Tissue Diseases
Antirheumatic Agents
Immunosuppressive Agents

Additional relevant MeSH terms:
Antimetabolites
Autoimmune Diseases
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Mycophenolic Acid
Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Azathioprine
Lupus Erythematosus, Systemic
Therapeutic Uses
Connective Tissue Diseases
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 11, 2009