Myfortic Versus Azathioprine in Systemic Lupus Erythematosus - Full Text View

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:

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 ] [ 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:

Myfortic 2 dd 720 mg

Other Name: Myfortic

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

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

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:

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.

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.


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 Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Azathioprine Mycophenolate mofetil Mycophenolic Acid Antibiotics, Antineoplastic Antimetabolites Antimetabolites, Antineoplastic	Antineoplastic Agents Antirheumatic Agents Enzyme Inhibitors Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015