Myfortic Versus Azathioprine in Systemic Lupus Erythematosus

NCT00504244 | Terminated Phase 3

• 1 other identifier: CERL080ANL07
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Systemic Lupus Erythematosus

Keywords

SLE; SLEDAI; Azathioprine; Myfortic

Outcome Measures

Primary Outcomes (1)

• SLEDAI

  12 months

Secondary Outcomes (5)

• BILAG

  12 months

• renal function

  12 months

• Prednisone dose

  12 months

• Quality of life (SF36)

  12 months

• infections and side effects

  12 months

Interventions

switch to Myfortic DRUG

Myfortic 2 dd 720 mg

Also known as: Myfortic

continuation of azathioprine DRUG

Azathioprine 2 mg/kg

Also known as: Azathioprine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Erasmus MC

Rotterdam, 3015 CE, Netherlands

Location

Related Publications (10)

• 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. doi: 10.1097/01.tp.0000186390.10150.66.

  PMID: 16251851 BACKGROUND

• 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. doi: 10.1681/ASN.2004080686. Epub 2005 Feb 23.

  PMID: 15728784 BACKGROUND

• Pisoni CN, Karim Y, Cuadrado MJ. Mycophenolate mofetil and systemic lupus erythematosus: an overview. Lupus. 2005;14 Suppl 1:s9-11. doi: 10.1191/0961203305lu2111oa.

  PMID: 15803925 BACKGROUND

• 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. doi: 10.1002/art.1780350606.

  PMID: 1599520 BACKGROUND

• Abu-Shakra M, Lee P. Mortality in systemic sclerosis: a comparison with the general population. J Rheumatol. 1995 Nov;22(11):2100-2.

  PMID: 8596151 BACKGROUND

• 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. doi: 10.7326/0003-4819-122-12-199506150-00009.

  PMID: 7755231 BACKGROUND

• 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. doi: 10.1056/NEJMoa031855.

  PMID: 14999109 BACKGROUND

• 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.

  PMID: 8210301 BACKGROUND

• Mills JA. Systemic lupus erythematosus. N Engl J Med. 1994 Jun 30;330(26):1871-9. doi: 10.1056/NEJM199406303302608. No abstract available.

  PMID: 8196732 BACKGROUND

• 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.

  PMID: 9034988 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Mycophenolic Acid; Azathioprine

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Thionucleosides; Sulfur Compounds; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Paul LA van Daele, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 18, 2007
• First Posted: July 19, 2007
• Study Start: July 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: November 16, 2010

Record last verified: 2010-11

Locations

NL (1)