A randomised trial of Myfortic® versus mycophenolate in the treatment of multisystem autoimmune disease

Completed

• Conditions: Multisystem autoimmune disease; Musculoskeletal Diseases; Autoimmune disease

• Registration Number: ISRCTN83027184
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-13
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Diagnosis of Systemic Lupus Erythematosus (SLE) or Primary Systemic Vasculitis (PSV)
2. Either:
a. About to commence MMF or
b. Established on MMF for at least three months but with inadequate disease control on MMF 2000 mg per day or less
c. Written informed consent

Exclusion Criteria

1. Active infection (including hepatitis B, C, Human Immunodeficiency Virus [HIV] and tuberculosis)
2. Known hypersensitivity to MMF
3. Cancer or an individual history of cancer (other than resected basal cell skin carcinoma)
4. Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception
5. Any condition judged by the investigator that would cause the study to be detrimental to the patient
6. Use of any investigational drug within four weeks of the baseline visit
7. Patients who are planning to undergo elective surgery during the study period
8.Age <18 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified