Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE)

Sponsor

Guy's and St Thomas' NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT01101802

Collaborator

Institute of Child Health, University College London, London, UK. (Other)

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Systemic lupus erythematosus (SLE) is an independent risk factor for atherosclerosis. Endothelial dysfunction is the earliest marker of atherosclerosis and is measured by flow mediated dilation (FMD) of the brachial artery. The purpose of the study was to measure FMD in mild, stable SLE patients and look for change in FMD with the immunosuppressant drug mycophenolate mofetil (MMF).

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus Atherosclerosis	Drug: Mycophenolate mofetil Drug: sugar pill	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Prospective, Randomised, Double-blind, Placebo-controlled Trial Evaluating the Effects of Mycophenolate Mofetil on 'Surrogate Markers' for Atherosclerosis in Female Patients With SLE.

Study Start Date :

Mar 1, 2006

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mycophenolate mofetil Patients were given 1gm bd mycophenolate mofetil for 8 weeks	Drug: Mycophenolate mofetil Arm 1 patients were given 1 gm bd mycophenolate mofetil for 8 weeks, The mycophenolate was dispensed as 500mg tablets. Other Names: Cellcept
Placebo Comparator: Sugar pill	Drug: sugar pill Arm 2 patients were given 2 sugar pills bd for 8 weeks

Arm

Intervention/Treatment

Active Comparator: Mycophenolate mofetil

Patients were given 1gm bd mycophenolate mofetil for 8 weeks

Drug: Mycophenolate mofetil

Arm 1 patients were given 1 gm bd mycophenolate mofetil for 8 weeks, The mycophenolate was dispensed as 500mg tablets.

Other Names:

Cellcept

Placebo Comparator: Sugar pill

Drug: sugar pill

Arm 2 patients were given 2 sugar pills bd for 8 weeks

Outcome Measures

Primary Outcome Measures

Flow mediated dilation [8 weeks]
Measure of endothelial function using doppler ultrasound to measure brachial artery dilation in response to increase blood flow.

Secondary Outcome Measures

BILAG, SLEDAI, [8 weeks]
Measurements of disease activity in SLE

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Female SLE patients
Age 18-60 years
If premenopausal using a reliable method of contraception
Clinically stable disease
Taking hydroxychloroquine and up to 15mgs of prednisolone daily

Exclusion Criteria:

Smokers
Pregnancy or breast feeding
Use of other immunosuppressants (hydroxychloroquine and stable dose of prednisolone up to 15 mgs daily will be permitted)
Use of any investigational drug within 1 month prior to screening
Acute infections 2 weeks prior to Visit 1
History of ischaemic heart disease or end stage renal disease
Current signs or symptoms of severe, progressive or uncontrolled hepatic, haematological, gastroenterological, endocrine, pulmonary, cardiac or neurological disease