Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE)

Atherosclerosis Clinical Trial

— MISSILE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01101802
• Other study ID #: WX18694
• Secondary ID: ISRCTN
• Status: Completed
• Phase: Phase 4
• First received: April 9, 2010
• Last updated: September 27, 2011
• Start date: March 2006
• Est. completion date: October 2008

Study information

• Verified date: May 2005
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: October 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Mycophenolate mofetil
Arm 1 patients were given 1 gm bd mycophenolate mofetil for 8 weeks, The mycophenolate was dispensed as 500mg tablets.
• sugar pill
Arm 2 patients were given 2 sugar pills bd for 8 weeks

Locations

Country	Name	City	State
United Kingdom	Lupus Research Unit, St Thomas' Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	Institute of Child Health, University College London, London, UK.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow mediated dilation	Measure of endothelial function using doppler ultrasound to measure brachial artery dilation in response to increase blood flow.	8 weeks	No
Secondary	BILAG, SLEDAI,	Measurements of disease activity in SLE	8 weeks	No