Back to resultsMycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE) (MISSILE)
Primary Purpose
Systemic Lupus Erythematosus, Atherosclerosis
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Mycophenolate mofetil
sugar pill
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring SLE, Atherosclerosis, Endothelial function, Mycophenolate mofetil
Eligibility Criteria
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
Sites / Locations
- Lupus Research Unit, St Thomas' Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Mycophenolate mofetil
Sugar pill
Arm Description
Patients were given 1gm bd mycophenolate mofetil for 8 weeks
Outcomes
Primary Outcome Measures
Flow mediated dilation
Measure of endothelial function using doppler ultrasound to measure brachial artery dilation in response to increase blood flow.
Secondary Outcome Measures
BILAG, SLEDAI,
Measurements of disease activity in SLE
Full Information
NCT ID
NCT01101802
First Posted
April 9, 2010
Last Updated
September 27, 2011
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
Institute of Child Health, University College London, London, UK.
1. Study Identification
Unique Protocol Identification Number
NCT01101802
Brief Title
Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE)
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2005
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
Institute of Child Health, University College London, London, UK.
4. Oversight
Data Monitoring Committee
Yes
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus, Atherosclerosis
Keywords
SLE, Atherosclerosis, Endothelial function, Mycophenolate mofetil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mycophenolate mofetil
Arm Type
Active Comparator
Arm Description
Patients were given 1gm bd mycophenolate mofetil for 8 weeks
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Mycophenolate mofetil
Other Intervention Name(s)
Cellcept
Intervention Description
Arm 1 patients were given 1 gm bd mycophenolate mofetil for 8 weeks, The mycophenolate was dispensed as 500mg tablets.
Intervention Type
Drug
Intervention Name(s)
sugar pill
Intervention Description
Arm 2 patients were given 2 sugar pills bd for 8 weeks
Primary Outcome Measure Information:
Title
Flow mediated dilation
Description
Measure of endothelial function using doppler ultrasound to measure brachial artery dilation in response to increase blood flow.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
BILAG, SLEDAI,
Description
Measurements of disease activity in SLE
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David P D'Cruz, MD, FRCP
Organizational Affiliation
Guys and St Thomas' NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lupus Research Unit, St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE)
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