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Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE) (MISSILE)

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ClinicalTrials.gov Identifier: NCT01101802
Recruitment Status : Completed
First Posted : April 12, 2010
Last Update Posted : September 28, 2011
Sponsor:
Collaborator:
Institute of Child Health, University College London, London, UK.
Information provided by:
Guy's and St Thomas' NHS Foundation Trust

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : March 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Cellcept
Placebo Comparator: Sugar pill Drug: sugar pill
Arm 2 patients were given 2 sugar pills bd for 8 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Flow mediated dilation [ Time Frame: 8 weeks ]
    Measure of endothelial function using doppler ultrasound to measure brachial artery dilation in response to increase blood flow.


Secondary Outcome Measures :
  1. BILAG, SLEDAI, [ Time Frame: 8 weeks ]
    Measurements of disease activity in SLE


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101802


Locations
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United Kingdom
Lupus Research Unit, St Thomas' Hospital
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Institute of Child Health, University College London, London, UK.
Investigators
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Principal Investigator: David P D'Cruz, MD, FRCP Guys and St Thomas' NHS Foundation Trust
More Information
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Responsible Party: Dr David D'Cruz, Lupus Research Unit, St Thomas' hospital
ClinicalTrials.gov Identifier: NCT01101802    
Other Study ID Numbers: WX18694
ISRCTN
First Posted: April 12, 2010    Key Record Dates
Last Update Posted: September 28, 2011
Last Verified: May 2005
Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
SLE
Atherosclerosis
Endothelial function
Mycophenolate mofetil
Additional relevant MeSH terms:
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Atherosclerosis
Lupus Erythematosus, Systemic
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action