Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE)

This study has been completed.
Sponsor:
Collaborator:
Institute of Child Health, University College London, London, UK.
Information provided by:
Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01101802
First received: April 9, 2010
Last updated: September 27, 2011
Last verified: May 2005
  Purpose

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 Intervention Phase
Systemic Lupus Erythematosus
Atherosclerosis
Drug: Mycophenolate mofetil
Drug: sugar pill
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Guy's and St Thomas' NHS Foundation Trust:

Primary Outcome Measures:
  • Flow mediated dilation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Measure of endothelial function using doppler ultrasound to measure brachial artery dilation in response to increase blood flow.


Secondary Outcome Measures:
  • BILAG, SLEDAI, [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Measurements of disease activity in SLE


Enrollment: 71
Study Start Date: March 2006
Study Completion Date: October 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101802

Locations
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
Principal Investigator: David P D'Cruz, MD, FRCP Guys and St Thomas' NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Dr David D'Cruz, Lupus Research Unit, St Thomas' hospital
ClinicalTrials.gov Identifier: NCT01101802     History of Changes
Other Study ID Numbers: WX18694, ISRCTN
Study First Received: April 9, 2010
Last Updated: September 27, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
SLE
Atherosclerosis
Endothelial function
Mycophenolate mofetil

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Lupus Erythematosus, Systemic
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Mycophenolate mofetil
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014