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Completed

NCT Number: NCT01101802

Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE)

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).

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Key information

Conditions

Systemic Lupus Erythematosus Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Autoimmune Diseases Cardiovascular Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Lupus Research Unit, St Thomas' Hospital

London, SE1 7EH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mycophenolate mofetil

Drug

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

Other names: Cellcept

Sugar pill

Drug

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

Primary outcomes

  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 outcomes

  1. BILAG, SLEDAI,

    Time frame: 8 weeks

    Measurements of disease activity in SLE

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Collaborators

  • Institute of Child Health, University College London, London, UK.

Registry information

Official study 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.

Acronym: MISSILE

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 12, 2010
Registry last updated
Sep 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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