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

September 27, 2011 updated by: Guy's and St Thomas' NHS Foundation Trust

A Prospective, Randomised, Double-blind, Placebo-controlled Trial Evaluating the Effects of Mycophenolate Mofetil on 'Surrogate Markers' for Atherosclerosis in Female Patients With SLE.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 7EH
        • Lupus Research Unit, St Thomas' Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Sugar pill
Drug: sugar pill
Arm 2 patients were given 2 sugar pills bd for 8 weeks
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 Names:
  • Cellcept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BILAG, SLEDAI,
Time Frame: 8 weeks
Measurements of disease activity in SLE
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

April 9, 2010

First Submitted That Met QC Criteria

April 9, 2010

First Posted (Estimate)

April 12, 2010

Study Record Updates

Last Update Posted (Estimate)

September 28, 2011

Last Update Submitted That Met QC Criteria

September 27, 2011

Last Verified

May 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WX18694
  • ISRCTN (Registry Identifier: ISRCTN11460478)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Systemic Lupus Erythematosus

Clinical Trials on Mycophenolate mofetil

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe