Condition category
Musculoskeletal Diseases
Date applied
11/01/2006
Date assigned
12/04/2006
Last edited
01/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr David D'Cruz

ORCID ID

Contact details

The Lupus Research Unit
The Rayne Institute
Fourth Floor
Lambeth Wing
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WX18694

Study information

Scientific title

Acronym

MISSILE (MMF in SLE)

Study hypothesis

Systemic lupus erythematosus is a multi-system autoimmune disease that affects approximately 30/100,000 of the United Kingdom population. There is a female preponderance of at least 9:1 and the disease chiefly affects women of childbearing age. Several recent epidemiological studies have shown an increased risk of clinical coronary heart disease in SLE compared to a background population. In particular women in the 35-44 year old age group have a 50-fold increased risk of myocardial infarction. This is leading to a second peak in morbidity and mortality in SLE patients in their fourth and fifth decades, hence the need to find treatments to prevent this accelerated atheroma.

Hypothesis:
MMF will attenuate inflammatory responses by attenuating the production of pro-inflammatory cytokines, inhibiting T-cell number activation, inhibiting adhesion molecule expression, decreasing the production of nitrous oxide (NO) by inducible nitrous oxide systems (NOS) as well as exerting direct anti-proliferation effects on numerous pro-atherogenic cell types. This is expected to be associated with a potent anti-inflammatory effect, which will translate into improvement of endothelial function and attenuation of the pro-inflammatory or oxidant parameters.

Ethics approval

Ethics approval received from the St Thomas' Hospital Research Ethics Committee on the 6th June 2005 (ref: 05/Q0702/63).

Study design

Prospective randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Systemic lupus erythematosus

Intervention

Comparing placebo and control groups of patients before and after eight weeks of taking the study medication. Parameters that will be compared include:
1. Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and British Isles Lupus Assessment Group (BILAG). These are validated scores of disease activity
2. Lupus serology and cardiovascular bio-markers (from fasting blood samples)
3. Ankle-brachial index and pulse wave analysis (non-invasive measurements of arterial stiffness)
4. Flow mediated dilation (non-invasive measurement of endothelium function)

Intervention type

Drug

Phase

Not Specified

Drug names

Mycophenolate mofetil (MMF)

Primary outcome measures

To assess the effect of treatment with mycophenolate mofetil on endothelial function, measured by flow-mediated dilation.

Secondary outcome measures

1. To assess any changes in disease activity measured by SLEDAI and BILAG
2. To measure any changes in lupus serology and bio-markers of cardiovascular disease
3. To measure any changes in arterial stiffness using ankle-brachial index and pulse wave analysis

Overall trial start date

01/02/2006

Overall trial end date

01/02/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female systemic lupus erythematosus (SLE) patients
2. Age 18-50 years
3. Pre-menopausal, using a reliable method of contraception
4. Clinically stable disease
5. Taking hydroxychloroquine, prednisolone up to 15 mg per day or both

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

100

Participant exclusion criteria

1. Smokers
2. Pregnant or breast-feeding
3. Use of other immunosuppressants
4. Use of any investigational drug within one month prior to screening
5. Acute infections two weeks prior to visit
6. History of ischaemic heart disease or end stage renal failure
7. Current signs of severe hepatic, gastrointestinal, endocrine, pulmonary, cardiac or neurological disease

Recruitment start date

01/02/2006

Recruitment end date

01/02/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Lupus Research Unit
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Guy's and St Thomas' NHS Foundation Trust (UK)

Sponsor details

Research and Development
Ground Floor
West Wing
Counting House
Guy's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom

Sponsor type

Industry

Website

http://www.guysandstthomas.nhs.uk/

Funders

Funder type

Industry

Funder name

Aspreva Pharmaceuticals (UK) (ref: WX18694)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes