A prospective, randomised, double-blind, placebo-controlled trial evaluating the effects of mycophenolate mofetil (MMF) on surrogate markers for atherosclerosis in female patients with systemic lupus erythematosus
| ISRCTN | ISRCTN57744970 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57744970 |
| ClinicalTrials.gov (NCT) | NCT01101802 |
| Protocol serial number | WX18694 |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust (UK) |
| Funder | Aspreva Pharmaceuticals (UK) (ref: WX18694) |
- Submission date
- 11/01/2006
- Registration date
- 12/04/2006
- Last edited
- 30/09/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr David D'Cruz
Scientific
Scientific
The Lupus Research Unit
The Rayne Institute
Fourth Floor
Lambeth Wing
Lambeth Palace Road
London
SE1 7EH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised double-blind placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A prospective, randomised, double-blind, placebo-controlled trial evaluating the effects of mycophenolate mofetil (MMF) on surrogate markers for atherosclerosis in female patients with systemic lupus erythematosus |
| Study acronym | MISSILE (MMF in SLE) |
| Study objectives | 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(s) | Ethics approval received from the St Thomas' Hospital Research Ethics Committee on the 6th June 2005 (ref: 05/Q0702/63). |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Mycophenolate mofetil (MMF) |
| Primary outcome measure(s) |
To assess the effect of treatment with mycophenolate mofetil on endothelial function, measured by flow-mediated dilation. |
| Key secondary outcome measure(s) |
1. To assess any changes in disease activity measured by SLEDAI and BILAG |
| Completion date | 01/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Female |
| Target sample size at registration | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2006 |
| Date of final enrolment | 01/02/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
The Lupus Research Unit
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 29/09/2019 | 30/09/2019 | No | No |
Additional files
- ISRCTN57744970_BasicResults_29Sept2019.pdf
- uploaded 30/09/2019
Editorial Notes
30/09/2019: The basic results of this trial have been uploaded as an additional file.
26/09/2019: ClinicalTrials.gov number added. No publications found, verifying study status with principal investigator.
