Systemic Lupus ErythematosusPhase 4MISSILENCT01101802
Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE)
A Phase 4 study testing Mycophenolate mofetil and sugar pill in people with Systemic Lupus Erythematosus and Atherosclerosis, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Systemic Lupus Erythematosus, Atherosclerosis
- What is being tested?
- Mycophenolate mofetil and sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2006to Oct 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Lupus Research Unit, St Thomas' Hospital
London, SE1 7EH
About this study
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.
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).
- Conditions
- Systemic Lupus Erythematosus, Atherosclerosis
- Being tested
- Mycophenolate mofetil, sugar pill
- Keywords
- SLE, Atherosclerosis, Endothelial function, Mycophenolate mofetil
- Medical subject headings
- Lupus Erythematosus, Systemic, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Cellcept
Arm 1 patients were given 1 gm bd mycophenolate mofetil for 8 weeks, The mycophenolate was dispensed as 500mg tablets.
sugar pillDrug
Arm 2 patients were given 2 sugar pills bd for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mycophenolate mofetil | Active comparator | Patients were given 1gm bd mycophenolate mofetil for 8 weeks Receives: Drug: Mycophenolate mofetil |
| Sugar pill | Placebo comparator | Not described Receives: Drug: sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow mediated dilation
Measure of endothelial function using doppler ultrasound to measure brachial artery dilation in response to increase blood flow.
Measured: 8 weeks
Secondary outcomes (1)
BILAG, SLEDAI,
Measurements of disease activity in SLE
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2010 (estimated)
- Study startMar 2006
- Primary completionMar 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Child Health, University College London, London, UK.
- Investigators
- David P D'Cruz, MD, FRCP, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101802
- Sponsor's protocol ID
- WX18694
- Other IDs
- ISRCTN
- Acronym
- MISSILE
- Status last verified
- May 2005
- First submitted
- 9 Apr 2010
- Last updated
- 28 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01101802
- Acronym / sponsor ID
- MISSILE / WX18694
- Conditions
- Systemic Lupus Erythematosus, Atherosclerosis
- Keywords
- SLE, Atherosclerosis, Endothelial function, Mycophenolate mofetil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Institute of Child Health, University College London, London, UK.
- Study start
- Mar 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 12 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mycophenolate mofetil | Active comparator | Drug: Mycophenolate mofetilPatients were given 1gm bd mycophenolate mofetil for 8 weeks |
| Sugar pill | Placebo comparator | Drug: sugar pill |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mycophenolate mofetilAlso: CellceptArm 1 patients were given 1 gm bd mycophenolate mofetil for 8 weeks, The mycophenolate was dispensed as 500mg tablets. | Drug | Mycophenolate mofetil |
| sugar pillArm 2 patients were given 2 sugar pills bd for 8 weeks | Drug | Sugar pill |
Primary outcome
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.
1 secondary outcome
BILAG, SLEDAI,
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David P D'Cruz, MD, FRCP principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mycophenolate mofetil and sugar pill in people with Systemic Lupus Erythematosus and Atherosclerosis, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow mediated dilation (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2011.