Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE)
NCT ID: NCT01101802
Last Updated: 2011-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
71 participants
INTERVENTIONAL
2006-03-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Mycophenolate mofetil
Patients were given 1gm bd mycophenolate mofetil for 8 weeks
Mycophenolate mofetil
Arm 1 patients were given 1 gm bd mycophenolate mofetil for 8 weeks, The mycophenolate was dispensed as 500mg tablets.
Sugar pill
sugar pill
Arm 2 patients were given 2 sugar pills bd for 8 weeks
Interventions
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Mycophenolate mofetil
Arm 1 patients were given 1 gm bd mycophenolate mofetil for 8 weeks, The mycophenolate was dispensed as 500mg tablets.
sugar pill
Arm 2 patients were given 2 sugar pills bd for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
FEMALE
No
Sponsors
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Institute of Child Health, University College London, London, UK.
UNKNOWN
Guy's and St Thomas' NHS Foundation Trust
OTHER
Responsible Party
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Lupus Research Unit, St Thomas' hospital
Principal Investigators
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David P D'Cruz, MD, FRCP
Role: PRINCIPAL_INVESTIGATOR
Guy's and St Thomas' NHS Foundation Trust
Locations
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Lupus Research Unit, St Thomas' Hospital
London, , United Kingdom
Countries
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Other Identifiers
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ISRCTN
Identifier Type: -
Identifier Source: secondary_id
WX18694
Identifier Type: -
Identifier Source: org_study_id