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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 April 2019 |
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Main ID: |
EUCTR2005-001688-74-GB |
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Date of registration:
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16/08/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A prospective, randomized, double-blind, placebo controlled trial evaluating the effects of Mycophenolate Mofetil (MMF) on 'surrogate markers' for atherosclerosis in female patients with systemic lupus erythematosus (SLE) - MMF in SLE (Missile)
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Scientific title:
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A prospective, randomized, double-blind, placebo controlled trial evaluating the effects of Mycophenolate Mofetil (MMF) on 'surrogate markers' for atherosclerosis in female patients with systemic lupus erythematosus (SLE) - MMF in SLE (Missile) |
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Date of first enrolment:
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22/09/2005 |
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Target sample size:
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100 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001688-74 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1) Female SLE patients
2) Age 18-50 years
3) Premenopausal using a reliable method of contraception
4) Clinically stable disease
5) Taking hydroxychloroquine and up to 15mgs of prednisolone daily
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1) Smokers
2) Pregnancy or breast feeding
3) Use of other immunosuppressants (hydroxychloroquine and stable dose of prednisolone up to 15 mgs daily will be permitted)
4) Use of any investigational drug within 1 month prior to screening
5) Acute infections 2 weeks prior to Visit 1
6) History of ischaemic heart disease or end stage renal disease
7) Current signs or symptoms of severe, progressive or uncontrolled hepatic, haematological, gastroenterological, endocrine, pulmonary, cardiac or neurological disease.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: no
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Health Condition(s) or Problem(s) studied
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Atherosclerosis in patients with Systemic Lupus Erythematosis
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Intervention(s)
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Trade Name: CellCept
Product Name: Mycophenolate mofetil
Product Code: Ro 106-1443
Pharmaceutical Form: Tablet
INN or Proposed INN: Mycophenolate motetil
CAS Number: Ro 106-1443
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: Confirmation that mycophenolate mofetil is well tolerated in patients with systemic lupus erythematosus.
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Primary end point(s): To assess the effect of treatment with mycophenolate mofetil on endothelium function measured by flow mediated dilation.
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Main Objective: Does Mycophenalote Mofetil, an immunosuppressant, have an effect on the surrogate markers for cardiovascular disease in patients with the autoimmune disease systemic lupus erythematosus?
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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