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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 June 2019 |
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Main ID: |
EUCTR2005-002207-16-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 randomised controlled trial of Myfortic versus Mycophenolate Mofetil in the treatment of multi-system autoimmune disease. - MYFMAD
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Scientific title:
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A randomised controlled trial of Myfortic versus Mycophenolate Mofetil in the treatment of multi-system autoimmune disease. - MYFMAD |
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Date of first enrolment:
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30/09/2005 |
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Target sample size:
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40 |
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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:2005-002207-16 |
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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: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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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:
Inclusion (requires all three)
i) Diagnosis of SLE or PSV
ii) Either: about to commence MMF, or established on MMF for at least three months but with inadequate disease control on MMF 2000mg/day or less
iii) Written informed consent
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) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
b) Exclusion
i) Active infection (including hepatitis B, C, HIV and tuberculosis)
ii) Known hypersensitivity to MMF
iii) cancer or an individual history of cancer (other than resected basal cell skin carcinoma)
iv) Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception
v) Any condition judged by the investigator that would cause the study to be detrimental to the patient
vi) Use of any investigational drug within four weeks of the baseline visit
vii) Patients who are planning to undergo elective surgery during the study period
viii) Age < 18 years
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Multi-system autoimmune diseases including vasculitis and systemic lupus erythematosus (SLE)
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Intervention(s)
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Trade Name: Myfortic
Pharmaceutical Form: Coated tablet
Trade Name: Cellcept
Pharmaceutical Form: Capsule*
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Primary Outcome(s)
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Secondary Objective: To evaluate the efficacy and safety of Myfortic in multi-system autoimmune disease.
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Primary end point(s): a) Primary efficacy: Therapeutic failure: either disease flare or failure to achieve remission at six months (both defined by disease activity scores)
b) Primary tolerability: Inability to tolerate target MMF/Myfortic dose
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Main Objective: To compare the efficacy and safety of Myfortic versus Mycophenolate Mofetil in the control of disease activity in multi-system autoimmune disease.
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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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