Additional identifiers
EudraCT number
2005-002207-16
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
MYFMAD
Study hypothesis
The improved tolerance of Myfortic® when compared to mycophenolate mofetil (MMF) permits higher dosing and improved disease control in multisystem autoimmune disease (MSAID)
Ethics approval
Approved by the Oxfordshire Research Ethics Committee C, reference number: 05/Q1606/140
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Multisystem autoimmune disease
Intervention
Myfortic® tablets versus mycophenolate tablets given to treat multisystem autoimmune disease
Intervention type
Drug
Phase
Not Specified
Drug names
Myfortic, mycophenolate mofetil (MMF)
Primary outcome measure
Primary efficacy:
Therapeutic failure: either disease flare or failure to achieve remission at six months (both defined by disease activity scores)
Primary tolerability:
Inability to tolerate target MMF or Myfortic® dose
Secondary outcome measures
1. Disease activity (British Isles Lupus Assessment Group [BILAG] or Birmingham Vasculitis Assessment Score [BVAS]) area under curve
2. Time to disease remission or time to disease flare
3. Cumulative prednisolone dose
4. All adverse events
5. Severe adverse events
6. Infections
7. Change in 36-item short-form questionnaire (SF-36) between 0 and 6 months and between 0 and 12 months
Overall trial start date
01/09/2005
Overall trial end date
30/09/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Diagnosis of Systemic Lupus Erythematosus (SLE) or Primary Systemic Vasculitis (PSV)
2. Either:
a. About to commence MMF or
b. Established on MMF for at least three months but with inadequate disease control on MMF 2000 mg per day or less
c. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Active infection (including hepatitis B, C, Human Immunodeficiency Virus [HIV] and tuberculosis)
2. Known hypersensitivity to MMF
3. Cancer or an individual history of cancer (other than resected basal cell skin carcinoma)
4. Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception
5. Any condition judged by the investigator that would cause the study to be detrimental to the patient
6. Use of any investigational drug within four weeks of the baseline visit
7. Patients who are planning to undergo elective surgery during the study period
8. Age <18 years
Recruitment start date
01/09/2005
Recruitment end date
30/09/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Vasculitis Department
Cambridge
CB2 2QQ
United Kingdom
Funders
Funder type
Industry
Funder name
Research grant provided by Novartis to investigator own account - vasculitis research account
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in:
Randomized trial of enteric-coated mycophenolate sodium versus mycophenolate mofetil in multi-system autoimmune disease.
Clin Kidney J (2014) doi: 10.1093/ckj/sfu096