A randomised trial of Myfortic® versus mycophenolate in the treatment of multisystem autoimmune disease

ISRCTN	ISRCTN83027184
DOI	https://doi.org/10.1186/ISRCTN83027184
Clinical Trials Information System (CTIS)	2005-002207-16
Protocol serial number	N/A
Sponsor	Cambridge University Hospitals NHS Foundation Trust (UK)
Funder	Research grant provided by Novartis to investigator own account - vasculitis research account

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr David Jayne
Scientific

Vasculitis Department
Dialysis Unit
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	MYFMAD
Study objectives	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(s)	Approved by the Oxfordshire Research Ethics Committee C, reference number: 05/Q1606/140
Health condition(s) or problem(s) studied	Multisystem autoimmune disease
Intervention	Myfortic® tablets versus mycophenolate tablets given to treat multisystem autoimmune disease
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Myfortic, mycophenolate mofetil (MMF)
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	30/09/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	40
Key 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
Key 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
Date of first enrolment	01/09/2005
Date of final enrolment	30/09/2006

Vasculitis Department

Cambridge
CB2 2QQ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2014		Yes	No