Condition category
Musculoskeletal Diseases
Date applied
13/05/2005
Date assigned
13/03/2006
Last edited
17/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr David Jayne

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Addenbrooke's Hospital
Research and Development Department
Box 146
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

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

Publication citations

Additional files

Editorial Notes