A randomised trial of Myfortic® versus mycophenolate in the treatment of multisystem autoimmune disease
| ISRCTN | ISRCTN83027184 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83027184 |
| EudraCT/CTIS number | 2005-002207-16 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/05/2005
- Registration date
- 13/03/2006
- Last edited
- 17/09/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr David Jayne
Scientific
Scientific
Vasculitis Department
Dialysis Unit
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/09/2005 |
| Completion date | 30/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Vasculitis Department
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Addenbrooke's Hospital
Research and Development Department
Box 146
Hills Road
Cambridge
CB2 2QQ
England
United Kingdom
"ROR" |
https://ror.org/04v54gj93 |
|---|
Funders
Funder type
Industry
Research grant provided by Novartis to investigator own account - vasculitis research account
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2014 | Yes | No |
