A randomised controlled trial of Myfortic versus Mycophenolate Mofetil in the treatment of multi-system autoimmune disease. - MYFMAD

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002207-16-GB

Enrollment

Registered

2005-08-16

Start date

2005-09-30

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multi-system autoimmune diseases including vasculitis and systemic lupus erythematosus (SLE)

Interventions

Trade Name: Myfortic Pharmaceutical Form: Coated tablet Trade Name: Cellcept Pharmaceutical Form: Capsule*

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the efficacy and safety of Myfortic versus Mycophenolate Mofetil in the control of disease activity in multi-system autoimmune disease.; Secondary Objective: To evaluate the efficacy and safety of Myfortic in multi-system autoimmune disease. ; 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	—

Measure

Time frame

Main Objective: To compare the efficacy and safety of Myfortic versus Mycophenolate Mofetil in the control of disease activity in multi-system autoimmune disease.; Secondary Objective: To evaluate the efficacy and safety of Myfortic in multi-system autoimmune disease. ; 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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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 7, 2026