A randomized, multicenter study to assess the efficacy on disease activity on enteric-coated mycophenolate sodium (EC-MPS, myfortic) versus continuation of azathioprine in patients with systemic lupus erythematosus on azathioprine maintenance therapy.

A randomized, multicenter study to assess the efficacy on disease activity on enteric-coated mycophenolate sodium (EC-MPS, myfortic) versus continuation of azathioprine in patients with systemic lupus erythematosus on azathioprine maintenance therapy. - Myfortic versus azathioprine in SLE

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30478

Enrollment

Registered

2007-04-06

Start date

2007-07-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

lupus SLE

Interventions

24 patients will be switched from azathioprine to Myfortic during this study.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Systemic lupus on azathioprine SLEDAI score equal or higher than 6

Exclusion criteria

Exclusion criteria: 1. Creatinine clearance of

Design outcomes

Primary

Measure	Time frame
·Disease activity index measured with SLEDAI	—

Secondary

Measure	Time frame
·Disease activity index measured with BILAG (numerical score) ·Damage index measured with SLICC/ACR ·(Average) daily dose of prednisone. The dose will be measured from the patient starting the study and for the whole duration of the study ·Assessment of HRQL using MOS SF-36 (Stoll, et al 1997)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)