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Clinical Trials/NL-OMON30478
NL-OMON30478
Recruiting
Phase 3

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

Erasmus MC, Universitair Medisch Centrum Rotterdam0 sites48 target enrollmentTBD
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ConditionslupusSLE10021460

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
lupus
Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Enrollment
48
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Systemic lupus on azathioprine
  • •SLEDAI score equal or higher than 6

Exclusion Criteria

  • •1\. Creatinine clearance of \< 20ml/min
  • •2\. Patients with any clinically significant infection
  • •3\. Patients with known hypersensitivity to myfortic ® or to drugs with similar chemical structures
  • •4\. Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
  • •5\. Patients with SLE active CNS manifestations or a past history of SLE CNS complications (e.g. psychosis, grand mal seizures)
  • •6\. Patients who have received prior therapy with mycophenolic acids (MPAs) (e.g. MMF)
  • •7\. Patients who have received an investigational drug within four weeks prior to study entry
  • •8\. females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception

Outcomes

Primary Outcomes

Not specified

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