Status:
COMPLETED
Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Autoimmune Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will 1) determine the proportion of patients with a...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with autoimmune diseases;
- receiving immunosuppressive therapy that includes MMF at time of study enrollment;
- receiving immunosuppressive regimen that includes MMF at a stable dose for at least 1 month prior to enrollment. Patients can only be enrolled into the study if it is expected that treatment will continue at the same dose until study end (6-8 weeks after enrollment).
- Exclusion criteria:
- If applicable, GI symptoms assumed or known not to be caused by Mycophenolic acid (MPA) therapy (e.g. oral biphosphonates induced, infectious diarrhea);
- Women of child-bearing potential who are planning to become pregnant or are pregnant and/or lactating or who are unwilling to use effective means of contraception;
- Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements;
- Current acute medical intervention or hospitalization;
- Presence of a medical condition not related to a GI event at time of visit, which requires immediate medical intervention.
- Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT00351377
Start Date
June 1 2006
End Date
June 1 2009
Last Update
April 21 2011
Active Locations (1)
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1
Novartis Investigational Site
Various Cities, Germany