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Gastrointestinal and Health-Related Quality of Life Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate
This study has been completed.
Study NCT00351377   Information provided by Novartis
First Received: July 10, 2006   Last Updated: June 12, 2009   History of Changes

July 10, 2006
June 12, 2009
June 2006
June 2009   (final data collection date for primary outcome measure)
Changes in GI symptom severity after conversion from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium; week 0, 6-8, 6-12 (optional follow-up visit) [ Designated as safety issue: No ]
Changes in GI symptom severity after conversion from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium; week 0, 6-8, 6-12 (optional follow-up visit)
Complete list of historical versions of study NCT00351377 on ClinicalTrials.gov Archive Site
  • proportion of patients who are experiencing at least minor GI symptoms under MMF-based immunosuppressive therapy; week 0, 6-8 weeks, and 6-12 weeks (optional follow-up visit) [ Designated as safety issue: No ]
  • changes in health related quality of life, and impact of immunosuppressive-induced GI symptoms; week 0, 6-8 weeks, and 6-12 weeks (optional follow-up visit) [ Designated as safety issue: No ]
  • therapeutic efficacy; week 0, 6-8 weeks, and 6-12 weeks (optional follow-up visit) [ Designated as safety issue: No ]
  • identification of specific indications within the broad range of autoimmune diseases in which patients profit most from conversion to enteric-coated mycophenolate sodium; week 0, 6-8 weeks, 6-12 weeks (optional follow-up visit) [ Designated as safety issue: No ]
  • proportion of patients who are experiencing at least minor GI symptoms under MMF-based immunosuppressive therapy; week 0, 6-8 weeks, and 6-12 weeks (optional follow-up visit)
  • changes in health related quality of life, and impact of immunosuppressive-induced GI symptoms; week 0, 6-8 weeks, and 6-12 weeks (optional follow-up visit)
  • therapeutic efficacy; week 0, 6-8 weeks, and 6-12 weeks (optional follow-up visit)
  • identification of specific indications within the broad range of autoimmune diseases in which patients profit most from conversion to enteric-coated mycophenolate sodium; week 0, 6-8 weeks, 6-12 weeks (optional follow-up visit)
 
Gastrointestinal and Health-Related Quality of Life Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate
Measurement and Analysis of Patient Reported Gastrointestinal (GI) and Health-Related Quality of Life (HRQL) Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate (MPA)

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 autoimmune diseases who are experiencing any GI complaints under MMF-based immunosuppressive treatment and 2) assess if a switch from MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or health-related quality of life outcomes.

 
Phase III
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Autoimmune Disease
Drug: Enteric-coated Mycophenolate sodium (EC-MPS)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
111
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion criteria Patients

  1. with autoimmune diseases;
  2. receiving immunosuppressive therapy that includes MMF at time of study enrollment;
  3. 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

  1. If applicable, GI symptoms assumed or known not to be caused by Mycophenolic acid (MPA) therapy (e.g. oral biphosphonates induced, infectious diarrhea);
  2. 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;
  3. Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements;
  4. Current acute medical intervention or hospitalization;
  5. 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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00351377
External Affairs, Novartis Pharmaceuticals
CERL080ADE08
Novartis Pharmaceuticals
 
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP