Gastrointestinal and Health-Related Quality of Life Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate - Full Text View

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00351377

Purpose

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.

Condition	Intervention	Phase
Autoimmune Disease	Drug: Enteric-coated Mycophenolate sodium (EC-MPS)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Autoimmune Diseases

Drug Information available for: Mycophenolic acid Mycophenolate sodium Mycophenolate mofetil hydrochloride Mycophenolate Mofetil

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	111
Study Start Date:	June 2006
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Enteric-coated Mycophenolate sodium (EC-MPS) Experimental

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351377

Locations

Germany
Novartis Investigational Site
Various cities, Germany

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CERL080ADE08
Study First Received:	July 10, 2006
Last Updated:	June 12, 2009
ClinicalTrials.gov Identifier:	NCT00351377 History of Changes
Health Authority:	Belgium: Institutional Review Board

Keywords provided by Novartis:

Autoimmune disease, mycophenolate, GI problems

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Mycophenolic Acid

Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Mycophenolate mofetil

ClinicalTrials.gov processed this record on November 05, 2009