Clinical trial NCT00351377: Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autoimmune Disease
Keywords: Autoimmune disease, mycophenolate, GI problems
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-07-12
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion criteria:

1. Patients 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

Primary outcomes:
measure: Changes in GI Symptom Severity After Conversion From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)
timeFrame: Baseline and 6 - 8 weeks
Secondary outcomes:
measure: Changes in the GI Symptom Severity Subscales After Conversion to Enteric-coated Mycophenolate Sodium
timeFrame: Baseline and 6-8 weeks
measure: Changes in GI-related Quality of Life Index (GIQLI), After Patients Are Converted From MMF to Enteric-coated Mycophenolate Sodium
timeFrame: Baseline and 6-8 weeks
measure: Changes in the GI-related Quality of Life Subscales After Conversion to Enteric-coated Mycophenolate Sodium
timeFrame: Baseline and 6-8 weeks
measure: Changes in Psychological General Well-Being Index (PGWB) After Conversion to Enteric-coated Mycophenolate Sodium
timeFrame: Baseline and 6-8 weeks
measure: Changes in Psychological General Well-Being Index (PGWB) Subscales After Conversion to Enteric-coated Mycophenolate Sodium
timeFrame: Baseline and 6-8 weeks
measure: Overall Treatment Effects for GI Symptoms Assessed by the Physician
timeFrame: 6-8 week
measure: Overall Treatment Effects for GI Symptoms Assessed by the Patient
timeFrame: 6-8 week
measure: Overall Treatment Effects for for Health-related Quality of Life Assessed by the Patient
timeFrame: 6-8 week
Other outcomes:
Locations:
city: Various cities
country: Germany
facility: Novartis Investigational Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: