Phase 3
N=111
Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate
Autoimmune Disease
Bottom Line
View on ClinicalTrials.gov: NCT00351377 ↗Enrolled (actual)
111
Serious AEs
5.4%
Results posted
Jan 2011
Primary outcome: Primary: Changes in GI Symptom Severity After Conversion From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) — 2.28; 2.02; -0.28 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Enteric-coated Mycophenolate Sodium (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in GI Symptom Severity After Conversion From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) |
2.28; 2.02; -0.28 | — |
| SECONDARY Changes in the GI Symptom Severity Subscales After Conversion to Enteric-coated Mycophenolate Sodium |
-0.24; -0.27; 0.02; -0.51; -0.42 | — |
| SECONDARY Changes in GI-related Quality of Life Index (GIQLI), After Patients Are Converted From MMF to Enteric-coated Mycophenolate Sodium |
100.2; 105.6; 5.8 | — |
| SECONDARY Changes in the GI-related Quality of Life Subscales After Conversion to Enteric-coated Mycophenolate Sodium |
0.18; 0.15; 0.22; 0.10; 0.19 | — |
| SECONDARY Changes in Psychological General Well-Being Index (PGWB) After Conversion to Enteric-coated Mycophenolate Sodium |
65.3; 66.8; 2.0 | — |
| SECONDARY Changes in Psychological General Well-Being Index (PGWB) Subscales After Conversion to Enteric-coated Mycophenolate Sodium |
1.3; 1.5; 0.7; 1.5; 3.4; 2.7 | — |
| SECONDARY Overall Treatment Effects for GI Symptoms Assessed by the Physician |
49; 43; 13; 6 | — |
| SECONDARY Overall Treatment Effects for GI Symptoms Assessed by the Patient |
38; 53; 9; 11 | — |
| SECONDARY Overall Treatment Effects for for Health-related Quality of Life Assessed by the Patient |
31; 61; 10; 9 | — |
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
- 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
Data sourced from ClinicalTrials.gov (NCT00351377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.