patients with autoimmune diseases treated with MPA MedDRA version: M15 Level: LLT Classification code 10061664
Conditions
Interventions
Product Name: Myfortic 180 mg Filmtabletten
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Mycophenolate sodium
Current Sponsor code: ERL080
Concentration unit: mg milligram(s)
Concentra
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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); 4. with a medical condition that necessitates MPA-treatment for probably the next 6-8 weeks (time of study duration); 5. eligible and willing to convert to myfortic®; 6. stable on current immunosuppressive regimen; 7. with at least 18 years of age; 8. willing to provide written informed consent; 9. able to meet all study requirements including completing the questionnaires and completing two study visits; 10. receiving drugs that may cause GI symptoms such as biphosphonates, minerals, vitamins, antibiotics or proton pump inhibitors (PPIs) have to be on a stable dose of these substances for at least 1 month prior to enrollment. Patients receiving these drugs 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.). 11. Females capable of becoming pregnant must have a negative pregnancy test within 7 days prior to or at baseline. Pregnancy tests have to be repeated every 4 weeks (see Table 7-1 and chapter 8.2). Females are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. If applicable, GI symptoms assumed or known not to be caused by 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. Undergoing 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; 6. Any other medical condition that, in the opinion of the site investigator based on recall or chart review, would interfere with completing the study, including but not limited to, visual problems or cognitive impairment; 7. Receiving any investigational drug or have received any investigational drug within 30 days prior to study enrollment. 8. Patients with hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolic mofetil or other components of the formulation (e.g. lactose; see also SPCs).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if a switch from MMF to myfortic® results in improved GI- and/or health-related quality of life outcomes, and to determine the proportion of patients with who are experiencing any GI complaints under MMF-based immunosuppressive treatment.;Primary end point(s): Primary endpoint is the comparison of the single answers of the patients to the specified questions in different questionnaires (gastrointestinal specific and quality-of-life specific) before and 6-8 weeks after conversion from MMF to myfortic.;Secondary Objective: • To determine the proportion of patients with autoimmune diseases who are experiencing at least minor GI symptoms under MMF-based immunosuppressive therapy. • To identify and evaluate the impact of immunosuppressive-induced GI symptoms on patient’s perception of symptom severity and HRQL. • To identify specific indications within the broad range of autoimmune diseases in which patients profit most from conversion to myfortic®. • To determine therapeutic efficacy of myfortic® by use of key efficacy parameters. | — |
Countries
Germany
Outcome results
None listed