Measurement and Analysis of Patient Reported Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Patients with Autoimmune Diseases treated with Mycophenolic Acid - MyGiant

• Conditions: patients with autoimmune diseases treated with MPA; MedDRA version: M15Level: LLTClassification code 10061664

• Registration Number: EUCTR2005-002233-12-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified