Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate

NCT00351377 | Completed Phase 3 Results

• 1 other identifier: CERL080ADE08
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Disease

Keywords

Autoimmune disease, mycophenolate, GI problems

Outcome Measures

Primary Outcomes (1)

• Changes in GI Symptom Severity After Conversion From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)

  Changes in GI symptom severity was measured by changes in the Gastrointestinal Symptom Rating Scale (GSRS) total score from baseline visit to the visit at 6-8 weeks. This total score was calculated as the average of the 15 single items (each ranging from 1-7 score points) and thus also had a range from 1-7 score points. Higher values indicate more unfavorable conditions.

  Baseline and 6 - 8 weeks

Secondary Outcomes (8)

• Changes in the GI Symptom Severity Subscales After Conversion to Enteric-coated Mycophenolate Sodium

  Baseline and 6-8 weeks

• Changes in GI-related Quality of Life Index (GIQLI), After Patients Are Converted From MMF to Enteric-coated Mycophenolate Sodium

  Baseline and 6-8 weeks

• Changes in the GI-related Quality of Life Subscales After Conversion to Enteric-coated Mycophenolate Sodium

  Baseline and 6-8 weeks

• Changes in Psychological General Well-Being Index (PGWB) After Conversion to Enteric-coated Mycophenolate Sodium

  Baseline and 6-8 weeks

• Changes in Psychological General Well-Being Index (PGWB) Subscales After Conversion to Enteric-coated Mycophenolate Sodium

  Baseline and 6-8 weeks

Study Arms (1)

Enteric-coated Mycophenolate Sodium

EXPERIMENTAL

Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.

Drug: Enteric-coated Mycophenolate Sodium

Interventions

Enteric-coated Mycophenolate Sodium DRUG

Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily.

Also known as: Myfortic

Enteric-coated Mycophenolate Sodium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigational Site

Various Cities, Germany

Location

MeSH Terms

Conditions

Autoimmune Diseases

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 10, 2006
• First Posted: July 12, 2006
• Study Start: June 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: April 21, 2011
• Results First Posted: January 12, 2011

Record last verified: 2011-04

Locations

DE (1)