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

Phase 3

Completed

Conditions: Autoimmune Disease

Interventions: Drug: Enteric-coated Mycophenolate Sodium

Registration Number: NCT00351377

Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 111

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enteric-coated Mycophenolate Sodium	Enteric-coated Mycophenolate Sodium	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.

Primary Outcome Measures

Name	Time	Method
Changes in GI Symptom Severity After Conversion From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)	Baseline and 6 - 8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Changes in the GI Symptom Severity Subscales After Conversion to Enteric-coated Mycophenolate Sodium	Baseline and 6-8 weeks	Changes in GI symptom severity was measured by changes in the total scores of 5 subscales (reflux, diarrhea, constipation, abdominal pain and indigestion) of the Gastrointestinal Symptom Rating Scale (GSRS) from baseline visit to the visit at 6-8 weeks. The GSRS is a 15-item instrument with a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort).
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	Assessed by changes in the Gastrointestinal Quality of Life Index (GIQLI) from Baseline visit to the 6-8 week visit. The GIQLI is a 36-item questionnaire and consists of 5 different subscales. The total score was calculated as the sum of the 36 single items which each ranged from 0-4, leading to a hypothetical range from 0-144 score points (lower scores indicate more unfavorable conditions). The mean change was calculated as (6-8 week visit value) minus (Baseline value).
Changes in the GI-related Quality of Life Subscales After Conversion to Enteric-coated Mycophenolate Sodium	Baseline and 6-8 weeks	The 5 different subscales of the GI-related Quality of Life (GIQLI) were analyzed separately by calculating the average value of the items that were included in the respective subscore. Thus, the theoretical range for each of the subscores was the same as for the single items, i.e. 0-4 score points. An increase in the subscale score indicates an improvement in symptoms.
Changes in Psychological General Well-Being Index (PGWB) After Conversion to Enteric-coated Mycophenolate Sodium	Baseline and 6-8 weeks	The PGWB consists of 22 single items (each ranging from 0-5) with 7 dimensions (including the total score) to be calculated. Lower scores indicate more unfavorable conditions. The total raw score is calculated by summing up all of the single items and thus has a hypothetical range from 0-110 score points. This raw score is further transformed using the formula: (raw score / 110) x 100 to fit a range from 0-100.
Changes in Psychological General Well-Being Index (PGWB) Subscales After Conversion to Enteric-coated Mycophenolate Sodium	Baseline and 6-8 weeks	The change from baseline to the 6-8 week visit for each of the six subscores (each ranging from 0-5) of the PGWB were analyzed individually. Each of the subscores was transformed to fit a range from 0-100. Lower scores indicate more unfavorable conditions, so an increase in score indicates an improvement in symptoms.
Overall Treatment Effects for GI Symptoms Assessed by the Physician	6-8 week	Assessed using the Overall Treatment Effects for GI symptoms questionnaire. The question was: "Has there been any change in the participant's GI symptoms since his/her last study visit? Please indicate if there has been any change in his/her symptoms." The possible answers were: "Improved", "about the same", or "worse. The questionnaire was completed by the physician.
Overall Treatment Effects for GI Symptoms Assessed by the Patient	6-8 week	Assessed using the Overall Treatment Effects for GI symptoms questionnaire. The question was: "Has there been any change in the participant's GI symptoms since his/her last study visit? Please indicate if there has been any change in his/her symptoms." The possible answers were: "Improved", "about the same", or "worse. The questionnaire was completed by the patient.
Overall Treatment Effects for for Health-related Quality of Life Assessed by the Patient	6-8 week	Assessed using the Overall Treatment Effects for health-related quality of life questionnaire. Possible answers were: "Improved", "about the same", or "worse. The questionnaire was completed by the patient.