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

Novartis Pharmaceuticals111 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

111

Conditions

Autoimmune Disease

Interventions

Enteric-coated Mycophenolate SodiumDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Patients 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). Exclusion criteria: 1. If applicable, GI symptoms assumed or known not to be caused by Mycophenolic acid (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. Current 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. Other protocol-defined inclusion/exclusion criteria may apply

Locations (1)

Novartis Investigational Site

Various Cities, Germany

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 6 - 8 weeks

Secondary Outcomes

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

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).

Time frame: 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

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).

Time frame: Baseline and 6-8 weeks

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

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.

Data from ClinicalTrials.gov

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