Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00351377
Other study ID # CERL080ADE08
Secondary ID
Status Completed
Phase Phase 3
First received July 10, 2006
Last updated April 19, 2011
Start date June 2006
Est. completion date June 2009

Study information

Verified date April 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 111
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Germany Novartis Investigational Site Various cities

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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). Baseline and 6-8 weeks No
Secondary 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). Baseline and 6-8 weeks No
Secondary 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. Baseline and 6-8 weeks No
Secondary Changes in Psychological General Well-Being Index (PGWB) After Conversion to Enteric-coated Mycophenolate Sodium 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. Baseline and 6-8 weeks No
Secondary Changes in Psychological General Well-Being Index (PGWB) Subscales After Conversion to Enteric-coated Mycophenolate Sodium 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. Baseline and 6-8 weeks No
Secondary Overall Treatment Effects for GI Symptoms Assessed by the Physician 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. 6-8 week No
Secondary Overall Treatment Effects for GI Symptoms Assessed by the Patient 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. 6-8 week No
Secondary Overall Treatment Effects for for Health-related Quality of Life Assessed by the Patient 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. 6-8 week No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT01934764 - Identification of Correlations Between Reaction to Biotine and Autoimmune Diseases N/A
Recruiting NCT01665196 - 18F-FDG PET/CT for IgG4-Related Disease Early Phase 1
Withdrawn NCT02948855 - Regulation of LncRNA For Breg in Patients With Thymoma and Autoimmune Diseases
Completed NCT01815996 - Identify Clinical Conditions That Increase Circulating DNA Levels
Completed NCT02434458 - Sudoscan in Patients With Autoimmune Disorders N/A
Completed NCT02263703 - Immunogenicity of HPV Vaccine in Immunosuppressed Children Phase 3
Completed NCT00013689 - Pyrimethamine and Sulfadoxine for Treatment of Autoimmune Lymphoproliferative Syndrome Phase 1
Completed NCT00340600 - Continuation of Follow-up of DES-Exposed Cohorts
Not yet recruiting NCT05894707 - Evaluate the Safety and Tolerability of SCT650C in Healthy Volunteers Phase 1
Completed NCT02647866 - Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis Phase 2
Active, not recruiting NCT00716066 - Autologous Stem Cell Transplant for Neurologic Autoimmune Diseases Phase 2
Completed NCT00114530 - Scleroderma: Cyclophosphamide or Transplantation Phase 2/Phase 3
Completed NCT00001630 - Treatment of Autoimmune Thrombocytopenia (AITP) Phase 1
Completed NCT00372177 - The Use of Anti-CD4 Monoclonal Antibody (mAb)-Fragment for the Imaging of Chronic Inflammation in Patients With Active Rheumatoid Arthritis Phase 1/Phase 2
Completed NCT00065390 - Pyrimethamine to Treat Autoimmune Lymphoproliferative Syndrome Phase 1
Completed NCT00001658 - Amoxicillin for the Treatment of Pediatric Autoimmune Disorders Associated With Streptococcal Infections Phase 4
Recruiting NCT03816345 - Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer Phase 1
Completed NCT00001306 - Steroid Therapy in Autoimmune Premature Ovarian Failure N/A
Recruiting NCT03715699 - Leflunomide Treatment for IgG4-RD N/A
Completed NCT02925351 - Fluorine F 18 Clofarabine PET/CT in Imaging Patients With Autoimmune or Inflammatory Diseases Early Phase 1