Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00351377 | Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate | PHASE3 | COMPLETED | 111 | — | — | Jun 1, 2006 | Jun 1, 2009 | Apr 21, 2011 | 1 | Germany |
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
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 ...