Colitis Ulcerative, Crohn's disease
Conditions
Brief summary
Number of participants with Crohn's Disease with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), Number of participants with ulcerative colitis with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
Detailed description
Proportion of participants with Crohn's Disease in endoscopic remission based on simple endoscopic score for Crohn’s disease (SES-CD), Proportion of participants with Crohn's Disease in endoscopic remission based on simple endoscopic score for Crohn’s disease (SES-CD), Proportion of participants with Crohn's Disease in clinical remission based on Crohn’s disease activity index (CDAI), Proportion of participants with Crohn's Disease in clinical remission based on Crohn’s disease activity index (CDAI), Proportion of participants with ulcerative colitis in clinical remission based on modified Mayo Score (mMS), Proportion of participants with ulcerative colitis in clinical remission based on modified Mayo Score (mMS)
Interventions
Sponsors
Sanofi-Aventis Recherche & Developpement
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with Crohn's Disease with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), Number of participants with ulcerative colitis with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with Crohn's Disease in endoscopic remission based on simple endoscopic score for Crohn’s disease (SES-CD), Proportion of participants with Crohn's Disease in endoscopic remission based on simple endoscopic score for Crohn’s disease (SES-CD), Proportion of participants with Crohn's Disease in clinical remission based on Crohn’s disease activity index (CDAI), Proportion of participants with Crohn's Disease in clinical remission based on Crohn’s disease activity index (CDAI), Proportion of participants with ulcerative colitis in clinical remission based on modified Mayo Score (mMS), Proportion of participants with ulcerative colitis in clinical remission based on modified Mayo Score (mMS) | — |
Outcome results
None listed