Ulcerative Colitis
Conditions
Brief summary
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), Incidence and severity of laboratory abnormalities, and change from treatment baseline in laboratory values (hematology, serum chemistry, coagulation, and urinalysis), Incidence of vital sign abnormalities and changes from treatment baseline
Detailed description
The proportion of subjects achieving clinical remission at Weeks 52 and 104, The proportion of subjects achieving clinical remission at Weeks 52 and 104, among subjects achieving clinical remission at study entry, The proportion of subjects achieving clinical response at Weeks 52 and 104, Change from baseline in the Total Mayo Score (TMS) at Weeks 52 and 104, Change from baseline in Partial Mayo Score (PMS) at each of the following weeks: Weeks 52, 104, 156, 208, and 260, The proportion of subjects achieving endoscopic improvement at Weeks 52 and 104
Interventions
Sponsors
Arena Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), Incidence and severity of laboratory abnormalities, and change from treatment baseline in laboratory values (hematology, serum chemistry, coagulation, and urinalysis), Incidence of vital sign abnormalities and changes from treatment baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects achieving clinical remission at Weeks 52 and 104, The proportion of subjects achieving clinical remission at Weeks 52 and 104, among subjects achieving clinical remission at study entry, The proportion of subjects achieving clinical response at Weeks 52 and 104, Change from baseline in the Total Mayo Score (TMS) at Weeks 52 and 104, Change from baseline in Partial Mayo Score (PMS) at each of the following weeks: Weeks 52, 104, 156, 208, and 260, The proportion of subjects achieving endoscopic improvement at Weeks 52 and 104 | — |
Countries
Belgium, Bulgaria, Czechia, Estonia, France, Germany, Hungary, Italy, Lithuania, Poland, Portugal, Romania, Slovakia, Spain
Outcome results
None listed