Chron's Disease
Conditions
Brief summary
Sub-study 1 Cohort 1 (Upadacitinib vs Placebo): Proportion of subjects with clinical remission per PROs at Week 52, Sub-study 1 Cohort 1 (Upadacitinib vs Placebo): Proportion of subjects with endoscopic response at Week 52, Sub-study 2: Occurrence rate of subjects with total hospitalizations (all-cause) over time with CD-related hospitalizations over time with surgeries over time with CD-related surgeries over time
Detailed description
Sub-study 1: Proportion of subjects with clinical remission per CDAI at Week 52, Sub-study 1: Proportion of subjects with endoscopic remission at Week 52, Sub-study 1: Change from Baseline in IBDQ at Week 52, Sub-study 1: Proportion of subjects achieving CR-100 at Week 52, Sub-study 1: Proportion of subjects without corticosteroid use for CD at least 90 days prior to Week 52 and achieved clinical remission per PROs at Week 52 (among all subjects), Sub-study 1: Proportion of subjects who discontinued corticosteroid use for CD at least 90 days prior to Week 52 and achieved clinical remission per PROs at Week 52 in subjects taking corticosteroids for CD at Baseline of induction, Sub-study 1: Proportion of subjects with clinical remission per PROs at Week 0 and Week 52, Sub-study 1: Change from Baseline in FACIT-F at Week 52, Sub-study 1: Proportion of subjects with clinical remission per PROs and endoscopic remission at Week 52, Sub-study 1: Proportion of subjects with CD-related hospitalizations during the 52 Week double-blind maintenance period, Sub-study 1: Proportion of subjects with resolution of EIMs at Week 52, in subjects with EIMs at Baseline, Sub-study 2: Proportion of subjects with clinical remission over time, Sub-study 2: Proportion of subjects with enhanced clinical response over time, Sub-study 2: Proportion of subjects with clinical response over time, Sub-study 2: Proportion of subjects with CR-100 over time, Sub-study 2: Proportion of subjects with endoscopic remission at Week 0, and every 48 weeks thereafter, Sub-study 2: Proportion of subjects with endoscopic response at Week 0, and every 48 weeks thereafter, Sub-study 2: Proportion of subjects without corticosteroid use for CD and achieve clinical remission over time, Sub-study 2: Time loss of enhanced clinical response, Sub-study 2: Time loss of clinical remission
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sub-study 1 Cohort 1 (Upadacitinib vs Placebo): Proportion of subjects with clinical remission per PROs at Week 52, Sub-study 1 Cohort 1 (Upadacitinib vs Placebo): Proportion of subjects with endoscopic response at Week 52, Sub-study 2: Occurrence rate of subjects with total hospitalizations (all-cause) over time with CD-related hospitalizations over time with surgeries over time with CD-related surgeries over time | — |
Secondary
| Measure | Time frame |
|---|---|
| Sub-study 1: Proportion of subjects with clinical remission per CDAI at Week 52, Sub-study 1: Proportion of subjects with endoscopic remission at Week 52, Sub-study 1: Change from Baseline in IBDQ at Week 52, Sub-study 1: Proportion of subjects achieving CR-100 at Week 52, Sub-study 1: Proportion of subjects without corticosteroid use for CD at least 90 days prior to Week 52 and achieved clinical remission per PROs at Week 52 (among all subjects), Sub-study 1: Proportion of subjects who discontinued corticosteroid use for CD at least 90 days prior to Week 52 and achieved clinical remission per PROs at Week 52 in subjects taking corticosteroids for CD at Baseline of induction, Sub-study 1: Proportion of subjects with clinical remission per PROs at Week 0 and Week 52, Sub-study 1: Change from Baseline in FACIT-F at Week 52, Sub-study 1: Proportion of subjects with clinical remission per PROs and endoscopic remission at Week 52, Sub-study 1: Proportion of subjects with CD-related hospital | — |
Countries
Austria, Belgium, Croatia, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden