Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase
Response is defined as at least 100 point decrease in CDAI score from baseline. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase
Response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase
Response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase
Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase
Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
CDAI Score at Week 2 of the Induction Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
CDAI Score at Week 4 of the Induction Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
CDAI Score at Week 6 of the Induction Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
CDAI Score at Week 8 in the Randomized Maintenance Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
CDAI Score at Week 10 in the Randomized Maintenance Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
CDAI Score at Week 12 in the Randomized Maintenance Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
CDAI Score at Week 14 in the Randomized Maintenance Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
CDAI Score at Week 16 in the Randomized Maintenance Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
CDAI Score at Week 18 in the Randomized Maintenance Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
CDAI Score at Week 20 in the Randomized Maintenance Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
CDAI Score at Week 22 in the Randomized Maintenance Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
CDAI Score at Week 24 in the Randomized Maintenance Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
CDAI Score at Week 26 in the Randomized Maintenance Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Change From Baseline in CDAI Score at Week 2 of the Induction Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Change From Baseline in CDAI Score at Week 4 of the Induction Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Change From Baseline in CDAI Score at Week 6 of the Induction Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Remission is defined as CDAI score ≤ 150.
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Remission is defined as CDAI score ≤ 150.
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Remission is defined as CDAI score ≤ 150.
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Remission is defined as CDAI score ≤ 150.
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Remission is defined as CDAI score ≤ 150.
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Remission is defined as CDAI score ≤ 150.
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Remission is defined as CDAI score ≤ 150.
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Remission is defined as CDAI score ≤ 150.
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Remission is defined as CDAI score ≤ 150.
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 2 of the Induction Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 4 of the Induction Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 6 of the Induction Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 8 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 10 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 12 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 14 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 16 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 18 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 20 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 22 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 24 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 26 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. Endpoint is the visit when the last observation was taken, either at week 26 or at a visit before in case of early dropout.