Crohn's Disease Activity Index (CDAI) Score at Week 2
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Crohn's Disease Activity Index (CDAI) Score at Week 4
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Crohn's Disease Activity Index (CDAI) Score at Week 6
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Percentage of Subjects Who Achieve CDAI Response at Week 2
CDAI Response at Week 2 is defined as clinical response at Week 2 or remission at Week 2. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 2) - (CDAI score at Week 0). Remission is defined as a CDAI score of <= 150 points.
Percentage of Subjects Who Achieve CDAI Response at Week 4
CDAI Response at Week 4 is defined as clinical response at Week 4 or remission at Week 4. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 4) - (CDAI score at Week 0). Remission is defined as a CDAI score of <= 150 points.
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 2
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 4
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 6
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 2
Remission at Week 2 is defined as a CDAI score <= 150 points at Week 2.
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 4
Remission at Week 4 is defined as a CDAI score <= 150 points at Week 4.
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 6
Remission at Week 6 is defined as a CDAI score <= 150 points at Week 6.
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 2
Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 2) - (CDAI score at Week 0).
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 4
Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 4) - (CDAI score at Week 0).
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 6
Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 6) - (CDAI score at Week 0).
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 2
The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 4
The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 6
The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 2
The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life.
There are 4 IBDQ Domain Scores:
Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7)
Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7)
Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 4
The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life.
There are 4 IBDQ Domain Scores:
Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7)
Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7)
Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 6
The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life.
There are 4 IBDQ Domain Scores:
Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7)
Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7)
Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
Concentration of C-reactive Protein (CRP) Value at Week 2
CRP data for subjects receiving rescue medication were excluded.
Concentration of C-reactive Protein (CRP) Value at Week 4
CRP data for subjects receiving rescue medication were excluded.
Concentration of C-reactive Protein (CRP) Value at Week 6
CRP data for subjects receiving rescue medication were excluded.
C-reactive Protein (CRP) Ratio to Baseline at Week 2
CRP data for subjects receiving rescue medication were excluded.
C-reactive Protein (CRP) Ratio to Baseline at Week 4
CRP data for subjects receiving rescue medication were excluded.
C-reactive Protein (CRP) Ratio to Baseline at Week 6
CRP data for subjects receiving rescue medication were excluded.