Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Percentage of Participants Who Achieved Clinical Remission at Week 24 |
The CDAI score is used to quantify the symptoms of participants with Crohn's Disease (CD). The score ranges from 0 to 600. Clinical remission by CDAI was defined as a score of < 150. A higher score indicates more severe disease. |
Week 24 |
|
| Secondary |
Change From Baseline in Terminal Ileum Segmental Magnetic Resonance Index of Activity (MaRIA) Score at Week 24 |
Magnetic resonance enterography (MRE) is an imaging technique to evaluate disease activity in CD. MaRIA is an MRE-based scoring system. The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and relative contrast enhancement (RCE). A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these components for the terminal ileum segment of the small bowel. A segmental score of = 7 indicates active inflammation and a score of = 11 indicates the presence of an ulcer. Segmental scores less than 7 indicate remission. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Difference in least squared means (Diff in LSM) were from analysis of covariance (ANCOVA) model. A negative change from baseline indicates improvement and a positive change from baseline indicates disease worsening. |
Baseline; Week 24 |
|
| Secondary |
Change From Baseline in Distal Ileum Segmental MaRIA Score at Week 24 |
MRE is an imaging technique to evaluate disease activity in CD. MaRIA is an MRE-based scoring system. The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at Screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the distal ileum segment of the small bowel. A segmental score of = 7 indicates active inflammation and a score of = 11 indicates the presence of an ulcer. Segmental scores less than 7 indicate remission in that segment. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Diff in LSM were from ANCOVA model. A negative change from baseline indicates improvement and a positive change from baseline indicates disease worsening. |
Baseline; Week 24 |
|
| Secondary |
Change From Baseline in Jejunum Segmental MaRIA Score at Week 24 |
MRE is an imaging technique to evaluate disease activity in CD. MaRIA is an MRE-based scoring system.The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at Screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the jejunum segment of the small bowel. A segmental score of = 7 indicates active inflammation and a score of = 11 indicates the presence of an ulcer. Segmental scores less than 7 indicate remission in that segment. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Diff in LSM were from ANCOVA model. A positive change from baseline indicates disease worsening. |
Baseline; Week 24 |
|
| Secondary |
Percentage of Participants Who Achieved MaRIA Remission in Terminal Ileum Segment at Week 24 |
The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the terminal ileum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA remission was defined as a segmental MaRIA score < 7 in terminal ileum segment at Week 24 among participants with MaRIA score = 7 in the same segment at baseline. A segmental score of = 7 indicates active inflammation and a score of = 11 indicates the presence of an ulcer. |
Week 24 |
|
| Secondary |
Percentage of Participants Who Achieved MaRIA Remission in Distal Ileum Segment at Week 24 |
The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the distal ileum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA remission was defined as a segmental MaRIA score < 7 in distal ileum segment at Week 24 among participants with MaRIA score = 7 in the same segment at baseline. A segmental score of = 7 indicates active inflammation and a score of = 11 indicates the presence of an ulcer. |
Week 24 |
|
| Secondary |
Percentage of Participants Who Achieved MaRIA Remission in Jejunum Segment at Week 24 |
The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the jejunum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA remission was defined as a segmental MaRIA score < 7 in jejunum segment at Week 24 among participants with MaRIA score = 7 in the same segment at baseline. A segmental score of = 7 indicates active inflammation and a score of = 11 indicates the presence of an ulcer. |
Week 24 |
|
| Secondary |
Percentage of Participants Who Achieved MaRIA Response in Terminal Ileum Segment at Week 24 |
The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the terminal ileum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA response was defined as a segmental MaRIA score < 11 with baseline score = 11, or a segmental MaRIA score < 7 with baseline score < 11, or = minimum detectable difference (MDD) units decrease from baseline score for segments with baseline MaRIA score = 7 in the terminal ileum. For segments with baseline MaRIA score = 15, the MDD is 6.5 units and for baseline MaRIA score < 15, the MDD is 4.0 units. |
Week 24 |
|
| Secondary |
Percentage of Participants Who Achieved MaRIA Response in Distal Ileum Segment at Week 24 |
The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the distal ileum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA response was defined as a segmental MaRIA score < 11 with baseline score = 11, or a segmental MaRIA score < 7 with baseline score < 11, or = MDD units decrease from baseline score for segments with baseline MaRIA score= 7 in the distal ileum. For segments with baseline MaRIA score = 15, the minimum detectable difference (MDD) is 6.5 units and for baseline MaRIA score < 15, the MDD is 4.0 units. |
Week 24 |
|
| Secondary |
Percentage of Participants Who Achieved MaRIA Response in Jejunum Segment at Week 24 |
The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the jejunum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA response was defined as a segmental MaRIA score < 11 with baseline score = 11, or a segmental MaRIA score < 7 with baseline score < 11, or = MDD units decrease from baseline score for segments with baseline MaRIA score = 7 in the jejunum. For segments with baseline MaRIA score = 15, the MDD is 6.5 units and for baseline MaRIA score < 15, the MDD is 4.0 units. |
Week 24 |
|
| Secondary |
Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Remission at Week 24 |
The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for each of the 3 small bowel segments. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Small bowel MaRIA remission was defined as MaRIA score < 7 at Week 24 in each of the 3 small bowel segments, among participants with MaRIA score = 7 in at least 1 small bowel segment at baseline. |
Week 24 |
|
| Secondary |
Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Response at Week 24 |
The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for each of the 3 small bowel segments. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Participant level small bowel MaRIA response was defined as all small bowel segments with baseline MaRIA score =7 achieve segment level MaRIA response, with no segment level disease worsening in any other segment(s) at Week 24, among participants with MaRIA score = 7 in at least 1 small bowel segment at baseline. |
Week 24 |
|
| Secondary |
Percentage of Participants Who Achieved Early Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10 |
The CDAI score is used to quantify the symptoms of participants with CD. The score ranges from 0 to 600. Clinical remission by CDAI was defined as a score of < 150. A higher score indicates more severe disease. |
Week 10 |
|
| Secondary |
Change From Baseline in CDAI Scores at Week 10 |
The CDAI score is used to quantify the symptoms of participants with CD. The score ranges from 0 to 600. A score of < 150 indicates remission. A higher score indicates more severe disease. Difference in least squared means (Diff in LSM) were from analysis of covariance (ANCOVA) model. A negative change from baseline indicates improvement. |
Baseline; Week 10 |
|
| Secondary |
Change From Baseline in CDAI Scores at Week 24 |
The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. The score ranges from 0 to 600. A score of < 150 indicates remission. A higher score indicates more severe disease. Diff in LSM were from ANCOVA model. A negative change from baseline indicates improvement. |
Baseline; Week 24 |
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