Mucosal Healing Study in Crohn's Disease (CD)

The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation, thus a negative change from Baseline (i.e., Week 10 score minus Baseline score) indicates improvement.

Time frame: Baseline, Week 10

Population: Of the 89 patients in the Intent to Treat Population, 44 patients were in the subpopulation with a blinded assessment at Week 10 and Baseline, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.

The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation, thus a negative change from Baseline (i.e., Week 10 score minus Baseline score) indicates improvement.

Time frame: Baseline, Week 10

Population: Of the 89 patients in the Intent to Treat Population, 78 patients had data at both Baseline and Week 10, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.

Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Time frame: Baseline, Week 10

Population: Of the 89 patients in the Intent to Treat Population, 73 patients had data at both Baseline and Week 10, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.

Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Time frame: Baseline, Week 54

Population: Of the 89 patients in the Intent to Treat Population, 39 had CDAI scores at Week 54 and Baseline and are included in this summary. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.

The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.

Time frame: Baseline, Week 54

Population: Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.

The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.

Time frame: Baseline, Week 54

Population: Of the 89 patients in the Intent to Treat Population, 52 had a CDEIS score at Week 54 and at Baseline and are included here. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.

The histological Crohn's disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease.

Time frame: Baseline, Week 10

Population: Of the 89 patients in the Intent to Treat Population, 75 patients had data at Week 10 and at Baseline for the blinded assessment, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative change from Baseline indicates improvement.

The histological Crohn's disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease.

Time frame: Baseline, Week 54

Population: Of the 89 patients in the Intent to Treat Population, 52 patients had data at Week 54 and at Baseline for blinded assessment, and are included in this summary. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.

Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Time frame: Week 10

Population: Of the 89 patients in the Intent to Treat Population, 73 patients had plasma level data and a CDAI score at Week 10 and are included in this summary.

The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.

Time frame: Week 10

Population: Of the 89 patients in the Intent to Treat Population, 51 patients were in the subpopulation with a blinded assessment at Week 10. 48 patients had both CDEIS and CRP data at Week 10.

The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.

Time frame: Week 10

Population: Of the 89 patients in the Intent to Treat Population, 76 patients had plasma level data and a CDEIS score at Week 10 and are included in this summary.

The histological Crohn's disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease

Time frame: Week 10

Population: Of the 89 patients in the Intent to Treat Population, 72 patients had plasma data and histological Crohn's disease score assessment at Week 10, and are included in this summary.

Time frame: Week 10

Population: Of the 89 patients in the Intent to Treat Population, 76 patients had plasma level data at Week 10 and are included in this summary.

Time frame: Week 52

Population: Of the 89 patients in the Intent to Treat Population, 51 patients had plasma level data at Week 54 and are included in this summary.

Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Time frame: Week 10

Population: The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as remitters. Percentage is calculated by dividing the number of patients with a CDAI less than or equal to 150 points at Week 10 by the total number of patients in the Intent to Treat Population, multiplied by 100.

Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Time frame: Week 54

Population: The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as remitters. Percentage is calculated by dividing the number of patients with a CDAI less than or equal to 150 points at Week 54 by the total number of patients in the Intent to Treat Population, multiplied by 100.

Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Time frame: Baseline, Week 10

Population: The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as non-responders. Percentage is calculated by dividing the number of patients with a CDAI decrease of at least 100 points at Week 10 by the total number of patients in the Intent to Treat Population, multiplied by 100.

Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Time frame: Baseline, Week 54

Population: The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as non-responders. Percentage is calculated by dividing the number of patients with a CDAI decrease of at least 100 points at Week 54 by the total number of patients in the Intent to Treat Population, multiplied by 100.

Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score

Time frame: Week 10

Population: Of the 89 patients in the Intent to Treat Population, 51 patients were in the subpopulation who had a blinded assessment at Week 10 and are included here. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 10 by the total number of patients with data collected, multiplied by 100.

Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score

Time frame: Week 10

Population: Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 10 by the total number of patients with data collected, multiplied by 100.

Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score

Time frame: Week 54

Population: Of the 89 patients in the Intent to Treat Population, 33 patients were in the subpopulation who had a blinded assessment at Week 54 and are included here. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 54 by the total number of patients with data collected, multiplied by 100.

Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score

Time frame: Week 54

Population: Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 54 by the total number of patients with data collected, multiplied by 100.

The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.

Time frame: Week 10

Population: Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and Baseline, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score \<3 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.

The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.

Time frame: Week 10

Population: Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score \<3 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.

The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.

Time frame: Week 54

Population: Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number of patients with a CDEIS score \<3 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.

The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.

Time frame: Week 54

Population: Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score \<3 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.

The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.

Time frame: Week 10

Population: Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and Baseline, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score \<6 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.

The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.

Time frame: Week 10

Population: Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score \<6 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.

The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.

Time frame: Week 54

Population: Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number of patients with a CDEIS score \<6 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.

The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.

Time frame: Week 54

Population: Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score \<6 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.

The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.

Time frame: Baseline, Week 10

Population: Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and at Baseline, and are included here. Percentage patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 10 by the number of patients with CDEIS data at Baseline and Week 10, multiplied by 100.

The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.

Time frame: Baseline, Week 10

Population: Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10 and at Baseline, and are included here. Percentage of patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 10 by the number of patients with CDEIS data at both Baseline and Week 10, multiplied by 100.

The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.

Time frame: Baseline, Week 54

Population: Of 89 patients in the Intent to Treat Population 28 had matching nonblinded/blinded assessments and are in the subpopulation with blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number patients with CDEIS decrease of at least 5 points at Week 54 by the number with CDEIS at Baseline and Week 54, multiplied by 100

The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.

Time frame: Baseline, Week 54

Population: Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54 and at Baseline, and are included here. Percentage of patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 54 by the number of patients with CDEIS data at both Baseline and Week 54, multiplied by 100.

Ratio is calculated as the Week 10 value divided by the Baseline value for patients with data at both timepoints.

Time frame: Baseline, Week 10

Population: Of the 89 patients in the Intent to Treat Population, 76 patients had plasma levels taken at Week 10 and Baseline and are included in this summary. Ratio is calculated as the Week 10 value divided by the Baseline value for patients with data at both timepoints.

The ratio is calculated as the Week 52 value divided by Baseline value for patients with data at both timepoints.

Time frame: Baseline, Week 52

Population: Of the 89 patients in the Intent to Treat Population, 51 patients had plasma level data at Week 54 and Baseline and are included in this summary. Ratio was calculated by dividing the Week 54 value by the Baseline value for the patients with data at both timepoints.