This study will assess the safety and efficacy of AIN457 in patients with moderate to severe active Crohn's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
59
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Stuttgart, Germany
Mean Change From Baseline in Crohns Disease Activity Index (CDAI) Score
The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to \>=600, where remission of Crohn's disease is defined as CDAI \< 150, and severe disease is defined as CDAI \> 450. A negative change in mean score indicates improvement.
Time frame: 6 weeks
Percentage of Participants Achieving Remission and/or Response
Remission or response was defined as CDAI \< 150 points or CDAI reduction from baseline of at least 70 points.
Time frame: 6 weeks
Percentage of Participants Achieving Remission
Remission was defined as CDAI \< 150 points.
Time frame: 6 weeks
Percentage of Participants Achieving Response
Response was defined as CDAI reduction of at least 70 points from baseline.
Time frame: 6 weeks
Mean Change From Baseline in CDAI Score
The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to \>=600, where remission of Crohn's disease is defined as CDAI \< 150, and severe disease is defined as CDAI \> 450. A negative change in mean score indicates improvement.
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Time frame: baseline, 2 weeks, 4 weeks
Area Under CDAI Curve
The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to \>=600, where remission of Crohn's disease is defined as CDAI \< 150, and severe disease is defined as CDAI \> 450. An area under the CDAI response curve analysis was performed with a starting point from week 4.
Time frame: 10 weeks
Percentage of Participants Maintaining Remission
Remission was defined as CDAI \< 150 points.
Time frame: 10 weeks