Efficacy, Safety and Tolerability of AIN457 in Moderate to Severe Active Crohn's Disease

Phase 2

Terminated

Conditions: Crohn's Disease

Interventions: Drug: Placebo
Drug: AIN457

Registration Number: NCT00584740

Lead Sponsor: Novartis Pharmaceuticals

Brief Summary: This study will assess the safety and efficacy of AIN457 in patients with moderate to severe active Crohn's disease.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 59

Inclusion Criteria

Male or female; 18-75 years old
Diagnosis of Crohn's disease for at least 3 months prior to screening
Confirmation of Crohn's disease by endoscopic or imaging examination
Moderately active Crohn's disease at baseline, defined as:
CDAI ≥220 and ≤450
Active disease despite prior treatment with corticosteroids for at least 2 weeks, or immunosuppressants for at least 3 months. Treatment with azathioprine, 6-MP or MTX is allowed but must have been on a stable dose for at least 10 weeks, corticosteroids are allowed but must have been on a stable doses of prednisolone not exceeding 40 mg for two weeks prior to baseline. Immunosuppressants other than those listed above, such as cyclosporine, tacrolimus and mycophenolate, are not allowed and must be stopped (wash-out periods defined in the protocol);

Exclusion Criteria

Body Mass Index >34
Positive PPD tuberculin skin test or QuantiFeron test
Any subject with evidence of active pulmonary disease or evidence of latent tuberculosis or fungal infection at screening or within past 3 months
Symptoms associated with active bowel structuring disease and pre-stenotic dilation on radiographs
Fistulizing disease if complicated by sepsis and/or untreated abscess
Multiple bowel surgeries and clinically important short bowel syndrome defined as an inability to maintain caloric intake
Use of certain medications as specified in the protocol
Clinical improvement due to other Crohn's therapy

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
AIN457	AIN457	AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Crohns Disease Activity Index (CDAI) Score	6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Remission and/or Response	6 weeks	Remission or response was defined as CDAI \< 150 points or CDAI reduction from baseline of at least 70 points.
Percentage of Participants Achieving Response	6 weeks	Response was defined as CDAI reduction of at least 70 points from baseline.
Mean Change From Baseline in CDAI Score	baseline, 2 weeks, 4 weeks	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.
Percentage of Participants Achieving Remission	6 weeks	Remission was defined as CDAI \< 150 points.
Area Under CDAI Curve	10 weeks	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.
Percentage of Participants Maintaining Remission	10 weeks	Remission was defined as CDAI \< 150 points.