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

This study has been terminated.
(The study was terminated prematurely after futility criterion was met at planned interim analysis of 41 patients.)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00584740
First received: December 21, 2007
Last updated: March 24, 2015
Last verified: March 2015

December 21, 2007
March 24, 2015
August 2008
August 2010   (final data collection date for primary outcome measure)
Mean Change From Baseline in Crohns Disease Activity Index (CDAI) Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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.
Mean Crohn's Disease Activity Index (CDAI) [ Time Frame: At 6 weeks ]
Complete list of historical versions of study NCT00584740 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Achieving Remission and/or Response [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Remission or response was defined as CDAI < 150 points or CDAI reduction from baseline of at least 70 points.
  • Percentage of Participants Achieving Remission [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Remission was defined as CDAI < 150 points.
  • Percentage of Participants Achieving Response [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Response was defined as CDAI reduction of at least 70 points from baseline.
  • Mean Change From Baseline in CDAI Score [ Time Frame: baseline, 2 weeks, 4 weeks ] [ Designated as safety issue: No ]
    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.
  • Area Under CDAI Curve [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Remission was defined as CDAI < 150 points.
- % of subjects achieving remission and/or response (CDAI <150) or a decrease of at least 70 points from baseline - Mean CDAI at 2 and 4 weeks - Maintenance of remission and/or response - Safety/tolerability
Not Provided
Not Provided
 
Efficacy, Safety and Tolerability of AIN457 in Moderate to Severe Active Crohn's Disease
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Proof-of-concept Study to Assess the Efficacy, Safety and Tolerability of Two Single iv Infusions of AIN457 10 mg/kg (Anti IL-17 Monoclonal Antibody) in Patients With Moderate to Severe Active Crohn's Disease

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Crohn's Disease
  • Drug: AIN457
    10 mg/kg
  • Drug: Placebo
    Matching placebo to AIN457
  • Experimental: AIN457
    AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
    Intervention: Drug: AIN457
  • Placebo Comparator: Placebo
    Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
59
August 2010
August 2010   (final data collection date for primary outcome measure)

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

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00584740
CAIN457A2202
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Principal Investigator: NOVARTIS Novartis investigator site
Novartis
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP