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Trial record 5 of 107 for:    ain457

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

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ClinicalTrials.gov Identifier: NCT00584740
Recruitment Status : Terminated (The study was terminated prematurely after futility criterion was met at planned interim analysis of 41 patients.)
First Posted : January 2, 2008
Results First Posted : March 31, 2015
Last Update Posted : March 31, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Crohn's Disease
Interventions Drug: AIN457
Drug: Placebo
Enrollment 59
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AIN457 Placebo
Hide Arm/Group Description AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22. Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
Period Title: Overall Study
Started 39 20
Completed 27 14
Not Completed 12 6
Reason Not Completed
Adverse Event             1             1
Lack of Efficacy             8             2
Withdrawal by Subject             3             2
Lost to Follow-up             0             1
Arm/Group Title AIN457 Placebo Total
Hide Arm/Group Description AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22. Matching placebo to AIN457 was given as an infusion at day 1 and day 22. Total of all reporting groups
Overall Number of Baseline Participants 39 20 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 20 participants 59 participants
37.3  (11.96) 38.3  (14.29) 37.6  (12.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 20 participants 59 participants
Female
15
  38.5%
9
  45.0%
24
  40.7%
Male
24
  61.5%
11
  55.0%
35
  59.3%
1.Primary Outcome
Title Mean Change From Baseline in Crohns Disease Activity Index (CDAI) Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: the safety set included all participants.
Arm/Group Title AIN457 Placebo
Hide Arm/Group Description:
AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
Overall Number of Participants Analyzed 39 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
-29.2  (14.0) -63.1  (13.9)
2.Secondary Outcome
Title Percentage of Participants Achieving Remission and/or Response
Hide Description Remission or response was defined as CDAI < 150 points or CDAI reduction from baseline of at least 70 points.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: the safety set included all participants.
Arm/Group Title AIN457 Placebo
Hide Arm/Group Description:
AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
Overall Number of Participants Analyzed 39 20
Measure Type: Number
Unit of Measure: Percentage of participants
26 65
3.Secondary Outcome
Title Percentage of Participants Achieving Remission
Hide Description Remission was defined as CDAI < 150 points.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: the safety set included all participants.
Arm/Group Title AIN457 Placebo
Hide Arm/Group Description:
AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
Overall Number of Participants Analyzed 39 20
Measure Type: Number
Unit of Measure: Percentage of participants
10 15
4.Secondary Outcome
Title Percentage of Participants Achieving Response
Hide Description Response was defined as CDAI reduction of at least 70 points from baseline.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: the safety set included all participants.
Arm/Group Title AIN457 Placebo
Hide Arm/Group Description:
AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
Overall Number of Participants Analyzed 39 10
Measure Type: Number
Unit of Measure: Percentage of participants
26 65
5.Secondary Outcome
Title Mean Change From Baseline in CDAI Score
Hide Description 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 baseline, 2 weeks, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: the safety set included all participants.
Arm/Group Title AIN457 Placebo
Hide Arm/Group Description:
AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
Overall Number of Participants Analyzed 39 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 2 -15.28  (14.010) -52.85  (13.900)
Week 4 -23.52  (14.010) -58.48  (13.900)
6.Secondary Outcome
Title Area Under CDAI Curve
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: the safety set included all participants.
Arm/Group Title AIN457 Placebo
Hide Arm/Group Description:
AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
Overall Number of Participants Analyzed 39 20
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale*day
11766.26  (594.54) 9723.45  (784.46)
7.Secondary Outcome
Title Percentage of Participants Maintaining Remission
Hide Description Remission was defined as CDAI < 150 points.
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included participants of the safety set who achieved remission.
Arm/Group Title AIN457 Placebo
Hide Arm/Group Description:
AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
Overall Number of Participants Analyzed 4 3
Measure Type: Number
Unit of Measure: Percentage of participants
100 67
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AIN457 Twice 10mg/kg Placebo
Hide Arm/Group Description AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22. Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
All-Cause Mortality
AIN457 Twice 10mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
AIN457 Twice 10mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   7/39 (17.95%)   3/20 (15.00%) 
Blood and lymphatic system disorders     
Leukopenia  1  1/39 (2.56%)  0/20 (0.00%) 
Gastrointestinal disorders     
Aphthous stomatitis  1  1/39 (2.56%)  0/20 (0.00%) 
Crohn's disease  1  5/39 (12.82%)  3/20 (15.00%) 
Oesophagitis  1  1/39 (2.56%)  0/20 (0.00%) 
General disorders     
Disease progression  1  1/39 (2.56%)  0/20 (0.00%) 
Investigations     
C-reactive protein increased  1  1/39 (2.56%)  0/20 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AIN457 Twice 10mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   22/39 (56.41%)   9/20 (45.00%) 
Cardiac disorders     
Cardiac flutter  1  0/39 (0.00%)  1/20 (5.00%) 
Ventricular extrasystoles  1  0/39 (0.00%)  1/20 (5.00%) 
Gastrointestinal disorders     
Abdominal pain  1  5/39 (12.82%)  2/20 (10.00%) 
Crohn's disease  1  3/39 (7.69%)  0/20 (0.00%) 
Diarrhoea  1  2/39 (5.13%)  1/20 (5.00%) 
Dyspepsia  1  0/39 (0.00%)  1/20 (5.00%) 
Frequent bowel movements  1  0/39 (0.00%)  1/20 (5.00%) 
Gastrooesophageal reflux disease  1  0/39 (0.00%)  1/20 (5.00%) 
Nausea  1  2/39 (5.13%)  3/20 (15.00%) 
Vomiting  1  5/39 (12.82%)  1/20 (5.00%) 
General disorders     
Fatigue  1  2/39 (5.13%)  2/20 (10.00%) 
Pain  1  0/39 (0.00%)  1/20 (5.00%) 
Pyrexia  1  2/39 (5.13%)  1/20 (5.00%) 
Infections and infestations     
Candidiasis  1  2/39 (5.13%)  0/20 (0.00%) 
Nasopharyngitis  1  2/39 (5.13%)  0/20 (0.00%) 
Upper respiratory tract infection  1  3/39 (7.69%)  0/20 (0.00%) 
Investigations     
Blood pressure diastolic decreased  1  2/39 (5.13%)  0/20 (0.00%) 
Blood pressure increased  1  0/39 (0.00%)  1/20 (5.00%) 
C-reactive protein increased  1  0/39 (0.00%)  1/20 (5.00%) 
Electrocardiogram QT prolonged  1  2/39 (5.13%)  0/20 (0.00%) 
Red blood cell sedimentation rate increased  1  0/39 (0.00%)  1/20 (5.00%) 
Metabolism and nutrition disorders     
Dehydration  1  2/39 (5.13%)  0/20 (0.00%) 
Hypokalaemia  1  2/39 (5.13%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  4/39 (10.26%)  0/20 (0.00%) 
Myalgia  1  2/39 (5.13%)  0/20 (0.00%) 
Nervous system disorders     
Dizziness  1  1/39 (2.56%)  1/20 (5.00%) 
Headache  1  3/39 (7.69%)  3/20 (15.00%) 
Lethargy  1  0/39 (0.00%)  1/20 (5.00%) 
Psychiatric disorders     
Anxiety  1  0/39 (0.00%)  1/20 (5.00%) 
Insomnia  1  0/39 (0.00%)  2/20 (10.00%) 
Reproductive system and breast disorders     
Prostatitis  1  0/39 (0.00%)  1/20 (5.00%) 
Skin and subcutaneous tissue disorders     
Erythema  1  0/39 (0.00%)  1/20 (5.00%) 
Hyperhidrosis  1  1/39 (2.56%)  1/20 (5.00%) 
Rash  1  1/39 (2.56%)  1/20 (5.00%) 
Vascular disorders     
Hot flush  1  0/39 (0.00%)  1/20 (5.00%) 
Hypertension  1  0/39 (0.00%)  1/20 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00584740    
Other Study ID Numbers: CAIN457A2202
First Submitted: December 21, 2007
First Posted: January 2, 2008
Results First Submitted: January 28, 2015
Results First Posted: March 31, 2015
Last Update Posted: March 31, 2015