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Trial record 3 of 107 for:    ain457

A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01433250
Recruitment Status : Completed
First Posted : September 13, 2011
Results First Posted : March 14, 2016
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Intervention Drug: AIN457
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AIN457 Core / AIN457 Extension AIN Placebo/ AIN457 Extension
Hide Arm/Group Description AIN in core study , continued AIN in extension study ( 10 mg/Kg iv every four weeks)

Placebo in core study and AIN in extension study

(10 mg/kg iv every four weeks)

Period Title: Overall Study
Started 22 17
Completed 19 14
Not Completed 3 3
Reason Not Completed
Protocol Violation             0             1
Withdrawal by Subject             3             2
Arm/Group Title AIN457/ AIN457 Placebo/AIN457 Total
Hide Arm/Group Description AIN in core study , continued AIN in extension study Placebo for core study and AIN in extension study Total of all reporting groups
Overall Number of Baseline Participants 22 17 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 17 participants 39 participants
36.1  (10) 34.2  (8.71) 35.3  (9.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 17 participants 39 participants
Female
12
  54.5%
12
  70.6%
24
  61.5%
Male
10
  45.5%
5
  29.4%
15
  38.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 17 participants 39 participants
Hispanic or Latino
1
   4.5%
0
   0.0%
1
   2.6%
Not Hispanic or Latino
20
  90.9%
16
  94.1%
36
  92.3%
Unknown or Not Reported
1
   4.5%
1
   5.9%
2
   5.1%
1.Primary Outcome
Title Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments
Hide Description Safety outcomes will be described in Adverse events section as there was not an efficacy primary outcome
Time Frame 97 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AIN/AIN PBO/AIN
Hide Arm/Group Description:
AIN core 24 weeks/AIN extension 1 year
placebo first 24 weeks/ AIN extension for 52 weeks
Overall Number of Participants Analyzed 22 17
Measure Type: Number
Unit of Measure: participants
12 8
2.Secondary Outcome
Title Distribution of Patients With Relapses to End of Study (EOS) (All Subjects)
Hide Description Description: number of relapses based on neurological assessments and EDSS
Time Frame week 97
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AIN/AIN PBO/AIN
Hide Arm/Group Description:
AIN core 24 weeks/AIN extension 1 year
placebo first 24 weeks/ AIN extension for 52 weeks
Overall Number of Participants Analyzed 22 17
Measure Type: Number
Unit of Measure: Participants
9 5
3.Secondary Outcome
Title Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI
Hide Description Measures of absolute number of gadolinium [Gd]-enhancing lesions on T1-weighted scans
Time Frame weeks 13,25,37,53,73 and 97
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AIN/AIN PBO/AIN
Hide Arm/Group Description:
AIN core 24 weeks/AIN extension 1 year
placebo first 24 weeks/ AIN extension for 52 weeks
Overall Number of Participants Analyzed 22 17
Mean (Full Range)
Unit of Measure: lesions
week 13 T1 (n=22, 16)
0.8
(0.0 to 4.0)
2.0
(0.0 to 15)
week 25 T1 (n=22, 16)
0.6
(0.0 to 5.0)
1.9
(0 to 20)
week 37 T1 (n=22, 15)
1.0
(0.0 to 5.0)
0.8
(0.0 to 4.0)
week 53 T1 (n=14, 6)
0.3
(0.0 to 3.0)
0.3
(0.0 to 1.0)
wk 73 T1 (n=11,9)
0.6
(0.0 to 3.0)
0.2
(0.0 to 1.0)
EOT (n=15,13)
0.7
(0.0 to 5.0)
0.5
(0.0 to 3.0)
4.Secondary Outcome
Title Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI
Hide Description Measures of absolute number of gadolinium [Gd]-enhancing lesions on T2-weighted lesions
Time Frame weeks 13,25,37,53,73 and 97
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AIN/AIN PBO/AIN
Hide Arm/Group Description:
AIN core 24 weeks/AIN extension 1 year
placebo first 24 weeks/ AIN extension for 52 weeks
Overall Number of Participants Analyzed 22 17
Mean (Full Range)
Unit of Measure: lesions
week 13 T2 (n=22, 16)
1.3
(0.0 to 7.0)
2.2
(0.0 to 12.0)
week 25 T2 (n=22, 16)
0.8
(0.0 to 6.0)
2.4
(0 to 21)
week 37 T2 (n=22, 15)
1.3
(0.0 to 5.0)
1.3
(0.0 to 6.0)
week 53 T2 (n=14, 6)
0.4
(0.0 to 4.0)
0.7
(0.0 to 3.0)
wk 73 T2 (n=11,9)
1.3
(0.0 to 5)
0.9
(0.0 to 5.0)
EOT T2 (n=15,13)
1.1
(0.0 to 4.0)
.07
(0.0 to 3.0)
5.Secondary Outcome
Title Change in Brain Volume at End of Study.
Hide Description Change in volume from start to end of study
Time Frame week 97
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AIN/AIN PBO/AIN
Hide Arm/Group Description:
AIN core 24 weeks/AIN extension 1 year
placebo first 24 weeks/ AIN extension for 52 weeks
Overall Number of Participants Analyzed 22 17
Mean (Standard Deviation)
Unit of Measure: ml
-14.8968  (63.73027) -30.4346  (31.21800)
6.Secondary Outcome
Title Measure of Disability: Expanded Disability Status Scale (EDSS).
Hide Description The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions.
Time Frame Baseline to week 97
Hide Outcome Measure Data
Hide Analysis Population Description
Not all patients may have been available at all time points for EDSS evaluation
Arm/Group Title AIN/AIN PBO/AIN
Hide Arm/Group Description:
AIN core 24 weeks/AIN extension 1 year
placebo first 24 weeks/ AIN extension for 52 weeks
Overall Number of Participants Analyzed 22 17
Measure Type: Number
Unit of Measure: participants
Baseline score 0 1 0
Baseline score 1.0 0 2
Baseline score 1.5 5 5
Baseline score 2.0 5 2
Baseline score 2.5 1 1
Baseline score 3.0 2 4
Baseline score 3.5 2 0
Baseline score 4.0 1 1
Baseline score 4.5 2 2
Baseline score 5.0 1 0
Baseline score 6.0 1 0
WK25 score 0 2 0
WK25 score 1 1 2
WK25 score 1.5 4 5
WK25 score 2.0 4 1
WK25 score 2.5 2 1
WK25 score 3.0 2 4
WK25 score 4.0 1 1
WK25 score 4.5 3 1
WK25 score 5.0 1 0
WK25 score 5.5 0 1
WK25 score 6.0 1 0
WK25 score 6.5 1 0
Safety Week 53 score 0 1 0
Safety Week 53 score 1.0 1 1
Safety Week 53 score 1.5 3 3
Safety Week 53 score 2.0 4 0
Safety Week 53 score 3.0 1 1
Safety Week 53 score 3.5 1 0
Safety Week 53 score 4.0 0 1
Safety Week 53 score 5.0 1 0
Safety Week 53 score 5.5 2 0
Safety Week 53 score 6.0 1 0
WK73 score 0 1 1
WK73 score 1.0 2 1
WK73 score 1.5 1 5
WK73 score 2.0 2 0
WK73 score 3.0 0 1
WK73 score 4.0 1 0
WK73 score 5.5 1 0
WK73 score 6.0 1 0
End of treatment score 0 1 1
End of treatment score1.0 2 1
End of treatment score 1.5 2 5
End of treatment score 2.0 2 1
End of treatment score 2.5 2 1
End of treatment score 3.0 0 3
End of treatment score 3.5 1 0
End of treatment score 4.0 2 0
End of treatment score 4.5 0 1
End of treatment score 5.5 0 1
End of treatment score 6.0 1 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo(Core)/AIN457(Extension) AIN457(Core)/AIN457(Extension)
Hide Arm/Group Description Placebo(core)/AIN457(extension) AIN457(core)/AIN457(extension)
All-Cause Mortality
Placebo(Core)/AIN457(Extension) AIN457(Core)/AIN457(Extension)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo(Core)/AIN457(Extension) AIN457(Core)/AIN457(Extension)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   2/22 (9.09%) 
Injury, poisoning and procedural complications     
Radius fracture  1  0/17 (0.00%)  1/22 (4.55%) 
Musculoskeletal and connective tissue disorders     
Osteochondrosis  1  0/17 (0.00%)  1/22 (4.55%) 
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%
Placebo(Core)/AIN457(Extension) AIN457(Core)/AIN457(Extension)
Affected / at Risk (%) Affected / at Risk (%)
Total   8/17 (47.06%)   7/22 (31.82%) 
Cardiac disorders     
Angina pectoris  1  1/17 (5.88%)  0/22 (0.00%) 
Cardiomyopathy  1  1/17 (5.88%)  0/22 (0.00%) 
Gastrointestinal disorders     
Gastritis  1  1/17 (5.88%)  0/22 (0.00%) 
Infections and infestations     
Cystitis  1  1/17 (5.88%)  0/22 (0.00%) 
Laryngitis  1  1/17 (5.88%)  0/22 (0.00%) 
Nasopharyngitis  1  1/17 (5.88%)  1/22 (4.55%) 
Pharyngitis  1  0/17 (0.00%)  2/22 (9.09%) 
Respiratory tract infection viral  1  1/17 (5.88%)  2/22 (9.09%) 
Rhinitis  1  1/17 (5.88%)  0/22 (0.00%) 
Investigations     
C-reactive protein increased  1  1/17 (5.88%)  0/22 (0.00%) 
Metabolism and nutrition disorders     
Overweight  1  1/17 (5.88%)  0/22 (0.00%) 
Nervous system disorders     
Headache  1  1/17 (5.88%)  0/22 (0.00%) 
Migraine  1  1/17 (5.88%)  0/22 (0.00%) 
Psychiatric disorders     
Anxiety disorder  1  0/17 (0.00%)  2/22 (9.09%) 
Reproductive system and breast disorders     
Uterine cervical erosion  1  1/17 (5.88%)  0/22 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/17 (0.00%)  2/22 (9.09%) 
Vascular disorders     
Hypertension  1  1/17 (5.88%)  0/22 (0.00%) 
Varicose vein  1  0/17 (0.00%)  2/22 (9.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Further development of secukinumab in MS is not being pursued and the extension study , CAIN457B2201E1, further enrollment stopped . Not completing enrollment of this study was not related to the safety or tolerability concerns observed in the study.
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 (ie, data from all sites) in the clinical trial
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01433250    
Other Study ID Numbers: CAIN457B2201E1
2011-001629-25 ( EudraCT Number )
First Submitted: August 26, 2011
First Posted: September 13, 2011
Results First Submitted: May 28, 2015
Results First Posted: March 14, 2016
Last Update Posted: March 14, 2016