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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 )

Tracking Information
First Submitted Date  ICMJE August 26, 2011
First Posted Date  ICMJE September 13, 2011
Results First Submitted Date  ICMJE May 28, 2015
Results First Posted Date  ICMJE March 14, 2016
Last Update Posted Date March 14, 2016
Study Start Date  ICMJE February 2012
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2016)
Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments [ Time Frame: 97 weeks ]
Safety outcomes will be described in Adverse events section as there was not an efficacy primary outcome
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2011)
Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments [ Time Frame: up to 1 year ]
Description: number and percentage of subjects with adverse events, number and percentage of subjects with adverse events related to infections, number of abnormalities in vital signs, electrocardiograms, laboratory analysis
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2016)
  • Distribution of Patients With Relapses to End of Study (EOS) (All Subjects) [ Time Frame: week 97 ]
    Description: number of relapses based on neurological assessments and EDSS
  • Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI [ Time Frame: weeks 13,25,37,53,73 and 97 ]
    Measures of absolute number of gadolinium [Gd]-enhancing lesions on T1-weighted scans
  • Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI [ Time Frame: weeks 13,25,37,53,73 and 97 ]
    Measures of absolute number of gadolinium [Gd]-enhancing lesions on T2-weighted lesions
  • Change in Brain Volume at End of Study. [ Time Frame: week 97 ]
    Change in volume from start to end of study
  • Measure of Disability: Expanded Disability Status Scale (EDSS). [ Time Frame: Baseline to week 97 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2011)
  • Measure: relapse rate and disability progression Expanded Disability Status Scale (EDSS). [ Time Frame: up to 1 year ]
    Description: number of relapses based on neurological assessments and EDSS
  • Measure: Assessment of neurodegeneration and neuroinflammation on the brain magnetic resonance imaging. [ Time Frame: over a period of up to 1 year ]
    Brain volume measurement, and measures of absolute number of gadolinium [Gd]-enhancing lesions on T1-weighted scans; new or enlarging lesions on T2-weighted lesions
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis
Official Title  ICMJE An Open Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis
Brief Summary The study will assess the long-term safety and tolerability of AIN457 in patients with relapsing-remitting multiple sclerosis (RRMS). In addition the long-term pattern of maintenance of efficacy and health related quality of life will be explored.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Drug: AIN457
    (10mg/kg i.v.).
    Other Name: AIN457 core/ AIN extension
  • Drug: AIN457
    (10mg/kg i.v.).
    Other Name: AIN Placebo / AIN Extension
Study Arms  ICMJE
  • Experimental: AIN 457 Core
    (10mg/kg i.v.). AIN 457 core study /AIN 457 Extension
    Intervention: Drug: AIN457
  • Experimental: AIN457 Placebo Core
    (10mg/kg i.v.). AIN 457 placebo core study /AIN 457 Extension
    Intervention: Drug: AIN457
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2014)
39
Original Estimated Enrollment  ICMJE
 (submitted: September 9, 2011)
63
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1. Was exposed to AIN457 or placebo in study CAIN457B2201 and completed the CAIN457B2201 study, up to at and including Visit 10 (week 24).

Exclusion Criteria:

  1. Have been treated with:

    • immunosuppressive medications such as azathioprine or methotrexate within 1 month prior to enrollment, if lymphocyte count normal.
    • immunoglobulins and/or monoclonal antibodies (with the exception of AIN457) within 2 month prior to enrollment, or if the immunosuppressive effects are likely to persist at enrollment (such as presence of B cell depletion after rituximab treatment).
  2. Have received total lymphoid irradiation, bone marrow transplantation, alemtuzumab, cladribine, cyclophosphamide, mitoxantrone or other immunosuppressive treatments with long-lasting (over 6 months) or permanent effects.
  3. Have received any live or live attenuated vaccines (including live vaccines for varicella-zoster virus or measles) within 2 months prior to enrollment.
  4. A diagnosis of chronic disease of the immune system other than MS, or of an immunodeficiency syndrome.
  5. Current severe depression.
  6. Pregnant or nursing (lactating) women.
  7. Malignancy diagnosed since enrollment in the core study (except for successfully-treated basal or squamous cell carcinoma of skin).
  8. A new diagnosis of diabetes
  9. Positive testing for tuberculosis (QuantiFeron or chest X-ray).
  10. Subjects with clinically significant cardiac abnormalities
  11. Unable or unwilling to undergo multiple venipunctures
  12. Unable to undergo MRI scans due to newly acquired claustrophobia or metallic implants incompatible with MRI.

Other protocol-defined inclusion/exclusion criteria may apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   Russian Federation,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01433250
Other Study ID Numbers  ICMJE CAIN457B2201E1
2011-001629-25 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date February 2016

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