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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AIN457
AIN457
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis,, demyelinating autoimmune diseases,, interleukin-17,, monoclonal human antibody

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

AIN 457 Core

AIN457 Placebo Core

Arm Description

(10mg/kg i.v.). AIN 457 core study /AIN 457 Extension

(10mg/kg i.v.). AIN 457 placebo core study /AIN 457 Extension

Outcomes

Primary Outcome Measures

Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments
Safety outcomes will be described in Adverse events section as there was not an efficacy primary outcome

Secondary Outcome Measures

Distribution of Patients With Relapses to End of Study (EOS) (All Subjects)
Description: number of relapses based on neurological assessments and EDSS
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI
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
Measures of absolute number of gadolinium [Gd]-enhancing lesions on T2-weighted lesions
Change in Brain Volume at End of Study.
Change in volume from start to end of study
Measure of Disability: Expanded Disability Status Scale (EDSS).
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.

Full Information

First Posted
August 26, 2011
Last Updated
February 16, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01433250
Brief Title
A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis
Official Title
An Open Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis,, demyelinating autoimmune diseases,, interleukin-17,, monoclonal human antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AIN 457 Core
Arm Type
Experimental
Arm Description
(10mg/kg i.v.). AIN 457 core study /AIN 457 Extension
Arm Title
AIN457 Placebo Core
Arm Type
Experimental
Arm Description
(10mg/kg i.v.). AIN 457 placebo core study /AIN 457 Extension
Intervention Type
Drug
Intervention Name(s)
AIN457
Other Intervention Name(s)
AIN457 core/ AIN extension
Intervention Description
(10mg/kg i.v.).
Intervention Type
Drug
Intervention Name(s)
AIN457
Other Intervention Name(s)
AIN Placebo / AIN Extension
Intervention Description
(10mg/kg i.v.).
Primary Outcome Measure Information:
Title
Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments
Description
Safety outcomes will be described in Adverse events section as there was not an efficacy primary outcome
Time Frame
97 weeks
Secondary Outcome Measure Information:
Title
Distribution of Patients With Relapses to End of Study (EOS) (All Subjects)
Description
Description: number of relapses based on neurological assessments and EDSS
Time Frame
week 97
Title
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI
Description
Measures of absolute number of gadolinium [Gd]-enhancing lesions on T1-weighted scans
Time Frame
weeks 13,25,37,53,73 and 97
Title
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI
Description
Measures of absolute number of gadolinium [Gd]-enhancing lesions on T2-weighted lesions
Time Frame
weeks 13,25,37,53,73 and 97
Title
Change in Brain Volume at End of Study.
Description
Change in volume from start to end of study
Time Frame
week 97
Title
Measure of Disability: Expanded Disability Status Scale (EDSS).
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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). 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. Have received any live or live attenuated vaccines (including live vaccines for varicella-zoster virus or measles) within 2 months prior to enrollment. A diagnosis of chronic disease of the immune system other than MS, or of an immunodeficiency syndrome. Current severe depression. Pregnant or nursing (lactating) women. Malignancy diagnosed since enrollment in the core study (except for successfully-treated basal or squamous cell carcinoma of skin). A new diagnosis of diabetes Positive testing for tuberculosis (QuantiFeron or chest X-ray). Subjects with clinically significant cardiac abnormalities Unable or unwilling to undergo multiple venipunctures Unable to undergo MRI scans due to newly acquired claustrophobia or metallic implants incompatible with MRI. Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Ostrava-Moravska Ostrava
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Ostrava
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Praha 2
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Teplice
ZIP/Postal Code
415 29
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Kazan
ZIP/Postal Code
420021
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Nizhny Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Kharkiv
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Kiev
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Odessa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Vinnitsya
ZIP/Postal Code
21005
Country
Ukraine

12. IPD Sharing Statement

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

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