Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01433250
First received: August 26, 2011
Last updated: February 16, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention Phase
Multiple Sclerosis
Drug: AIN457
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments [ Time Frame: 97 weeks ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: week 97 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change in volume from start to end of study

  • Measure of Disability: Expanded Disability Status Scale (EDSS). [ Time Frame: Baseline to week 97 ] [ Designated as safety issue: No ]
    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.


Enrollment: 39
Study Start Date: February 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIN 457 Core
(10mg/kg i.v.). AIN 457 core study /AIN 457 Extension
Drug: AIN457
(10mg/kg i.v.).
Other Name: AIN457 core/ AIN extension
Experimental: AIN457 Placebo Core
(10mg/kg i.v.). AIN 457 placebo core study /AIN 457 Extension
Drug: AIN457
(10mg/kg i.v.).
Other Name: AIN Placebo / AIN Extension

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433250

Locations
Czech Republic
Novartis Investigative Site
Hradec Kralove, Czech Republic, 500 05
Novartis Investigative Site
Ostrava-Moravska Ostrava, Czech Republic
Novartis Investigative Site
Ostrava, Czech Republic
Novartis Investigative Site
Praha 2, Czech Republic, 128 08
Novartis Investigative Site
Teplice, Czech Republic, 415 29
Russian Federation
Novartis Investigative Site
Kazan, Russian Federation, 420021
Novartis Investigative Site
Moscow, Russian Federation, 129128
Novartis Investigative Site
Nizhny Novgorod, Russian Federation, 603155
Novartis Investigative Site
Smolensk, Russian Federation, 214019
Ukraine
Novartis Investigative Site
Kharkiv, Ukraine, 61068
Novartis Investigative Site
Kharkiv, Ukraine
Novartis Investigative Site
Kiev, Ukraine
Novartis Investigative Site
Odessa, Ukraine, 65025
Novartis Investigative Site
Vinnitsya, Ukraine, 21005
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01433250     History of Changes
Other Study ID Numbers: CAIN457B2201E1  2011-001629-25 
Study First Received: August 26, 2011
Results First Received: May 28, 2015
Last Updated: February 16, 2016
Health Authority: United States: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation
Ukraine: State Pharmacological Center - Ministry of Health
Czech Republic: State Institute for Drug Control

Keywords provided by Novartis:
Multiple Sclerosis,
demyelinating autoimmune diseases,
interleukin-17,
monoclonal human antibody

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 23, 2016