Overview

This trial is active, not recruiting.

Condition multiple sclerosis
Treatment ain457
Phase phase 2
Sponsor Novartis Pharmaceuticals
Start date February 2012
End date May 2014
Trial size 39 participants
Trial identifier NCT01433250, 2011-001629-25, CAIN457B2201E1

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ain457

Primary Outcomes

Measure
Measure: number of subjects with adverse events, number of abnormalities in safety assessments
time frame: up to 1 year

Secondary Outcomes

Measure
Measure: relapse rate and disability progression Expanded Disability Status Scale (EDSS).
time frame: up to 1 year
Measure: Assessment of neurodegeneration and neuroinflammation on the brain magnetic resonance imaging.
time frame: over a period of up to 1 year

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria

  • 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

Additional Information

Official title A 1-year Open Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Novartis.