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


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

Primary Outcomes

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

Secondary Outcomes

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: 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

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.