Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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 h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01433250
Start Date
February 1 2012
End Date
June 1 2014
Last Update
March 14 2016
Active Locations (14)
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1
Novartis Investigative Site
Hradec Králové, Czech Republic, Czechia, 500 05
2
Novartis Investigative Site
Ostrava, Czechia
3
Novartis Investigative Site
Ostrava-Moravska Ostrava, Czechia
4
Novartis Investigative Site
Prague, Czechia, 128 08