Clinical trial NCT01433250: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis,
demyelinating autoimmune diseases,
interleukin-17,
monoclonal human antibody
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-09-13
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

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

Primary outcomes:
measure: Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments
timeFrame: 97 weeks
Secondary outcomes:
measure: Distribution of Patients With Relapses to End of Study (EOS) (All Subjects)
timeFrame: week 97
measure: Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI
timeFrame: weeks 13,25,37,53,73 and 97
measure: Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI
timeFrame: weeks 13,25,37,53,73 and 97
measure: Change in Brain Volume at End of Study.
timeFrame: week 97
measure: Measure of Disability: Expanded Disability Status Scale (EDSS).
timeFrame: Baseline to week 97
Other outcomes:
Locations:
city: Hradec Kralove
country: Czech Republic
facility: Novartis Investigative Site
city: Ostrava-Moravska Ostrava
country: Czech Republic
facility: Novartis Investigative Site
city: Ostrava
country: Czech Republic
facility: Novartis Investigative Site
city: Praha 2
country: Czech Republic
facility: Novartis Investigative Site
city: Teplice
country: Czech Republic
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Nizhny Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Smolensk
country: Russian Federation
facility: Novartis Investigative Site
city: Kharkiv
country: Ukraine
facility: Novartis Investigative Site
city: Kharkiv
country: Ukraine
facility: Novartis Investigative Site
city: Kiev
country: Ukraine
facility: Novartis Investigative Site
city: Odessa
country: Ukraine
facility: Novartis Investigative Site
city: Vinnitsya
country: Ukraine
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: