A clinical extension study to evaluate the safety, tolerability and efficacy of AIN457 in multiple sclerosis patients with relapses

• Conditions: relapsing-remitting multiple sclerosis; MedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-001629-25-CZ
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-11
• Last Update Posted: 17 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Was exposed to AIN457 or placebo in study CAIN457B2201 study, up to at and including Visit 10 (Week 24)

Other protocol defined inclusion/exclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified