Phase 2
N=39
A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT01433250 ↗Enrolled (actual)
39
Serious AEs
5.1%
Results posted
Mar 2016
Primary outcome: Primary: Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments — 12; 8 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AIN457 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments |
12; 8 | — |
| SECONDARY Distribution of Patients With Relapses to End of Study (EOS) (All Subjects) |
9; 5 | — |
| SECONDARY Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI |
0.8; 2.0; 0.6; 1.9; 1.0; 0.8 | — |
| SECONDARY Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI |
1.3; 2.2; 0.8; 2.4; 1.3; 1.3 | — |
| SECONDARY Change in Brain Volume at End of Study. |
-14.8968; -30.4346 | — |
| SECONDARY Measure of Disability: Expanded Disability Status Scale (EDSS). |
1; 0; 0; 2; 5; 5 | — |
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
- 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
Data sourced from ClinicalTrials.gov (NCT01433250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.