A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis
This study is currently recruiting participants.
Verified May 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01433250
First received: August 26, 2011
Last updated: May 9, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: AIN457 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Measure: number of subjects with adverse events, number of abnormalities in safety assessments [ Time Frame: up to 1 year ] [ Designated as safety issue: Yes ]Description: number and percentage of subjects with adverse events, number and percentage of subjects with adverse events related to infections, number of abnormalities in vital signs, electrocardiograms, laboratory analysis
Secondary Outcome Measures:
- Measure: relapse rate and disability progression Expanded Disability Status Scale (EDSS). [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]Description: number of relapses based on neurological assessments and EDSS
- Measure: Assessment of neurodegeneration and neuroinflammation on the brain magnetic resonance imaging. [ Time Frame: over a period of up to 1 year ] [ Designated as safety issue: No ]Brain volume measurement, and measures of absolute number of gadolinium [Gd]-enhancing lesions on T1-weighted scans; new or enlarging lesions on T2-weighted lesions
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: AIN457 | Drug: AIN457 |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433250
Contacts
| Contact: Novartis Pharmaceuticals | +41613241111 | Clinical.enquiries@novartis.com |
| Contact: Novartis Pharmaceuticals |
Locations
| Czech Republic | |
| Novartis Investigative Site | Recruiting |
| Hradec Kralove, Czech Republic, 500 05 | |
| Novartis Investigative Site | Not yet recruiting |
| Ostrava, Czech Republic | |
| Novartis Investigative Site | Not yet recruiting |
| Ostrava-Moravska Ostrava, Czech Republic | |
| Novartis Investigative Site | Withdrawn |
| Praha 10, Czech Republic | |
| Novartis Investigative Site | Recruiting |
| Praha 2, Czech Republic, 128 08 | |
| Novartis Investigative Site | Withdrawn |
| Praha 5, Czech Republic, 150 06 | |
| Novartis Investigative Site | Not yet recruiting |
| Teplice, Czech Republic, 415 29 | |
| Russian Federation | |
| Novartis Investigative Site | Not yet recruiting |
| Belgorod, Russian Federation, 308007 | |
| Novartis Investigative Site | Not yet recruiting |
| Kazan, Russian Federation, 420021 | |
| Novartis Investigative Site | Not yet recruiting |
| Moscow, Russian Federation, 129128 | |
| Novartis Investigative Site | Not yet recruiting |
| Nizhny Novgorod, Russian Federation, 603155 | |
| Novartis Investigative Site | Not yet recruiting |
| Smolensk, Russian Federation, 214019 | |
| Novartis Investigative Site | Not yet recruiting |
| St. Petersburg, Russian Federation, 197376 | |
| Novartis Investigative Site | Not yet recruiting |
| Yaroslavl, Russian Federation, 150030 | |
| Ukraine | |
| Novartis Investigative Site | Not yet recruiting |
| Kharkiv, Ukraine, 61068 | |
| Novartis Investigative Site | Not yet recruiting |
| Kharkiv, Ukraine | |
| Novartis Investigative Site | Not yet recruiting |
| Kiev, Ukraine | |
| Novartis Investigative Site | Not yet recruiting |
| Odessa, Ukraine, 65025 | |
| Novartis Investigative Site | Not yet recruiting |
| Vinnitsya, Ukraine, 21005 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01433250 History of Changes |
| Other Study ID Numbers: | CAIN457B2201E1, 2011-001629-25 |
| Study First Received: | August 26, 2011 |
| Last Updated: | May 9, 2013 |
| Health Authority: | United States: Food and Drug Administration Russia: Ministry of Health of the Russian Federation Ukraine: State Pharmacological Center - Ministry of Health Czech Republic: State Institute for Drug Control |
Keywords provided by Novartis:
|
Multiple Sclerosis, demyelinating autoimmune diseases, interleukin-17, monoclonal human antibody |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013