A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

An Open Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01433250
• Other study ID #: CAIN457B2201E1
• Secondary ID: 2011-001629-25
• Status: Completed
• Phase: Phase 2
• First received: August 26, 2011
• Last updated: February 16, 2016
• Start date: February 2012
• Est. completion date: June 2014

Study information

• Verified date: February 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationRussia: Ministry of Health of the Russian FederationUkraine: State Pharmacological Center - Ministry of HealthCzech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• AIN457
(10mg/kg i.v.).
• AIN457
(10mg/kg i.v.).

Locations

Country	Name	City	State
Czech Republic	Novartis Investigative Site	Hradec Kralove
Czech Republic	Novartis Investigative Site	Ostrava
Czech Republic	Novartis Investigative Site	Ostrava-Moravska Ostrava
Czech Republic	Novartis Investigative Site	Praha 2
Czech Republic	Novartis Investigative Site	Teplice
Russian Federation	Novartis Investigative Site	Kazan
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Nizhny Novgorod
Russian Federation	Novartis Investigative Site	Smolensk
Ukraine	Novartis Investigative Site	Kharkiv
Ukraine	Novartis Investigative Site	Kharkiv
Ukraine	Novartis Investigative Site	Kiev
Ukraine	Novartis Investigative Site	Odessa
Ukraine	Novartis Investigative Site	Vinnitsya

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Czech Republic,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments	Safety outcomes will be described in Adverse events section as there was not an efficacy primary outcome	97 weeks	Yes
Secondary	Distribution of Patients With Relapses to End of Study (EOS) (All Subjects)	Description: number of relapses based on neurological assessments and EDSS	week 97	No
Secondary	Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI	Measures of absolute number of gadolinium [Gd]-enhancing lesions on T1-weighted scans	weeks 13,25,37,53,73 and 97	No
Secondary	Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI	Measures of absolute number of gadolinium [Gd]-enhancing lesions on T2-weighted lesions	weeks 13,25,37,53,73 and 97	No
Secondary	Change in Brain Volume at End of Study.	Change in volume from start to end of study	week 97	No
Secondary	Measure of Disability: Expanded Disability Status Scale (EDSS).	The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions.	Baseline to week 97	No