Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally in Patients With Relapsing-remitting Multiple Sclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01185821
First received: August 19, 2010
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

This blinded extension study is designed to offer patients with relapsing-remitting MS having completed the core study CBAF312A2201 access to BAF312 until they can enter an open label study. It will provide data on long-term safety, tolerability and efficacy of BAF312 in this patient population.


Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis
Autoimmune Diseases
Immune System Diseases
Nervous System Diseases
Autoimmune Diseases of the Nervous System
Drug: BAF312
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Dose Blinded Extension Study to the CBAF312A2201 Study to Evaluate Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally Once Daily in Patients With Relapsing-remitting Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Long-term safety and tolerability (emphasis on cardiovascular events, viral infections, macular edema and dermatologic alterations) [ Time Frame: up to 15 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Long-term efficacy on clinical ground (relapse rate, disability progression) [ Time Frame: up to 15 months ] [ Designated as safety issue: No ]
  • Long-term efficacy on paraclinical ground (neuroradiological measures of neurodegeneration) [ Time Frame: up to 15 months ] [ Designated as safety issue: No ]

Enrollment: 186
Study Start Date: August 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BAF312, 10 mg Drug: BAF312
Experimental: BAF312, 2 mg Drug: BAF312
Experimental: BAF312, 0.5 mg Drug: BAF312
Experimental: BAF312, dose between 0.1- 8 mg blinded Drug: BAF312
Experimental: BAF312, dose between 0.1- 8 mg blinded. Drug: BAF312

  Eligibility

Ages Eligible for Study:   18 Years to 56 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients completed the core study BAF312A2201
  • Written informed consent provided before any assessment of the extension study
  • Female patients at risk of becoming pregnant must have a negative pregnancy test and use simultaneously two forms of effective contraception

Exclusion Criteria:

  • Newly diagnosed systemic disease other than MS (which may require immunosuppressive treatment)
  • Malignancies, diabetes, significant cardiovascular and pulmonary diseases and conditions
  • Active infections

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01185821

  Hide Study Locations
Locations
United States, Florida
Novartis Investigative Site
Miami, Florida, United States, 33136
Novartis Investigative Site
Pompano Beach, Florida, United States, 33060
Novartis Investigative Site
Tallahassee, Florida, United States, 32308
United States, Illinois
Novartis Investigative Site
Chicago, Illinois, United States, 60637
United States, Michigan
Novartis Investigative Site
Grand Rapids, Michigan, United States, 49525
United States, Ohio
Novartis Investigative Site
Akron, Ohio, United States, 44320
United States, South Carolina
Novartis Investigative Site
Greenville, South Carolina, United States, 29607
United States, Washington
Novartis Investigative Site
Seattle, Washington, United States, 98122
Canada, Ontario
Novartis Investigative Site
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Novartis Investigative Site
Gatineau, Quebec, Canada, J9J 0A5
Novartis Investigative Site
Greenfield Park, Quebec, Canada, J4V 2J2
Finland
Novartis Investigative Site
Helsinki, Finland, 00100
Novartis Investigative Site
Tampere, Finland, FIN-33520
Germany
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Ibbenbüren, Germany, 49477
Novartis Investigative Site
Muenster, Germany, 48149
Novartis Investigative Site
München, Germany, 81675
Hungary
Novartis Investigative Site
Budapest, Hungary, 1076
Novartis Investigative Site
Budapest, Hungary, 1145
Novartis Investigative Site
Debrecen, Hungary, 4032
Novartis Investigative Site
Veszprem, Hungary, H-8200
Italy
Novartis Investigative Site
Montichiari, BS, Italy, 25018
Novartis Investigative Site
Chieti, CH, Italy, 66100
Novartis Investigative Site
Roma, RM, Italy, 00133
Novartis Investigative Site
Roma, RM, Italy, 00152
Norway
Novartis Investigative Site
Bergen, Norway, 5021
Novartis Investigative Site
Oslo, Norway, 0424
Poland
Novartis Investigative Site
Lodz, Poland, 90-153
Novartis Investigative Site
Lublin, Poland, 20-954
Novartis Investigative Site
Warsaw, Poland, 02-957
Russian Federation
Novartis Investigative Site
Kazan, Russian Federation, 420103
Novartis Investigative Site
Moscow, Russian Federation, 125367
Novartis Investigative Site
Moscow, Russian Federation, 127018
Novartis Investigative Site
Sankt-Peterburg, Russian Federation, 197022
Novartis Investigative Site
St. Petersburg, Russian Federation, 198013
Spain
Novartis Investigative Site
Sevilla, Andalucia, Spain, 41009
Novartis Investigative Site
Barcelona, Cataluña, Spain, 08035
Novartis Investigative Site
Valencia, Comunidad Valenciana, Spain, 46026
Switzerland
Novartis Investigative Site
Basel, Switzerland, 4031
Novartis Investigative Site
Lugano, Switzerland, 6900
Novartis Investigative Site
Zuerich, Switzerland, 8091
Turkey
Novartis Investigative Site
Ankara, Turkey, 06100
Novartis Investigative Site
Haseki / Istanbul, Turkey, 34096
Novartis Investigative Site
Istanbul, Turkey, 34093
Novartis Investigative Site
Izmir, Turkey, 35340
Novartis Investigative Site
Kocaeli, Turkey, 41380
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: NCT01185821     History of Changes
Other Study ID Numbers: CBAF312A2201E1, 2009-014392-51
Study First Received: August 19, 2010
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
Turkey: Ministry of Health

Keywords provided by Novartis:
Multiple Sclerosis
Relapsing remitting Multiple Sclerosis
Demyelinating Autoimmune Diseases

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases
Multiple Sclerosis
Nervous System Diseases
Sclerosis
Autoimmune Diseases of the Nervous System
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014