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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
ClinicalTrials.gov Identifier:
NCT01185821
First received: August 19, 2010
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  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:

U.S. FDA Resources

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

  Show 80 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01185821     History of Changes
Other Study ID Numbers: CBAF312A2201E1, 2009-014392-51
Study First Received: August 19, 2010
Last Updated: January 18, 2013
Health Authority: 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
United States: Food and Drug Administration
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 June 18, 2013