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

Sponsor:	Novartis
Information provided by (Responsible Party):	Novartis
ClinicalTrials.gov Identifier:	NCT01185821

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:

MedlinePlus related topics: Autoimmune Diseases Multiple Sclerosis Neurologic Diseases

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:	July 2010
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 2012 (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

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:	November 22, 2011
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 and Social Development 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 May 24, 2012