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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01185821
First received: August 19, 2010
Last updated: August 21, 2016
Last verified: August 2016

August 19, 2010
August 21, 2016
August 2010
September 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01185821 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally in Patients With Relapsing-remitting Multiple Sclerosis
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
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Relapsing Remitting Multiple Sclerosis
  • Autoimmune Diseases
  • Immune System Diseases
  • Nervous System Diseases
  • Autoimmune Diseases of the Nervous System
Drug: BAF312
  • Experimental: BAF312, 10 mg
    Intervention: Drug: BAF312
  • Experimental: BAF312, 2 mg
    Intervention: Drug: BAF312
  • Experimental: BAF312, 0.5 mg
    Intervention: Drug: BAF312
  • Experimental: BAF312, dose between 0.1- 8 mg blinded
    Intervention: Drug: BAF312
  • Experimental: BAF312, dose between 0.1- 8 mg blinded.
    Intervention: Drug: BAF312
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
September 2016
September 2016   (final data collection date for primary outcome measure)

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

Both
18 Years to 56 Years   (Adult)
No
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals +41613241111
United States,   Canada,   Finland,   Germany,   Hungary,   Italy,   Norway,   Poland,   Russian Federation,   Spain,   Switzerland,   Turkey
 
NCT01185821
CBAF312A2201E1, 2009-014392-51
Not Provided
Not Provided
Not Provided
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP