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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01185821
First Posted: August 20, 2010
Last Update Posted: November 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
August 19, 2010
August 20, 2010
November 13, 2017
August 2010
October 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 ]
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 ]
  • Long-term efficacy on paraclinical ground (neuroradiological measures of neurodegeneration) [ Time Frame: up to 15 months ]
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: Quadruple (Participant, Care Provider, 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
Kappos L, Li DK, Stüve O, Hartung HP, Freedman MS, Hemmer B, Rieckmann P, Montalban X, Ziemssen T, Hunter B, Arnould S, Wallström E, Selmaj K. Safety and Efficacy of Siponimod (BAF312) in Patients With Relapsing-Remitting Multiple Sclerosis: Dose-Blinded, Randomized Extension of the Phase 2 BOLD Study. JAMA Neurol. 2016 Sep 1;73(9):1089-98. doi: 10.1001/jamaneurol.2016.1451.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
185
October 2016
October 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

Sexes Eligible for Study: All
18 Years to 56 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Finland,   Germany,   Hungary,   Italy,   Norway,   Poland,   Russian Federation,   Spain,   Switzerland,   Turkey,   United States
 
 
NCT01185821
CBAF312A2201E1
2009-014392-51 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2017

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