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: May 21, 2014
Last verified: May 2014

August 19, 2010
May 21, 2014
August 2010
December 2015   (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: 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.
 
Active, not recruiting
186
December 2015
December 2015   (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
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Finland,   Germany,   Hungary,   Italy,   Norway,   Poland,   Russian Federation,   Spain,   Switzerland,   Turkey
 
NCT01185821
CBAF312A2201E1, 2009-014392-51
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2014

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