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

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ClinicalTrials.gov Identifier: NCT01185821
Recruitment Status : Completed
First Posted : August 20, 2010
Results First Posted : December 12, 2017
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Relapsing Remitting Multiple Sclerosis
Intervention: Drug: BAF312

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All patients enrolled in the Extension study had completed the Core study. All patients underwent a 10 day titration at the start of the dose blinded phase of the study

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During the double blind phase of the extension study patients received the same dose from the Core study. Placebo patients from Core Period 1 were randomized to 0.5, 2 or 10mg, those from Period 2 were randomized to 0.25 or 1.25 mg. All patients received 2mg in Open Label phase (.5 and .25mg were titrated up to 2mg)

Reporting Groups
  Description
BAF312 10 mg/2 mg 10 mg dose in Double Blind Phase and 2 mg in Open Label Phase
BAF312 2 mg/2 mg 2 mg dose in Double Blind Phase and 2 mg in Open Label Phase
BAF312 1.25 mg/2 mg 1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
BAF312 .5 mg/2 mg .5 mg dose in Double Blind Phase and 2 mg in Open Label Phase
BAF312 .25 mg/2 mg .25 mg dose in Double Blind Phase and 2 mg in Open Label Phase

Participant Flow:   Overall Study
    BAF312 10 mg/2 mg   BAF312 2 mg/2 mg   BAF312 1.25 mg/2 mg   BAF312 .5 mg/2 mg   BAF312 .25 mg/2 mg
STARTED   33   29   43   29   50 
Patients With Washout   33   29   39   29   33 
Patients Without Washout   0   0   4   0   17 
Patients on Placebo in Core   8   7   9   8   2 
COMPLETED   26   20   33   23   26 
NOT COMPLETED   7   9   10   6   24 
Abnormal laboratory value(s)                1                2                1                0                0 
Protocol Violation                0                0                0                1                1 
Abnormal test procedure result                0                0                0                0                1 
Death                0                1                0                0                0 
Condition no longer required study drug                0                0                0                0                1 
Adverse Event                2                3                1                2                5 
Lack of Efficacy                0                0                3                0                9 
Withdrawal by Subject                3                2                2                1                3 
Lost to Follow-up                1                1                2                1                2 
Administrative problems                0                0                1                1                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Extension set consisted of all patients who received at least one dose of Extension study drug who do not have a major protocol deviation.

Reporting Groups
  Description
BAF312 10 mg/2 mg 10 mg dose in Double Blind Phase and 2 mg in Open Label Phase
BAF312 2 mg/2 mg 2 mg dose in Double Blind Phase and 2 mg in Open Label Phase
BAF312 1.25 mg/2 mg 1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
BAF312 .5 mg/2 mg .5 mg dose in Double Blind Phase and 2 mg in Open Label Phase
BAF312 .25 mg/2 mg .25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
Total Total of all reporting groups

Baseline Measures
   BAF312 10 mg/2 mg   BAF312 2 mg/2 mg   BAF312 1.25 mg/2 mg   BAF312 .5 mg/2 mg   BAF312 .25 mg/2 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 33   29   43   29   50   184 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.8  (9.09)   35.1  (9.16)   34.0  (7.57)   35.2  (9.10)   37.2  (8.42)   35.7  (8.59) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      21  63.6%      18  62.1%      32  74.4%      18  62.1%      41  82.0%      130  70.7% 
Male      12  36.4%      11  37.9%      11  25.6%      11  37.9%      9  18.0%      54  29.3% 
Expanded disability status scale (EDSS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.03  (0.960)   2.19  (1.278)   1.95  (1.096)   1.88  (1.374)   2.22  (1.258)   2.07  (1.190) 
[1] Disability progression was assessed based on the EDSS scores ranging from 0 (normal) to 10 (death due to MS)


  Outcome Measures

1.  Primary:   Total Number of Adverse Events During Evaluation of Long Term Safety and Tolerability of BAF312A in Extension Study.   [ Time Frame: Baseline up to approximately 5 years ]

2.  Primary:   Number of Participants With Cardiac Conduction Abnormalities During the Titration Phase of the Study (Without Washout)   [ Time Frame: Baseline Extension up to day 10 ]

3.  Primary:   Number of Participants With Cardiac Conduction-IVCD Abnormality During the Titration Phase of the Study (With Washout)   [ Time Frame: Baseline Extension up to day 10 ]

4.  Primary:   Number of Participants With Changes in Blood Pressure for Overall Extension Study. (Extension Analysis Set)   [ Time Frame: Baseline Extension up to approximately 5 years ]

5.  Primary:   Number of Participants With Viral Infections of Interest Greater or Equal to 5% in Any Dose Group (Extension Set)   [ Time Frame: Baseline Extension up to approximately 5 years ]

6.  Primary:   Number of Participants With Dermatologic Alterations - Basal Cell Carcinoma (Extension Set)   [ Time Frame: Baseline Extension up to approximately 5 years ]

7.  Secondary:   Number of Relapses in One Year - Annualized Relapse Rates for Overall Extension Study (ARR) (Extension Set)   [ Time Frame: Baseline extension up to approximately 5 years ]

8.  Secondary:   Percentage of Participants Free of Magnetic Resonance Imaging (MRI) Identified Disease Activity at Any Scan During Extension Study (Extension Set)   [ Time Frame: Baseline Extension up to approximately 5 years ]

9.  Secondary:   Percentage of Participants Free of Confirmed Disability Progression in Extension Study (Extension Set)   [ Time Frame: Baseline Extension up to approximately 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300
e-mail: Novartis.email@novartis.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01185821     History of Changes
Other Study ID Numbers: CBAF312A2201E1
2009-014392-51 ( EudraCT Number )
First Submitted: August 19, 2010
First Posted: August 20, 2010
Results First Submitted: October 10, 2017
Results First Posted: December 12, 2017
Last Update Posted: March 27, 2018