Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri
|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.|
|ClinicalTrials.gov Identifier: NCT02137109|
Recruitment Status : Completed
First Posted : May 13, 2014
Last Update Posted : October 20, 2015
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis||Drug: natalizumab|
|Study Type :||Observational|
|Actual Enrollment :||400 participants|
|Official Title:||Meta-Analysis of the Safety and Efficacy of Natalizumab in Pediatric Patients With Multiple Sclerosis|
|Study Start Date :||March 2014|
|Primary Completion Date :||October 2015|
|Study Completion Date :||October 2015|
U.S. FDA Resources
Natalizumab will not be provided as a part of this study. Participants will receive natalizumab per the local label specifications.
Administered as specified in the treatment arm.
- Incidence of all serious adverse events (SAEs) [ Time Frame: Up to 19 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02137109
|Study Director:||Medical Director||Biogen|