Study Evaluating Betaferons Safety and Tolerability In Pediatric Patients With Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT00963833|
Recruitment Status : Completed
First Posted : August 24, 2009
Last Update Posted : July 12, 2017
Multiple Sclerosis (MS) is mainly known as a disease of young to middle adulthood but approximately 5% of all MS cases worldwide involve children that are younger than 16 years.
The aim of care of children with Multiple Sclerosis is to prevent or at least to delay any neurological and cognitive impairment as well as progression of the disease as far as possible. Therefore, it is very crucial to diagnose the disease at an early stage as immunomodulatory treatments are available that can delay the progression of Multiple SclerosisTreatment with the immunomodulatory agent Betaferon® in children diagnosed with RRMS and being 12 years or older has been approved by the health authorities. The aim of this observational study is to obtain further data on the safety, tolerability, and effectiveness of Betaferon® under daily living conditions.
As this is a non-interventional observational study, routine clinical practice is observed. The application of diagnostic measures and medications as well as physician visits follow the normal routine and is decided upon by the treating physician under recognition of the package insert.
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis||Drug: Interferon beta-1b (Betaseron, BAY86-5046)|
|Study Type :||Observational|
|Actual Enrollment :||68 participants|
|Official Title:||Study Evaluating Betaferons® Safety and Tolerability In Pediatric Patients With Multiple Sclerosis|
|Actual Study Start Date :||December 17, 2009|
|Actual Primary Completion Date :||April 12, 2016|
|Actual Study Completion Date :||September 1, 2016|
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Patients under daily life treatment receiving Betaferon according to local product information.
- Safety and tolerability of Betaferon in this patient population [ Time Frame: Up 24 months ]
- Proportion of patients being relapse free [ Time Frame: Up to 24 months ]
- Time to first relapse [ Time Frame: Up to 24 months ]
- Annualized relapse rate [ Time Frame: Up to 24 months ]
- Disability progression measured by the expanded disability status scale (EDSS) [ Time Frame: Up to 24 months ]
- Outcome on neurological function [ Time Frame: Up to 24 months ]e.g. IQ assessment using Standard Progressive Matrices (SPM) and Wechsler intelligence scale for children-fourth edition (WISCIV®), assessment of visual and motor integration using Beery VMI , and assessment of attention and concentration using d2 test.
- Fatigue assessed by Fatigue Severity Scale (FSS) [ Time Frame: Up to 24 months ]
- MRI measurements (if available) [ Time Frame: Up to 24 months ]e.g. number of new T2 lesions, number of new contrast enhancing lesions
- MRI measurements and potential correlation with neuropsychological impairment [ Time Frame: Up to 24 months ]
- Laboratory outcomes [ Time Frame: Up to 24 months ]Laboratory examinations: hemoglobin, mean corpuscular volume, platelets, leukocytes, ALAT/GPT, ASAT/GOT, Alkaline phosphatase, and Gamma-GT
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): NCT00963833
|Many Locations, Austria|
|Many Locations, Belgium|
|Many Locations, Finland|
|Many Locations, Germany|
|Many Locations, Israel|
|Many Locations, United Kingdom|
|Study Director:||Bayer Study Director||Bayer|