An observational study in Multiple Sclerosis, sponsored by Bayer. Completed at 6 sites in 6 countries. Open to participants aged 12 Years to 16 Years. Per ClinicalTrials.gov, last updated 2017-07-12.
Sponsored by Bayer · Observational
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.
3,524 studies on the registry are indexed under Multiple Sclerosis; 668 are open to participants now.
This study's enrollment of 68 is below the median of 100 across 1,034 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Bayer is the lead sponsor of 1,674 studies on the registry; 54 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 130 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Treatment naive children and adolescents aged 12 to 16 years at inclusion diagnosed with RRMS.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
Time frame: Up to 24 months
Fatigue assessed by Fatigue Severity Scale (FSS)
Time frame: Up to 24 months
MRI measurements (if available)
e.g. number of new T2 lesions, number of new contrast enhancing lesions
Time frame: Up to 24 months
MRI measurements and potential correlation with neuropsychological impairment
Time frame: Up to 24 months
Laboratory outcomes
Laboratory examinations: hemoglobin, mean corpuscular volume, platelets, leukocytes, ALAT/GPT, ASAT/GOT, Alkaline phosphatase, and Gamma-GT
Time frame: Up to 24 months
Ran from Dec 2009 to primary completion in Apr 2016, 75 months.
Of 99 industry-sponsored observational studies under Multiple Sclerosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 75. This study's 75 months is above that.
Counting every sponsor, half of 440 studies reached it within 41 months; a quarter within 15 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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