Study Evaluating Betaferons Safety and Tolerability In Pediatric Patients With Multiple Sclerosis

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Interferon beta-1b (Betaseron, BAY86-5046)

• Registration Number: NCT00963833
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-08-21
• Study First Submitted QC: 2009-08-21
• Study First Posted: 2009-08-24
• Study Start: 2009-12-17
• Primary Completion: 2016-04-12
• Study Completion: 2016-09-01
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-10
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Treatment naive children and adolescents of 12 to 16 years of age at inclusion with a diagnosis of RRMS according to revised McDonald or Poser criteria and decision taken by the investigator to treat with Betaferon. The local Betaferon product information must be considered.

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Exclusion Criteria

• Contraindications stated in the local Betaferon product information; warnings and precautions must be considered.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Interferon beta-1b (Betaseron, BAY86-5046)	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of Betaferon in this patient population	Up 24 months

Secondary Outcome Measures

Name	Time	Method
MRI measurements and potential correlation with neuropsychological impairment	Up to 24 months
Time to first relapse	Up to 24 months
Disability progression measured by the expanded disability status scale (EDSS)	Up to 24 months
Proportion of patients being relapse free	Up to 24 months
Annualized relapse rate	Up to 24 months
Outcome on neurological function	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)	Up to 24 months
MRI measurements (if available)	Up to 24 months	e.g. number of new T2 lesions, number of new contrast enhancing lesions
Laboratory outcomes	Up to 24 months	Laboratory examinations: hemoglobin, mean corpuscular volume, platelets, leukocytes, ALAT/GPT, ASAT/GOT, Alkaline phosphatase, and Gamma-GT