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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963833
• Other study ID #: 14438
• Secondary ID: BF0802
• Status: Completed
• Phase: N/A
• First received: August 21, 2009
• Last updated: July 10, 2017
• Start date: December 17, 2009
• Est. completion date: September 1, 2016

Study information

• Verified date: July 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: September 1, 2016
• Est. primary completion date: April 12, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Interferon beta-1b (Betaseron, BAY86-5046)
Patients under daily life treatment receiving Betaferon according to local product information.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Belgium,  Finland,  Germany,  Israel,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of Betaferon in this patient population		Up 24 months
Secondary	Proportion of patients being relapse free		Up to 24 months
Secondary	Time to first relapse		Up to 24 months
Secondary	Annualized relapse rate		Up to 24 months
Secondary	Disability progression measured by the expanded disability status scale (EDSS)		Up to 24 months
Secondary	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.	Up to 24 months
Secondary	Fatigue assessed by Fatigue Severity Scale (FSS)		Up to 24 months
Secondary	MRI measurements (if available)	e.g. number of new T2 lesions, number of new contrast enhancing lesions	Up to 24 months
Secondary	MRI measurements and potential correlation with neuropsychological impairment		Up to 24 months
Secondary	Laboratory outcomes	Laboratory examinations: hemoglobin, mean corpuscular volume, platelets, leukocytes, ALAT/GPT, ASAT/GOT, Alkaline phosphatase, and Gamma-GT	Up to 24 months

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