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

NCT00963833 | Completed

• 2 other identifiers: 14438BF0802
• Study Type: observational
• Target: 68
• Locations: 6 countries
• Sites: 6

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; MS; Non-interventional

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of Betaferon in this patient population

  Up 24 months

Secondary Outcomes (9)

• Proportion of patients being relapse free

  Up to 24 months

• Time to first relapse

  Up to 24 months

• Annualized relapse rate

  Up to 24 months

• Disability progression measured by the expanded disability status scale (EDSS)

  Up to 24 months

• Outcome on neurological function

  Up to 24 months

Study Arms (1)

Group 1

Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Interventions

Interferon beta-1b (Betaseron, BAY86-5046) DRUG

Patients under daily life treatment receiving Betaferon according to local product information.

Group 1

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Treatment naive children and adolescents aged 12 to 16 years at inclusion diagnosed with RRMS.

You may not qualify if:

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (6)

Unknown Facility

Many Locations, Austria

Location

Unknown Facility

Many Locations, Belgium

Location

Unknown Facility

Many Locations, Finland

Location

Unknown Facility

Many Locations, Germany

Location

Unknown Facility

Many Locations, Israel

Location

Unknown Facility

Many Locations, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2009
• First Posted: August 24, 2009
• Study Start: December 17, 2009
• Primary Completion: April 12, 2016
• Study Completion: September 1, 2016
• Last Updated: July 12, 2017

Record last verified: 2017-07

Locations

AU (1); GB (1); BE (1); FI (1); IL (1); DE (1)