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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00963833
First received: August 21, 2009
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study Evaluating Betaferons® Safety and Tolerability In Pediatric Patients With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Safety and tolerability of Betaferon in this patient population [ Time Frame: At 6, 12, 18, and 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Annualised relapse rate [ Time Frame: At 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
  • Disability progression [ Time Frame: At 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
  • Outcome on neuropsychological function [ Time Frame: At baseline and 24 months ] [ Designated as safety issue: No ]
  • MRI measurements (if available) [ Time Frame: At 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
  • MRI measurements and potential correlation with neuropsychological impairment [ Time Frame: At 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2009
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Patients under daily life treatment receiving Betaferon according to local product information.

  Eligibility

Ages Eligible for Study:   12 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963833

Locations
Austria
Many Locations, Austria
Belgium
Many Locations, Belgium
Finland
Many Locations, Finland
Germany
Many Locations, Germany
Israel
Many Locations, Israel
United Kingdom
Many Locations, United Kingdom
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00963833     History of Changes
Other Study ID Numbers: 14438, BF0802
Study First Received: August 21, 2009
Last Updated: October 13, 2014
Health Authority: Austria: Department of Health
Finland: Ethics Committee
Finland: Ministry of Social Affairs and Health
Finland: Finnish Medicines Agency
United Kingdom: Research Ethics Committee
Italy: Ethics Committee
Germany: Federal Institute for Drugs and Medical Devices
Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Bayer:
Multiple Sclerosis
MS
Non-interventional

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Interferon beta-1b
Interferon-beta
Adjuvants, Immunologic
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014