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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00963833
First Posted: August 24, 2009
Last Update Posted: July 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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: Up 24 months ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 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) [ Time Frame: Up to 24 months ]
  • MRI measurements (if available) [ Time Frame: Up to 24 months ]
    e.g. number of new T2 lesions, number of new contrast enhancing lesions

  • MRI measurements and potential correlation with neuropsychological impairment [ Time Frame: Up to 24 months ]
  • Laboratory outcomes [ Time Frame: Up to 24 months ]
    Laboratory examinations: hemoglobin, mean corpuscular volume, platelets, leukocytes, ALAT/GPT, ASAT/GOT, Alkaline phosphatase, and Gamma-GT


Enrollment: 68
Actual Study Start Date: December 17, 2009
Study Completion Date: September 1, 2016
Primary Completion Date: April 12, 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00963833     History of Changes
Other Study ID Numbers: 14438
BF0802 ( Other Identifier: NIS Trial Alias )
First Submitted: August 21, 2009
First Posted: August 24, 2009
Last Update Posted: July 12, 2017
Last Verified: July 2017

Keywords provided by Bayer:
Multiple Sclerosis
MS
Non-interventional

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