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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Interferon beta-1b (Betaseron, BAY86-5046)

• Study Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

Study 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1	Drug: Interferon beta-1b (Betaseron, BAY86-5046); Patients under daily life treatment receiving Betaferon according to local product information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability of Betaferon in this patient population	Up 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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
Fatigue assessed by Fatigue Severity Scale (FSS)		Up to 24 months
MRI measurements (if available)	e.g. number of new T2 lesions, number of new contrast enhancing lesions	Up to 24 months
MRI measurements and potential correlation with neuropsychological impairment		Up to 24 months
Laboratory outcomes	Laboratory examinations: hemoglobin, mean corpuscular volume, platelets, leukocytes, ALAT/GPT, ASAT/GOT, Alkaline phosphatase, and Gamma-GT	Up to 24 months

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2009
• Primary Completion (Actual): April 12, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: August 21, 2009
• First Submitted That Met QC Criteria: August 21, 2009
• First Posted (Estimate): August 24, 2009

Study Record Updates

• Last Update Posted (Actual): July 12, 2017
• Last Update Submitted That Met QC Criteria: July 10, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; MS; Non-interventional
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferons; Interferon-beta; Interferon beta-1b
• Other Study ID Numbers: 14438; BF0802 (Other Identifier: NIS Trial Alias)