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NCT Number: NCT00963833

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

Primary outcomes

  1. Safety and tolerability of Betaferon in this patient population

    Time frame: Up 24 months

Secondary outcomes

  1. Proportion of patients being relapse free

    Time frame: Up to 24 months

  2. Time to first relapse

    Time frame: Up to 24 months

  3. Annualized relapse rate

    Time frame: Up to 24 months

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

    Time frame: Up to 24 months

  5. 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.

  6. Fatigue assessed by Fatigue Severity Scale (FSS)

    Time frame: Up to 24 months

  7. MRI measurements (if available)

    Time frame: Up to 24 months

    e.g. number of new T2 lesions, number of new contrast enhancing lesions

  8. MRI measurements and potential correlation with neuropsychological impairment

    Time frame: Up to 24 months

  9. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Aug 24, 2009
Registry last updated
Jul 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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