Study Evaluating Betaferons® Safety and Tolerability In Pediatric Patients With Multiple Sclerosis
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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 |
- Safety and tolerability of Betaferon in this patient population [ Time Frame: after 6, 12, 18, and 24 months ] [ Designated as safety issue: Yes ]
- Annualised relapse rate [ Time Frame: after 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
- Disability progression [ Time Frame: after 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
- Outcome on neuropsychological function [ Time Frame: after 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
- MRI measurements (if available) [ Time Frame: after 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
- MRI measurements and potential correlation with neuropsychological impairment [ Time Frame: after 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 |
Treatment naive children and adolescents aged 12 to 16 years at inclusion diagnosed with RRMS.
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| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
| Austria | |
| Recruiting | |
| Many Locations, Austria | |
| Belgium | |
| Recruiting | |
| Many Locations, Belgium | |
| Finland | |
| Recruiting | |
| Many Locations, Finland | |
| Germany | |
| Recruiting | |
| Many Locations, Germany | |
| Italy | |
| Terminated | |
| Many Locations, Italy | |
| Portugal | |
| Not yet recruiting | |
| Many Locations, Portugal | |
| United Kingdom | |
| Recruiting | |
| Many Locations, United Kingdom | |
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Affairs Therapeutic Area Head, Bayer HealthCare AG |
| ClinicalTrials.gov Identifier: | NCT00963833 History of Changes |
| Other Study ID Numbers: | 14438, BF0802 |
| Study First Received: | August 21, 2009 |
| Last Updated: | May 9, 2013 |
| 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: Directorate general for the protection of Public health: Medicines Portugal: Ethics Committee for Clinical Research |
Keywords provided by Bayer:
|
Multiple Sclerosis MS Non-interventional |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Interferon-beta |
Interferons Interferon beta-1b Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 19, 2013