Multiple SclerosisNCT00963833
Study Evaluating Betaferons Safety and Tolerability In Pediatric Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Bayer at 6 sites in 6 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Interferon beta-1b (Betaseron, BAY86-5046)
- How many people
- 68 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 17 Dec 2009to 1 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Treatment naive children and adolescents aged 12 to 16 years at inclusion diagnosed with RRMS.
Who may be able to join
- 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.
Who cannot join
- Contraindications stated in the local Betaferon product information; warnings and precautions must be considered.
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon beta-1b (Betaseron, BAY86-5046)
- Keywords
- Multiple Sclerosis, MS, Non-interventional
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon beta-1b (Betaseron, BAY86-5046)Drug
Patients under daily life treatment receiving Betaferon according to local product information.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Interferon beta-1b (Betaseron, BAY86-5046) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of Betaferon in this patient population
Measured: Up 24 months
Secondary outcomes (9)
Proportion of patients being relapse free
Measured: Up to 24 months
Time to first relapse
Measured: Up to 24 months
Annualized relapse rate
Measured: Up to 24 months
Disability progression measured by the expanded disability status scale (EDSS)
Measured: 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.
Measured: Up to 24 months
Fatigue assessed by Fatigue Severity Scale (FSS)
Measured: Up to 24 months
MRI measurements (if available)
e.g. number of new T2 lesions, number of new contrast enhancing lesions
Measured: Up to 24 months
MRI measurements and potential correlation with neuropsychological impairment
Measured: Up to 24 months
Laboratory outcomes
Laboratory examinations: hemoglobin, mean corpuscular volume, platelets, leukocytes, ALAT/GPT, ASAT/GOT, Alkaline phosphatase, and Gamma-GT
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2009 (estimated)
- Study start17 Dec 2009
- Primary completion12 Apr 2016
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963833
- Sponsor's protocol ID
- 14438
- Other IDs
- BF0802
- Status last verified
- Jul 2017
- First submitted
- 21 Aug 2009
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating Betaferons® Safety and Tolerability In Pediatric Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00963833
- Acronym / sponsor ID
- 14438
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, MS, Non-interventional
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2009 (actual)
- Primary completion
- 12 Apr 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 24 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Interferon beta-1b (Betaseron, BAY86-5046) |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Treatment naive children and adolescents aged 12 to 16 years at inclusion diagnosed with RRMS.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Contraindications stated in the local Betaferon product information; warnings and precautions must be considered.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon beta-1b (Betaseron, BAY86-5046)Patients under daily life treatment receiving Betaferon according to local product information. | Drug | Group 1 |
Primary outcome
Safety and tolerability of Betaferon in this patient population
Time frame: Up 24 months
9 secondary outcomes
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
Fatigue assessed by Fatigue Severity Scale (FSS)
Time frame: Up to 24 months
MRI measurements (if available)
Time frame: Up to 24 months
MRI measurements and potential correlation with neuropsychological impairment
Time frame: Up to 24 months
Laboratory outcomes
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Bayer at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Austria, Belgium, Finland, Germany, Israel and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of Betaferon in this patient population (time frame: Up 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.