Telephone Interview of Patients That Participated in the the Pivotal Betaferon MS Trial.
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01031459
First received: December 8, 2009
Last updated: January 3, 2012
Last verified: January 2012
| Tracking Information | |||||
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| First Received Date ICMJE | December 8, 2009 | ||||
| Last Updated Date | January 3, 2012 | ||||
| Start Date ICMJE | January 2010 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Descriptive exploration of mortality, EDSS, cognition, resource use, SPMS status and employment history by length of exposure to Betaseron and stratified by the original clinical trial group assignment (1.6 MIU, 8 MIU, placebo) [ Time Frame: 20 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01031459 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Telephone Interview of Patients That Participated in the the Pivotal Betaferon MS Trial. | ||||
| Official Title ICMJE | An Observational 20-year, Cross-sectional, Long-term Follow up of the Patient Cohort Enrolled in the Pivotal Study of Betaseron® (Interferon Beta-1b) in Relapsing-remitting Multiple Sclerosis | ||||
| Brief Summary | The purpose of this study is to investigate the clinical status of patients who participated in the original pivotal Betaseron study at 20 years after randomized treatment initiationStudy end-points include:
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: None Retained Description: n.a |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with MS that participated in the 16Y-LTF and Pivitol studies |
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| Condition ICMJE | Multiple Sclerosis | ||||
| Intervention ICMJE | Drug: Betaseron (Interferon beta-1b, BAY86-5046)
Telephone survey of all patients. |
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| Study Group/Cohort (s) | Group 1
Intervention: Drug: Betaseron (Interferon beta-1b, BAY86-5046) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 176 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01031459 | ||||
| Other Study ID Numbers ICMJE | 14261, 20Y-LTF | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Global Medical Affairs Therapeutic Area Head, Bayer Healthcare Phamaceuticals Inc. | ||||
| Study Sponsor ICMJE | Bayer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Bayer | ||||
| Verification Date | January 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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