Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon (INFLUENCE)
This study is currently recruiting participants.
Verified April 2013 by Bayer
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01706055
First received: September 7, 2012
Last updated: April 30, 2013
Last verified: April 2013
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 7, 2012 | ||||
| Last Updated Date | April 30, 2013 | ||||
| Start Date ICMJE | September 2012 | ||||
| Estimated Primary Completion Date | September 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Mean severity score of Flu-Like Symptoms (FLS) recorded within the first 6 months following treatment initiation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01706055 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon (INFLUENCE) | ||||
| Official Title ICMJE | Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon® | ||||
| Brief Summary | This will be prospective, multicentre, observational study. Patients who will initiate treatment with IFNβ-1b (Betaferon) will be followed up to 6 months. Baseline visit (visit 0) i.e. treatment initiation plus four follow-up visits (visits 1-4). For each patient demographics, medical history data, safety parameters, presence of flu-like symptoms and measures to prevent or treat these symptoms will be collected. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Adult MS patients starting Betaferon therapy |
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| Condition ICMJE | Multiple Sclerosis | ||||
| Intervention ICMJE | Biological: Interferon beta-1b (Betaseron, BAY86-5046)
Subcutaneous injections of Betaferon 250 mcg every other day according to Product Characteristic. |
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| Study Group/Cohort (s) | Group 1
Intervention: Biological: Interferon beta-1b (Betaseron, 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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 600 | ||||
| Estimated Completion Date | December 2015 | ||||
| Estimated Primary Completion Date | September 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Poland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01706055 | ||||
| Other Study ID Numbers ICMJE | 16400, BF1213PL | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Medical Director, Bayer Sp. z o.o. | ||||
| Study Sponsor ICMJE | Bayer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Bayer | ||||
| Verification Date | April 2013 | ||||
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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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