BENEFIT Extension Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00544037 |
Recruitment Status :
Completed
First Posted : October 16, 2007
Last Update Posted : March 5, 2012
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Condition or disease | Intervention/treatment |
---|---|
Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) |
Study Type : | Observational |
Actual Enrollment : | 283 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Extension Study of the BENEFIT (304747) and BENEFIT Follow-up (305207) Studies to Further Evaluate the Progress of Patients With First Demyelinating Event Suggestive of Multiple Sclerosis |
Study Start Date : | September 2007 |
Actual Primary Completion Date : | January 2011 |
Actual Study Completion Date : | January 2011 |

Group/Cohort | Intervention/treatment |
---|---|
Group 1 |
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Standard Therapy for Multiple Sclerosis |
- To obtain further clinical data of patients with a first demyelinating event suggestive of Multiple Sclerosis enrolled in the BENEFIT Study [ Time Frame: End of Study ]
Biospecimen Retention: None Retained

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Ages Eligible for Study: | 23 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- All patients randomized and treated at least once in study 304747
Exclusion Criteria:
- Medical, psychiatric or other conditions that compromise the patient's ability to understand the purpose of the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544037
Austria | |
Many Locations, Austria | |
Belgium | |
Many Locations, Belgium | |
Canada | |
Many Locations, Canada | |
Czech Republic | |
Many Locations, Czech Republic | |
Denmark | |
Many Locations, Denmark | |
Finland | |
Many Locations, Finland | |
France | |
Many Locations, France | |
Germany | |
Many Locations, Germany | |
Hungary | |
Many Locations, Hungary | |
Israel | |
Many Locations, Israel | |
Italy | |
Many Locations, Italy | |
Netherlands | |
Many Locations, Netherlands | |
Norway | |
Many Locations, Norway | |
Poland | |
Many Locations, Poland | |
Slovenia | |
Many Locations, Slovenia | |
Spain | |
Many Locations, Spain | |
Sweden | |
Many Locations, Sweden | |
Switzerland | |
Many Locations, Switzerland |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Global Medical Affairs Therapeutic Area Head, Byer Healthcare AG |
ClinicalTrials.gov Identifier: | NCT00544037 |
Other Study ID Numbers: |
91713 311129 ( Other Identifier: Company internal ) |
First Posted: | October 16, 2007 Key Record Dates |
Last Update Posted: | March 5, 2012 |
Last Verified: | March 2012 |
Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
Interferons Interferon-beta Interferon beta-1b Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic |