Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis
NCT ID: NCT00235989
Last Updated: 2014-05-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2003-06-30
2008-01-31
Brief Summary
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Detailed Description
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Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ET: IFNB-1b 250 mcg => 250 mcg
Extension Treatment 250 mcg continued
Interferon beta 1b (Betaseron, BAY86-5046)
250 mcg administered s.c.(subcutaneous) every other day
ET: IFNB-1b 500 mcg => 250 mcg
Extension Treatment 500 mcg reduced to 250 mcg
Interferon beta 1b (Betaseron, BAY86-5046)
250 mcg administered s.c. every other day (for patients having received 500 mcg before)
ET: IFNB-1b 500 mcg => 500 mcg
Extension Treatment 500 mcg continued
Interferon beta 1b (Betaseron, BAY86-5046)
500 mcg administered s.c. every other day
ET: IFNB-1b 250 mcg => 500 mcg
Extension Treatment 250 mcg increased to 500 mcg
Interferon beta 1b (Betaseron, BAY86-5046)
500 mcg administered s.c. every other day (for patients having received 250 mcg before)
Interventions
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Interferon beta 1b (Betaseron, BAY86-5046)
250 mcg administered s.c.(subcutaneous) every other day
Interferon beta 1b (Betaseron, BAY86-5046)
250 mcg administered s.c. every other day (for patients having received 500 mcg before)
Interferon beta 1b (Betaseron, BAY86-5046)
500 mcg administered s.c. every other day
Interferon beta 1b (Betaseron, BAY86-5046)
500 mcg administered s.c. every other day (for patients having received 250 mcg before)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Completion of Protocol 307000A
* Negative serum pregnancy test results
* Agreement to adequate contraception, for female patients
Exclusion Criteria
* History of alcohol or drug abuse
* Inability to administer subcutaneous injections either by self or by caregiver
* Medical, psychiatric or other conditions that compromise the patient's ability to give informed consent, to understand the patient information, to comply with the study protocol, or to complete the study
* Any significant change in the patient's medical condition after enrollment in Study 307000A which would have lead to his/her exclusion from participation that study
18 Years
55 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Los Angeles, California, United States
San Francisco, California, United States
Washington D.C., District of Columbia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
Ann Arbor, Michigan, United States
Ann Arbor, Michigan, United States
Reno, Nevada, United States
Stony Brook, New York, United States
Durham, North Carolina, United States
High Point, North Carolina, United States
Winston-Salem, North Carolina, United States
Columbus, Ohio, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Countries
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Other Identifiers
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307320
Identifier Type: OTHER
Identifier Source: secondary_id
Beyond
Identifier Type: OTHER
Identifier Source: secondary_id
91272
Identifier Type: -
Identifier Source: org_study_id
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