Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis
Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis, Relapsing-Remitting
Intervention: Interferon beta 1b (Betaseron, BAY86-5046) (Drug); Interferon beta 1b (Betaseron, BAY86-5046) (Drug); Interferon beta 1b (Betaseron, BAY86-5046) (Drug); Interferon beta 1b (Betaseron, BAY86-5046) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
The purpose of this study is to determine if a higher dose of study drug is more effective
in preventing relapses in patients with Multiple Sclerosis.
Clinical Details
Official title: An Open-label Extension Study of the Double-blind, Randomized, Parallel Group, Multicenter Phase 2 Study 307000A to Further Evaluate the Safety and Tolerability of Betaseron® 500 mcg Subcutaneously Every Other Day and Betaseron® 250 mcg Subcutaneously Every Other Day in Patients With Relapsing-remitting Multiple Sclerosis (RRMS)
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities
Secondary outcome: Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b
Detailed description:
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer
HealthCare Pharmaceuticals, Inc.
Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Signed and dated statement of informed consent
- Completion of Protocol 307000A
- Negative serum pregnancy test results
- Agreement to adequate contraception, for female patients
Exclusion Criteria:
- Pregnancy or lactation
- 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
Locations and Contacts
Los Angeles, California 90095-1721, United States
San Francisco, California 94117, United States
Washington, District of Columbia 20037, United States
Atlanta, Georgia 30309-1465, United States
Chicago, Illinois 60637, United States
Kansas City, Kansas 66160, United States
Louisville, Kentucky 40202, United States
Ann Arbor, Michigan 48109, United States
Ann Arbor, Michigan 48109-0022, United States
Reno, Nevada 89509, United States
Stony Brook, New York 11794, United States
Durham, North Carolina 27710, United States
High Point, North Carolina 27262, United States
Winston-Salem, North Carolina 27157, United States
Columbus, Ohio 43221, United States
Nashville, Tennessee 37212, United States
Nashville, Tennessee 37232, United States
Additional Information
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Starting date: June 2003
Last updated: April 25, 2014
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