Clinical Trial: Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Subcutaneous
Brief 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.
Detailed Summary:
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.
Sponsor: Bayer
Current 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 [ Time Frame: At End of Study Visit (week 234) ]
Original Primary Outcome: The primary endpoint of this study is the safety and tolerability as defined by the incidence of patients experiencing flu-like syndrome, fever, myalgia, injection site reactions, asthenia, headache, and liver and bone marrow function abnormalities.
Current 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 [ Time Frame: At End of Study Visit (week 234) ]
Original Secondary Outcome:
Information By: Bayer
Dates:
Date Received: October 10, 2005
Date Started: June 2003
Date Completion:
Last Updated: April 25, 2014
Last Verified: April 2014