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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

Page last updated: August 20, 2015

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