Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis

Phase 2

Completed

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Drug: Interferon beta 1b (Betaseron, BAY86-5046)

• Registration Number: NCT00235989
• Lead Sponsor: Bayer

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 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.

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2005-10-10
• Study First Submitted QC: 2005-10-10
• Study First Posted: 2005-10-12
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2009-01-30
• Results First Submitted QC: 2009-05-13
• Results First Posted: 2009-07-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-25
• Last Update Posted: 2014-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ET: IFNB-1b 250 mcg => 250 mcg	Interferon beta 1b (Betaseron, BAY86-5046)	Extension Treatment 250 mcg continued
ET: IFNB-1b 500 mcg => 250 mcg	Interferon beta 1b (Betaseron, BAY86-5046)	Extension Treatment 500 mcg reduced to 250 mcg
ET: IFNB-1b 500 mcg => 500 mcg	Interferon beta 1b (Betaseron, BAY86-5046)	Extension Treatment 500 mcg continued
ET: IFNB-1b 250 mcg => 500 mcg	Interferon beta 1b (Betaseron, BAY86-5046)	Extension Treatment 250 mcg increased to 500 mcg

Primary Outcome Measures

Name	Time	Method
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	At End of Study Visit (week 234)	Outcome measures are given as the number of patients with common toxicity by the Common Toxicity Criteria (CTC). Toxicity grading is: Grade 1: no study drug action recommended, Grade 2: Dose reduction or interruption of study treatment should be considered (grade 2 Lymphocyte toxicity required no study drug action), Grade 3: Dose reduction or interruption should be considered; interruption is recommended, and Grade 4: Interruption of study drug is recommended (Grade 4 laboratory toxicity was reported as a serious adverse event). Liver and bone marrow abnormalities are measured by lab tests.

Secondary Outcome Measures

Name	Time	Method
Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b	At End of Study Visit (week 234)	Serum samples for analysis of NAbs to interferon (IFN) beta-1b were collected in Study 307000A. In the extension study, NAbs were also monitored for information on persistence or resolution. Serum samples of about 6 mL for NAbs were drawn at Weeks 10, 24, 52, 78, 104 130, 156, 182, 208, 234, 260, 286 or the EOS visit. (NU/ml=neutralizing units/ml).