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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
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* Drug: 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)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ET: IFNB-1b 250 mcg => 250 mcg<br>Extension Treatment 250 mcg continued | Drug: Interferon beta 1b (Betaseron, BAY86-5046)<br>* 250 mcg administered s.c.(subcutaneous) every other day<br>* Other names: Betaferon;|
| Experimental: ET: IFNB-1b 500 mcg => 250 mcg<br>Extension Treatment 500 mcg reduced to 250 mcg | Drug: Interferon beta 1b (Betaseron, BAY86-5046)<br>* 250 mcg administered s.c. every other day (for patients having received 500 mcg before)<br>* Other names: Betaferon;|
| Experimental: ET: IFNB-1b 500 mcg => 500 mcg<br>Extension Treatment 500 mcg continued | Drug: Interferon beta 1b (Betaseron, BAY86-5046)<br>* 500 mcg administered s.c. every other day<br>* Other names: Betaferon;|
| Experimental: ET: IFNB-1b 250 mcg => 500 mcg<br>Extension Treatment 250 mcg increased to 500 mcg | Drug: Interferon beta 1b (Betaseron, BAY86-5046)<br>* 500 mcg administered s.c. every other day (for patients having received 250 mcg before)<br>* Other names: Betaferon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | At End of Study Visit (week 234) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b | 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). | At End of Study Visit (week 234) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapsing multiple sclerosis, interferon beta 1b, Betaferon, Betaseron