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

Bayer63 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Interferon beta 1b (Betaseron, BAY86-5046)DRUG

250 mcg administered s.c.(subcutaneous) every other day

Interferon beta 1b (Betaseron, BAY86-5046)DRUG

250 mcg administered s.c. every other day (for patients having received 500 mcg before)

Interferon beta 1b (Betaseron, BAY86-5046)DRUG

500 mcg administered s.c. every other day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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 (17)

Unnamed facility

Los Angeles, California, United States

Unnamed facility

San Francisco, California, United States

Unnamed facility

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

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.

Time frame: At End of Study Visit (week 234)

Secondary Outcomes

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).

Time frame: At End of Study Visit (week 234)

Data from ClinicalTrials.gov

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