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

April 25, 2014 updated by: Bayer

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-1721
      • San Francisco, California, United States, 94117
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
    • Georgia
      • Atlanta, Georgia, United States, 30309-1465
    • Illinois
      • Chicago, Illinois, United States, 60637
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
      • Ann Arbor, Michigan, United States, 48109-0022
    • Nevada
      • Reno, Nevada, United States, 89509
    • New York
      • Stony Brook, New York, United States, 11794
    • North Carolina
      • Durham, North Carolina, United States, 27710
      • High Point, North Carolina, United States, 27262
      • Winston-Salem, North Carolina, United States, 27157
    • Ohio
      • Columbus, Ohio, United States, 43221
    • Tennessee
      • Nashville, Tennessee, United States, 37212
      • Nashville, Tennessee, United States, 37232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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
Time Frame: 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.
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
Time Frame: 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).
At End of Study Visit (week 234)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

October 10, 2005

First Submitted That Met QC Criteria

October 10, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Estimate)

May 8, 2014

Last Update Submitted That Met QC Criteria

April 25, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91272
  • BEYOND (Company internal)
  • 307320 (Other Identifier: Company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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