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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00235989
First received: October 10, 2005
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Drug: Interferon beta 1b (Betaseron, BAY86-5046)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    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:
  • 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) ] [ Designated as safety issue: No ]
    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).


Enrollment: 63
Study Start Date: June 2003
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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. every other day (for patients having received 500 mcg before)
Other Name: Betaferon
Experimental: ET: IFNB-1b 500 mcg => 500 mcg
Extension Treatment 500 mcg continued
Drug: Interferon beta 1b (Betaseron, BAY86-5046)
500 mcg administered s.c. every other day
Other Name: Betaferon
Experimental: ET: IFNB-1b 250 mcg => 500 mcg
Extension Treatment 250 mcg increased to 500 mcg
Drug: Interferon beta 1b (Betaseron, BAY86-5046)
500 mcg administered s.c. every other day (for patients having received 250 mcg before)
Other Name: Betaferon

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235989

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00235989     History of Changes
Other Study ID Numbers: 91272, 307320, Beyond
Study First Received: October 10, 2005
Results First Received: January 30, 2009
Last Updated: April 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Relapsing multiple sclerosis
interferon beta 1b
Betaferon
Betaseron

Additional relevant MeSH terms:
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
Interferons
Interferon beta-1b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on July 20, 2014