Back to resultsExtension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis
Primary Purpose
Multiple Sclerosis, Relapsing-Remitting
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Interferon beta 1b (Betaseron, BAY86-5046)
Interferon beta 1b (Betaseron, BAY86-5046)
Interferon beta 1b (Betaseron, BAY86-5046)
Interferon beta 1b (Betaseron, BAY86-5046)
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring Relapsing multiple sclerosis, interferon beta 1b, Betaferon, Betaseron
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
ET: IFNB-1b 250 mcg => 250 mcg
ET: IFNB-1b 500 mcg => 250 mcg
ET: IFNB-1b 500 mcg => 500 mcg
ET: IFNB-1b 250 mcg => 500 mcg
Arm Description
Extension Treatment 250 mcg continued
Extension Treatment 500 mcg reduced to 250 mcg
Extension Treatment 500 mcg continued
Extension Treatment 250 mcg increased to 500 mcg
Outcomes
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
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
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00235989
Brief Title
Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
Relapsing multiple sclerosis, interferon beta 1b, Betaferon, Betaseron
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ET: IFNB-1b 250 mcg => 250 mcg
Arm Type
Active Comparator
Arm Description
Extension Treatment 250 mcg continued
Arm Title
ET: IFNB-1b 500 mcg => 250 mcg
Arm Type
Experimental
Arm Description
Extension Treatment 500 mcg reduced to 250 mcg
Arm Title
ET: IFNB-1b 500 mcg => 500 mcg
Arm Type
Experimental
Arm Description
Extension Treatment 500 mcg continued
Arm Title
ET: IFNB-1b 250 mcg => 500 mcg
Arm Type
Experimental
Arm Description
Extension Treatment 250 mcg increased to 500 mcg
Intervention Type
Drug
Intervention Name(s)
Interferon beta 1b (Betaseron, BAY86-5046)
Other Intervention Name(s)
Betaferon
Intervention Description
250 mcg administered s.c.(subcutaneous) every other day
Intervention Type
Drug
Intervention Name(s)
Interferon beta 1b (Betaseron, BAY86-5046)
Other Intervention Name(s)
Betaferon
Intervention Description
250 mcg administered s.c. every other day (for patients having received 500 mcg before)
Intervention Type
Drug
Intervention Name(s)
Interferon beta 1b (Betaseron, BAY86-5046)
Other Intervention Name(s)
Betaferon
Intervention Description
500 mcg administered s.c. every other day
Intervention Type
Drug
Intervention Name(s)
Interferon beta 1b (Betaseron, BAY86-5046)
Other Intervention Name(s)
Betaferon
Intervention Description
500 mcg administered s.c. every other day (for patients having received 250 mcg before)
Primary Outcome Measure Information:
Title
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
Description
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 Outcome Measure Information:
Title
Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1721
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309-1465
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0022
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
City
Reno
State/Province
Nevada
ZIP/Postal Code
89509
Country
United States
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis
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