Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis
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)
3 other identifiers
interventional
63
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2003
Typical duration for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 10, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedResults Posted
Study results publicly available
July 3, 2009
CompletedMay 8, 2014
April 1, 2014
4.6 years
October 10, 2005
January 30, 2009
April 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b
At End of Study Visit (week 234)
Study Arms (4)
ET: IFNB-1b 250 mcg => 250 mcg
ACTIVE COMPARATORExtension Treatment 250 mcg continued
ET: IFNB-1b 500 mcg => 250 mcg
EXPERIMENTALExtension Treatment 500 mcg reduced to 250 mcg
ET: IFNB-1b 500 mcg => 500 mcg
EXPERIMENTALExtension Treatment 500 mcg continued
ET: IFNB-1b 250 mcg => 500 mcg
EXPERIMENTALExtension Treatment 250 mcg increased to 500 mcg
Interventions
250 mcg administered s.c.(subcutaneous) every other day
Eligibility Criteria
You may qualify if:
- Signed and dated statement of informed consent
- Completion of Protocol 307000A
- Negative serum pregnancy test results
- Agreement to adequate contraception, for female patients
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (17)
Unknown Facility
Los Angeles, California, 90095-1721, United States
Unknown Facility
San Francisco, California, 94117, United States
Unknown Facility
Washington D.C., District of Columbia, 20037, United States
Unknown Facility
Atlanta, Georgia, 30309-1465, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Kansas City, Kansas, 66160, United States
Unknown Facility
Louisville, Kentucky, 40202, United States
Unknown Facility
Ann Arbor, Michigan, 48109-0022, United States
Unknown Facility
Ann Arbor, Michigan, 48109, United States
Unknown Facility
Reno, Nevada, 89509, United States
Unknown Facility
Stony Brook, New York, 11794, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
High Point, North Carolina, 27262, United States
Unknown Facility
Winston-Salem, North Carolina, 27157, United States
Unknown Facility
Columbus, Ohio, 43221, United States
Unknown Facility
Nashville, Tennessee, 37212, United States
Unknown Facility
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The 40 patients in the NAb frequency summaries are the total number of patients with NAb titers at week 234. Official HARTS-to-MedDRA Mapping was used.
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2005
First Posted
October 12, 2005
Study Start
June 1, 2003
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
May 8, 2014
Results First Posted
July 3, 2009
Record last verified: 2014-04