BG9924 in Combination With Methotrexate for Participants With Active Rheumatoid Arthritis
NCT ID: NCT00458861
Last Updated: 2016-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
115 participants
INTERVENTIONAL
2007-03-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BG9924
Subcutaneous administration of BG9924 given every other week for 12 weeks
BG9924
Subcutaneous administration of BG9924 given every other week for 12 weeks
Placebo
Subcutaneous administration of placebo given every other week for 12 weeks
Placebo Comparator
Subcutaneous administration of placebo given every other week for 12 weeks
Interventions
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BG9924
Subcutaneous administration of BG9924 given every other week for 12 weeks
Placebo Comparator
Subcutaneous administration of placebo given every other week for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Methotrexate (10 mg/week to 25 mg/week) \> 3 months prior to Day 0 (stable dose \> 4 weeks prior to Day 0)
* Must have had an inadequate response to anti-TNF therapy due to inadequate efficacy
Exclusion Criteria
* Serious local infection or systemic infection within 3 months of Day 0
* History (Hx) of recurrent infections requiring oral or parental anti-infective treatment
* Hx of tuberculosis (TB) or positive purified protein derivative (PPD) test during the screening period
Laboratory Tests
* Clinically significant lab tests at screening; or
* Positive for hepatitis C antibody or hepatitis B at screening
18 Years
75 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Stanford University
Palo Alto, California, United States
Countries
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Other Identifiers
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2006-005467-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
104RA203
Identifier Type: -
Identifier Source: org_study_id
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