Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis
NCT ID: NCT00959036
Last Updated: 2013-01-30
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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COMPLETED
PHASE1/PHASE2
252 participants
INTERVENTIONAL
2009-09-30
2011-01-31
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
QUADRUPLE
Study Groups
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Treatment Group 1
ATN-103 10 mg every 4 weeks until week 12
ATN-103
10 mg every 4 weeks until week 12
Methotrexate
Treatment Group 2
ATN-103 10 mg every 8 weeks until week 12
ATN-103
10 mg every 8 weeks until week 12
Methotrexate
Treatment Group 3
ATN-103 30 mg every 4 weeks until week 12
ATN-103
30 mg every 4 weeks until week 12
Methotrexate
Treatment Group 4
ATN-103 80 mg every 4 weeks until week 12
ATN-103
80 mg every 4 weeks until week 12
Methotrexate
Treatment Group 5
ATN-103 80 mg every 8 weeks until week 12
ATN-103
80 mg every 8 weeks until week 12
Methotrexate
Treatment Group 6
Placebo every 4 weeks
Placebo
Placebo every 4 weeks
Methotrexate
Interventions
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ATN-103
10 mg every 4 weeks until week 12
ATN-103
10 mg every 8 weeks until week 12
ATN-103
30 mg every 4 weeks until week 12
ATN-103
80 mg every 4 weeks until week 12
ATN-103
80 mg every 8 weeks until week 12
Placebo
Placebo every 4 weeks
Methotrexate
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Any clinically significant laboratory abnormalities
* Any prior use of B cell-depleting therapy
18 Years
80 Years
ALL
No
Sponsors
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Ablynx, a Sanofi company
INDUSTRY
Responsible Party
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Principal Investigators
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Josefin-Beate Holz, MD
Role: STUDY_DIRECTOR
Ablynx, a Sanofi company
Locations
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Investigational Site
Birmingham, Alabama, United States
Investigational Site
Huntsville, Alabama, United States
Investigational Site
Peoria, Arizona, United States
Investigational Site
Scottsdale, Arizona, United States
Investigational Site
Riverside, California, United States
Investigational Site
Upland, California, United States
Investigational Site
Bridgeport, Connecticut, United States
Investigational Site
Newark, Delaware, United States
Investigational Site
Lake Mary, Florida, United States
Investigational Site
Ocala, Florida, United States
Investigational Site
Orlando, Florida, United States
Investigational Site
Port Orange, Florida, United States
Investigational Site
Vero Beach, Florida, United States
Investigational Site
Coeur d'Alene, Idaho, United States
Investigational Site
Frederick, Maryland, United States
Investigational Site
West Yarmouth, Massachusetts, United States
Investigational Site
Lansing, Michigan, United States
Investigational Site
Freehold, New Jersey, United States
Investigational Site
Albuquerque, New Mexico, United States
Investigational Site
Mineola, New York, United States
Investigational Site
Charlotte, North Carolina, United States
Investigational Site
Hickory, North Carolina, United States
Investigational Site
Winston-Salem, North Carolina, United States
Investigational Site
Winston-Salem, North Carolina, United States
Investigational Site
Columbus, Ohio, United States
Investigational Site
Oklahoma City, Oklahoma, United States
Investigational Site
Oklahoma City, Oklahoma, United States
Investigational Site
Tulsa, Oklahoma, United States
Investigational Site
Lake Oswego, Oregon, United States
Investigational Site
Allentown, Pennsylvania, United States
Investigational Site
Columbia, South Carolina, United States
Investigational Site
Myrtle Beach, South Carolina, United States
Investigational Site
Nashville, Tennessee, United States
Investigational Site
Dallas, Texas, United States
Investigational Site
Houston, Texas, United States
Investigational Site
San Antonio, Texas, United States
Investigational Site
Tacoma, Washington, United States
Investigational Site
Brussels, Belgium, Belgium
Investigational Site
Leuven, , Belgium
Investigational Site
Winnipeg, Manitoba, Canada
Investigational Site
Kitchener, Ontario, Canada
Investigational Site
Ottawa, Ontario, Canada
Investigational Site
St. Catharines, Ontario, Canada
Investigational Site
Toronto, Ontario, Canada
Investigational Site
Québec, Quebec, Canada
Investigational Site
Vogelsang, Gommern, Germany
Investigational Site
Budapest, , Hungary
Investigational Site
Debrecen, , Hungary
Investigational Site
Kemerovo, , Russia
Investigational Site
Moscow, , Russia
Investigational Site
Moscow, , Russia
Investigational Site
Novosibirsk, , Russia
Investigational Site
Novosibirsk, , Russia
Investigational Site
Orenburg, , Russia
Investigational Site
Petrozavodsk, , Russia
Investigational Site
Ryazan, , Russia
Investigational Site
Vladimir, , Russia
Investigational Site
Yaroslavl, , Russia
Investigational Site
Yaroslavl, , Russia
Investigational Site
Belgrade, Serbia, Serbia
Investigational Site
Niška Banja, , Serbia
Investigational Site
Berea, KwaZulu-Natal, South Africa
Investigational Site
Cape Town, , South Africa
Investigational Site
Cape Town, , South Africa
Investigational Site
Pretoria, , South Africa
Investigational Site
Zurich, Canton of Zurich, Switzerland
Investigational Site
Chur, , Switzerland
Countries
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Other Identifiers
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B2271003
Identifier Type: -
Identifier Source: secondary_id
3242K1-2000
Identifier Type: -
Identifier Source: org_study_id
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