Study Evaluating Long-Term Safety Of ATN-103 In Subjects With Rheumatoid Arthritis
NCT ID: NCT01063803
Last Updated: 2016-04-11
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
PHASE2
266 participants
INTERVENTIONAL
2010-02-28
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: ATN-103_30mg
ATN-103
A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study)
Arm 2: ATN-103_80 mg
ATN-103
A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study)
Interventions
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ATN-103
A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study)
ATN-103
A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, cardiovascular, hematological, gastrointestinal, endocrine, pulmonary, immunologic \[eg, Felty syndrome, human immunodeficiency virus (HIV) infection\], infectious, neurological, or cerebral psychiatric disease, or evidence of demyelinating disease) that, in the investigator's judgment, will substantially increase the risk associated with the subject's developing an adverse event (AE) or serious adverse event (SAE) during the study, or preclude the evaluation of the subject's response.
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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Medical Director, MD
Role: STUDY_DIRECTOR
Ablynx NV
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
Riverside, California, United States
Investigational Site
Upland, California, United States
Investigational Site
Bridgeport, Connecticut, United States
Investigational Site
Newark, Delaware, United States
Investigational Site
Ocala, 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
Lansing, Michigan, United States
Investigational Site
Freehold, New Jersey, United States
Investigational Site
Charlotte, 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
Tulsa, Oklahoma, United States
Investigational Site
Lake Oswego, Oregon, 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
San Antonio, Texas, United States
Investigational Site
Winnipeg, Manitoba, Canada
Investigational Site
Kitchener, Ontario, Canada
Investigational Site
St. Catharines, Ontario, Canada
Investigational Site
Toronto, Ontario, Canada
Investigational Site
Québec, Quebec, Canada
Investigational Site
Budapest, , Hungary
Investigational Site
Budapest, , Hungary
Investigational Site
Debrecen, , Hungary
Investigational Site
Nitona-cho, Chuoh-ku, Chiba-shi, Chiba, Japan
Investigational Site
Bunkyoucho, Matsuyama, Ehime, Japan
Investigational Site
Chuoh-ku, Fukuoka-shi, Fukuoka, Japan
Investigational Site
Kurume, Fukuoka, Japan
Investigational Site
Yoshio-machi Iizuka-shi, Fukuoka, Japan
Investigational Site
Tohrimachi, Takasaki, Gunma, Japan
Investigational Site
Katō, Hyōgo, Japan
Investigational Site
Kumamoto, Kumamoto, Japan
Investigational Site
Honmachi, Higashiyama, Kyoto, Japan
Investigational Site
Miyazaki, Miyazaki, Japan
Investigational Site
Nagano, Nagano, Japan
Investigational Site
Yamato, Sasebo, Nagasaki, Japan
Investigational Site
Higashi-tyo, Kawachi Nagano, Osaka, Japan
Investigational Site
Ureshino-machi, Ureshino-shi, Saga-ken, Japan
Investigational Site
Kawagoe, Saitama, Japan
Investigational Site
Midori-cho 2 Chome Tokorozawa-shi, Saitama, Japan
Investigational Site
Kawada-cho, Shinjyuku-ku, Tokyo, Japan
Investigational Site
Shinanomachi, Shinjuku, Tokyo, Japan
Investigational Site
Takaoka-shi, Toyama, Japan
Investigational Site
Kemerovo, , Russia
Investigational Site
Moscow, , Russia
Investigational Site
Novosibirsk, , Russia
Investigational Site
Orenburg, , 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
Les Marais, Gauteng, South Africa
Investigational Site
Berea, KwaZulu-Natal, South Africa
Investigational Site
Panorama, Western Cape, South Africa
Investigational Site
Pinelands, Western Cape, South Africa
Investigational Site
Chur, , Switzerland
Countries
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Other Identifiers
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B2271005
Identifier Type: -
Identifier Source: secondary_id
3242K1-2003
Identifier Type: -
Identifier Source: org_study_id
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