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Study Evaluating Long-Term Safety Of ATN-103 In Subjects With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01063803
Recruitment Status : Completed
First Posted : February 5, 2010
Last Update Posted : April 11, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
This open-label extension study will allow subjects who have completed either the 3242K1-2000-WW or 3242K1-2001-JA study to receive up to an additional 48 weeks of ATN-103 treatment and will provide data on the long-term safety and tolerability of ATN-103 in subjects with rheumatoid arthritis.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: ATN-103 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 266 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study To Assess The Long-term Safety And Tolerability Of ATN-103 In Subjects With Rheumatoid Arthritis
Study Start Date : February 2010
Primary Completion Date : February 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm 1: ATN-103_30mg Drug: ATN-103
A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study)
Experimental: Arm 2: ATN-103_80 mg Drug: ATN-103
A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study)

Outcome Measures

Primary Outcome Measures :
  1. Collection of safety data and assessments will include adverse events, treatment-emergent adverse events, injection site reactions, infections, vital signs and safety laboratory measurements. [ Time Frame: 18 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects must have completed study 3242K1-2000-WW or 3242K1-2001-JA and have had no events that, in the opinion of the investigator, would preclude entry or participation in this study.

Exclusion Criteria:

  • Pregnant or nursing women.
  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063803

  Hide Study Locations
United States, Alabama
Investigational Site
Birmingham, Alabama, United States, 35216
Investigational Site
Huntsville, Alabama, United States, 35801
United States, Arizona
Investigational Site
Peoria, Arizona, United States, 85381
United States, California
Investigational Site
Riverside, California, United States, 92501
Investigational Site
Upland, California, United States, 91786
United States, Connecticut
Investigational Site
Bridgeport, Connecticut, United States, 06606
United States, Delaware
Investigational Site
Newark, Delaware, United States, 19713
United States, Florida
Investigational Site
Ocala, Florida, United States, 34474
Investigational Site
Port Orange, Florida, United States, 32127
Investigational Site
Vero Beach, Florida, United States, 32960
United States, Idaho
Investigational Site
Coeur d'Alene, Idaho, United States, 83814
United States, Maryland
Investigational Site
Frederick, Maryland, United States, 21702
United States, Michigan
Investigational Site
Lansing, Michigan, United States, 48910
United States, New Jersey
Investigational Site
Freehold, New Jersey, United States, 07728
United States, North Carolina
Investigational Site
Charlotte, North Carolina, United States, 28210
Investigational Site
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Investigational Site
Columbus, Ohio, United States, 43213
United States, Oklahoma
Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Investigational Site
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Investigational Site
Lake Oswego, Oregon, United States, 97035
United States, South Carolina
Investigational Site
Columbia, South Carolina, United States, 29204
Investigational Site
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Investigational Site
Nashville, Tennessee, United States, 37205
United States, Texas
Investigational Site
Dallas, Texas, United States, 75231
Investigational Site
San Antonio, Texas, United States, 78217
Canada, Manitoba
Investigational Site
Winnipeg, Manitoba, Canada, R3A 1M3
Canada, Ontario
Investigational Site
Kitchener, Ontario, Canada, N2M 5N6
Investigational Site
St. Catharines, Ontario, Canada, L2N 7E4
Investigational Site
Toronto, Ontario, Canada, M9L 3A2
Investigational Site
Quebec, Canada, G1W 4R4
Investigational Site
Budapest, Hungary, 1023
Investigational Site
Budapest, Hungary, 1036
Investigational Site
Debrecen, Hungary, 4032
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
Kato, Hyogo, Japan
Investigational Site
Kumamoto-shi, Kumamoto, Japan
Investigational Site
Honmachi, Higashiyama, Kyoto, Japan
Investigational Site
Miyazaki-city, Miyazaki, Japan
Investigational Site
Nagano-shi, Nagano, Japan
Investigational Site
Yamato, Sasebo, Nagasaki, Japan
Investigational Site
Higashi-tyo, Kawachi Nagano, Osaka, Japan
Investigational Site
Ureshino-machi, Ureshino-shi, Saga, 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
Russian Federation
Investigational Site
Kemerovo, Russian Federation, 650066
Investigational Site
Moscow, Russian Federation, 115522
Investigational Site
Novosibirsk, Russian Federation, 630008
Investigational Site
Orenburg, Russian Federation, 460018
Investigational Site
Ryazan, Russian Federation, 390026
Investigational Site
Vladimir, Russian Federation, 600023
Investigational Site
Yaroslavl, Russian Federation, 150003
Investigational Site
Yaroslavl, Russian Federation, 150062
Investigational Site
Belgrade, Serbia, 11000
Investigational Site
Niska Banja, Serbia, 18205
South Africa
Investigational Site
Les Marais, Gauteng, South Africa, 0084
Investigational Site
Berea, KwaZulu-Natal, South Africa, 4001
Investigational Site
Panorama, Western Cape, South Africa, 7500
Investigational Site
Pinelands, Western Cape, South Africa, 7405
Investigational Site
Chur, Switzerland, 7000
Sponsors and Collaborators
Study Director: Medical Director, MD Ablynx NV
More Information

Responsible Party: Ablynx
ClinicalTrials.gov Identifier: NCT01063803     History of Changes
Other Study ID Numbers: 3242K1-2003
First Posted: February 5, 2010    Key Record Dates
Last Update Posted: April 11, 2016
Last Verified: January 2013

Keywords provided by Ablynx:
Long-term safety study of ATN-103 in RA

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases