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

Purpose

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	Intervention	Phase
Rheumatoid Arthritis	Drug: ATN-103	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by Ablynx:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Enrollment:	266
Study Start Date:	February 2010
Study Completion Date:	February 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063803

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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
Canada
Investigational Site
Quebec, Canada, G1W 4R4
Hungary
Investigational Site
Budapest, Hungary, 1023
Investigational Site
Budapest, Hungary, 1036
Investigational Site
Debrecen, Hungary, 4032
Japan
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
Serbia
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
Switzerland
Investigational Site
Chur, Switzerland, 7000

Sponsors and Collaborators

Ablynx

Investigators

Study Director:

Josefin-Beate Holz, MD

Ablynx NV

More Information

No publications provided

Responsible Party:	Ablynx
ClinicalTrials.gov Identifier:	NCT01063803 History of Changes
Other Study ID Numbers:	3242K1-2003, B2271005
Study First Received:	February 2, 2010
Last Updated:	January 30, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ablynx:

Open-label
Long-term safety study of ATN-103 in RA

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases

Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013