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

NCT01063803 | Completed Phase 2

• 2 other identifiers: 3242K1-2003B2271005
• Study Type: interventional
• Target: 266
• Locations: 8 countries
• Sites: 67

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.

Conditions

Rheumatoid Arthritis

Keywords

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

Outcome Measures

Primary Outcomes (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.

  18 months

Study Arms (2)

Arm 1: ATN-103_30mg

EXPERIMENTAL

Drug: ATN-103

Arm 2: ATN-103_80 mg

EXPERIMENTAL

Drug: ATN-103

Interventions

ATN-103 DRUG

A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study)

Arm 1: ATN-103_30mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ablynx, a Sanofi company: lead

Study Sites (67)

Investigational Site

Birmingham, Alabama, 35216, United States

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Huntsville, Alabama, 35801, United States

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Peoria, Arizona, 85381, United States

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Riverside, California, 92501, United States

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Upland, California, 91786, United States

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Bridgeport, Connecticut, 06606, United States

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Newark, Delaware, 19713, United States

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Ocala, Florida, 34474, United States

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Port Orange, Florida, 32127, United States

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Vero Beach, Florida, 32960, United States

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Coeur d'Alene, Idaho, 83814, United States

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Frederick, Maryland, 21702, United States

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Lansing, Michigan, 48910, United States

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Freehold, New Jersey, 07728, United States

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Charlotte, North Carolina, 28210, United States

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Winston-Salem, North Carolina, 27157, United States

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Columbus, Ohio, 43213, United States

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Oklahoma City, Oklahoma, 73103, United States

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Tulsa, Oklahoma, 74104, United States

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Lake Oswego, Oregon, 97035, United States

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Columbia, South Carolina, 29204, United States

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Myrtle Beach, South Carolina, 29572, United States

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Nashville, Tennessee, 37205, United States

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Dallas, Texas, 75231, United States

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San Antonio, Texas, 78217, United States

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Winnipeg, Manitoba, R3A 1M3, Canada

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Kitchener, Ontario, N2M 5N6, Canada

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St. Catharines, Ontario, L2N 7E4, Canada

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Toronto, Ontario, M9L 3A2, Canada

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Québec, Quebec, G1W 4R4, Canada

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Budapest, 1023, Hungary

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Budapest, 1036, Hungary

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Debrecen, 4032, Hungary

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Nitona-cho, Chuoh-ku, Chiba-shi, Chiba, Japan

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Bunkyoucho, Matsuyama, Ehime, Japan

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Chuoh-ku, Fukuoka-shi, Fukuoka, Japan

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Kurume, Fukuoka, Japan

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Yoshio-machi Iizuka-shi, Fukuoka, Japan

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Tohrimachi, Takasaki, Gunma, Japan

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Katō, Hyōgo, Japan

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Kumamoto, Kumamoto, Japan

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Honmachi, Higashiyama, Kyoto, Japan

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Miyazaki, Miyazaki, Japan

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Nagano, Nagano, Japan

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Yamato, Sasebo, Nagasaki, Japan

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Higashi-tyo, Kawachi Nagano, Osaka, Japan

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Ureshino-machi, Ureshino-shi, Saga-ken, Japan

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Kawagoe, Saitama, Japan

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Midori-cho 2 Chome Tokorozawa-shi, Saitama, Japan

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Kawada-cho, Shinjyuku-ku, Tokyo, Japan

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Shinanomachi, Shinjuku, Tokyo, Japan

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Takaoka-shi, Toyama, Japan

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Kemerovo, 650066, Russia

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Moscow, 115522, Russia

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Novosibirsk, 630008, Russia

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Orenburg, 460018, Russia

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Ryazan, 390026, Russia

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Vladimir, 600023, Russia

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Yaroslavl, 150003, Russia

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Yaroslavl, 150062, Russia

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Belgrade, Serbia, 11000, Serbia

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Niška Banja, 18205, Serbia

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Les Marais, Gauteng, 0084, South Africa

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Berea, KwaZulu-Natal, 4001, South Africa

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Panorama, Western Cape, 7500, South Africa

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Pinelands, Western Cape, 7405, South Africa

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Chur, 7000, Switzerland

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Director, MD

  Ablynx NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 5, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 11, 2016

Record last verified: 2013-01

Locations

CA (5); SE (2); JP (19); RU (8); ZA (4); HU (3); US (25); CH (1)