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

Rheumatoid Arthritis Clinical Trial

Official title:

An Open-Label Extension Study To Assess The Long-term Safety And Tolerability Of ATN-103 In Subjects With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01063803
• Other study ID #: 3242K1-2003
• Secondary ID: B2271005
• Status: Completed
• Phase: Phase 2
• First received: February 2, 2010
• Last updated: January 30, 2013
• Start date: February 2010
• Est. completion date: February 2012

Study information

• Verified date: January 2013
• Source: Ablynx
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
Canada	Investigational Site	Kitchener	Ontario
Canada	Investigational Site	Quebec
Canada	Investigational Site	St. Catharines	Ontario
Canada	Investigational Site	Toronto	Ontario
Canada	Investigational Site	Winnipeg	Manitoba
Hungary	Investigational Site	Budapest
Hungary	Investigational Site	Budapest
Hungary	Investigational Site	Debrecen
Japan	Investigational Site	Bunkyoucho, Matsuyama	Ehime
Japan	Investigational Site	Chuoh-ku, Fukuoka-shi	Fukuoka
Japan	Investigational Site	Higashi-tyo, Kawachi Nagano	Osaka
Japan	Investigational Site	Honmachi, Higashiyama	Kyoto
Japan	Investigational Site	Kato	Hyogo
Japan	Investigational Site	Kawada-cho, Shinjyuku-ku	Tokyo
Japan	Investigational Site	Kawagoe	Saitama
Japan	Investigational Site	Kumamoto-shi	Kumamoto
Japan	Investigational Site	Kurume	Fukuoka
Japan	Investigational Site	Midori-cho 2 chome Tokorozawa-shi	Saitama
Japan	Investigational Site	Miyazaki-city	Miyazaki
Japan	Investigational Site	Nagano-shi	Nagano
Japan	Investigational Site	Nitona-cho, Chuoh-ku, Chiba-shi	Chiba
Japan	Investigational Site	Shinanomachi, Shinjuku	Tokyo
Japan	Investigational Site	Takaoka-shi	Toyama
Japan	Investigational Site	Tohrimachi, Takasaki	Gunma
Japan	Investigational Site	Ureshino-machi, Ureshino-shi	Saga
Japan	Investigational Site	Yamato, Sasebo	Nagasaki
Japan	Investigational Site	Yoshio-machi Iizuka-shi	Fukuoka
Russian Federation	Investigational Site	Kemerovo
Russian Federation	Investigational Site	Moscow
Russian Federation	Investigational Site	Novosibirsk
Russian Federation	Investigational Site	Orenburg
Russian Federation	Investigational Site	Ryazan
Russian Federation	Investigational Site	Vladimir
Russian Federation	Investigational Site	Yaroslavl
Russian Federation	Investigational Site	Yaroslavl
Serbia	Investigational Site	Belgrade
Serbia	Investigational Site	Niska Banja
South Africa	Investigational Site	Berea	KwaZulu-Natal
South Africa	Investigational Site	Les Marais	Gauteng
South Africa	Investigational Site	Panorama	Western Cape
South Africa	Investigational Site	Pinelands	Western Cape
Switzerland	Investigational Site	Chur
United States	Investigational Site	Birmingham	Alabama
United States	Investigational Site	Bridgeport	Connecticut
United States	Investigational Site	Charlotte	North Carolina
United States	Investigational Site	Coeur d'Alene	Idaho
United States	Investigational Site	Columbia	South Carolina
United States	Investigational Site	Columbus	Ohio
United States	Investigational Site	Dallas	Texas
United States	Investigational Site	Frederick	Maryland
United States	Investigational Site	Freehold	New Jersey
United States	Investigational Site	Huntsville	Alabama
United States	Investigational Site	Lake Oswego	Oregon
United States	Investigational Site	Lansing	Michigan
United States	Investigational Site	Myrtle Beach	South Carolina
United States	Investigational Site	Nashville	Tennessee
United States	Investigational Site	Newark	Delaware
United States	Investigational Site	Ocala	Florida
United States	Investigational Site	Oklahoma City	Oklahoma
United States	Investigational Site	Peoria	Arizona
United States	Investigational Site	Port Orange	Florida
United States	Investigational Site	Riverside	California
United States	Investigational Site	San Antonio	Texas
United States	Investigational Site	Tulsa	Oklahoma
United States	Investigational Site	Upland	California
United States	Investigational Site	Vero Beach	Florida
United States	Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ablynx

Countries where clinical trial is conducted

United States,  Canada,  Hungary,  Japan,  Russian Federation,  Serbia,  South Africa,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes