Clinical trial NCT01063803: Study Evaluating Long-Term Safety Of ATN-103 In Subjects With Rheumatoid Arthritis
Official title: An Open-Label Extension Study To Assess The Long-term Safety And Tolerability Of ATN-103 In Subjects With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Open-label
Long-term safety study of ATN-103 in RA
Lead sponsor: Ablynx, a Sanofi company
Sponsor class: INDUSTRY
First posted: 2010-02-05
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Collection of safety data and assessments will include adverse events, treatment-emergent adverse events, injection site reactions, infections, vital signs and safety laboratory measurements.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: Investigational Site
state: Alabama
city: Peoria
country: United States
facility: Investigational Site
state: Arizona
city: Riverside
country: United States
facility: Investigational Site
state: California
city: Upland
country: United States
facility: Investigational Site
state: California
city: Bridgeport
country: United States
facility: Investigational Site
state: Connecticut
city: Newark
country: United States
facility: Investigational Site
state: Delaware
city: Ocala
country: United States
facility: Investigational Site
state: Florida
city: Port Orange
country: United States
facility: Investigational Site
state: Florida
city: Vero Beach
country: United States
facility: Investigational Site
state: Florida
city: Coeur d'Alene
country: United States
facility: Investigational Site
state: Idaho
city: Frederick
country: United States
facility: Investigational Site
state: Maryland
city: Lansing
country: United States
facility: Investigational Site
state: Michigan
city: Freehold
country: United States
facility: Investigational Site
state: New Jersey
city: Charlotte
country: United States
facility: Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Investigational Site
state: Oklahoma
city: Lake Oswego
country: United States
facility: Investigational Site
state: Oregon
city: Columbia
country: United States
facility: Investigational Site
state: South Carolina
city: Myrtle Beach
country: United States
facility: Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Investigational Site
state: Texas
city: Winnipeg
country: Canada
facility: Investigational Site
state: Manitoba
city: Kitchener
country: Canada
facility: Investigational Site
state: Ontario
city: St. Catharines
country: Canada
facility: Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site
state: Ontario
city: Quebec
country: Canada
facility: Investigational Site
city: Budapest
country: Hungary
facility: Investigational Site
city: Budapest
country: Hungary
facility: Investigational Site
city: Debrecen
country: Hungary
facility: Investigational Site
city: Nitona-cho, Chuoh-ku, Chiba-shi
country: Japan
facility: Investigational Site
state: Chiba
city: Bunkyoucho, Matsuyama
country: Japan
facility: Investigational Site
state: Ehime
city: Chuoh-ku, Fukuoka-shi
country: Japan
facility: Investigational Site
state: Fukuoka
city: Kurume
country: Japan
facility: Investigational Site
state: Fukuoka
city: Yoshio-machi Iizuka-shi
country: Japan
facility: Investigational Site
state: Fukuoka
city: Tohrimachi, Takasaki
country: Japan
facility: Investigational Site
state: Gunma
city: Kato
country: Japan
facility: Investigational Site
state: Hyogo
city: Kumamoto-shi
country: Japan
facility: Investigational Site
state: Kumamoto
city: Honmachi, Higashiyama
country: Japan
facility: Investigational Site
state: Kyoto
city: Miyazaki-city
country: Japan
facility: Investigational Site
state: Miyazaki
city: Nagano-shi
country: Japan
facility: Investigational Site
state: Nagano
city: Yamato, Sasebo
country: Japan
facility: Investigational Site
state: Nagasaki
city: Higashi-tyo, Kawachi Nagano
country: Japan
facility: Investigational Site
state: Osaka
city: Ureshino-machi, Ureshino-shi
country: Japan
facility: Investigational Site
state: Saga
city: Kawagoe
country: Japan
facility: Investigational Site
state: Saitama
city: Midori-cho 2 chome Tokorozawa-shi
country: Japan
facility: Investigational Site
state: Saitama
city: Kawada-cho, Shinjyuku-ku
country: Japan
facility: Investigational Site
state: Tokyo
city: Shinanomachi, Shinjuku
country: Japan
facility: Investigational Site
state: Tokyo
city: Takaoka-shi
country: Japan
facility: Investigational Site
state: Toyama
city: Kemerovo
country: Russian Federation
facility: Investigational Site
city: Moscow
country: Russian Federation
facility: Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Investigational Site
city: Orenburg
country: Russian Federation
facility: Investigational Site
city: Ryazan
country: Russian Federation
facility: Investigational Site
city: Vladimir
country: Russian Federation
facility: Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Investigational Site
city: Belgrade
country: Serbia
facility: Investigational Site
city: Niska Banja
country: Serbia
facility: Investigational Site
city: Les Marais
country: South Africa
facility: Investigational Site
state: Gauteng
city: Berea
country: South Africa
facility: Investigational Site
state: KwaZulu-Natal
city: Panorama
country: South Africa
facility: Investigational Site
state: Western Cape
city: Pinelands
country: South Africa
facility: Investigational Site
state: Western Cape
city: Chur
country: Switzerland
facility: Investigational Site
Study officials:
affiliation: Ablynx NV
name: Medical Director, MD
role: STUDY_DIRECTOR
References: