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

Completed · Phase 2

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT01063803

Run by

Ablynx, a Sanofi company

People needed

266

Starts

2010-02-01

Expected to finish

2012-02-01

Last updated by the study team

2016-04-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Investigational Site — Huntsville, Alabama, United States
• Investigational Site — Peoria, Arizona, United States
• Investigational Site — Riverside, California, United States
• Investigational Site — Upland, California, United States
• Investigational Site — Bridgeport, Connecticut, United States
• Investigational Site — Newark, Delaware, United States
• Investigational Site — Ocala, Florida, United States
• Investigational Site — Port Orange, Florida, United States
• Investigational Site — Vero Beach, Florida, United States
• Investigational Site — Coeur d'Alene, Idaho, United States
• Investigational Site — Frederick, Maryland, United States
• Investigational Site — Lansing, Michigan, United States
• Investigational Site — Freehold, New Jersey, United States
• Investigational Site — Charlotte, North Carolina, United States
• Investigational Site — Winston-Salem, North Carolina, United States
• Investigational Site — Columbus, Ohio, United States
• Investigational Site — Oklahoma City, Oklahoma, United States
• Investigational Site — Tulsa, Oklahoma, United States
• Investigational Site — Lake Oswego, Oregon, United States
• Investigational Site — Columbia, South Carolina, United States
• Investigational Site — Myrtle Beach, South Carolina, United States
• Investigational Site — Nashville, Tennessee, United States
• Investigational Site — Dallas, Texas, United States
• Investigational Site — San Antonio, Texas, United States
• Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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