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

Ablynx

Status and phase

Completed

Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Drug: ATN-103

Study type

Interventional

Funder types

Industry

Identifiers

NCT01063803

3242K1-2003

B2271005

Details and patient eligibility

About

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.

Enrollment

266 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.