Rheumatoid Arthritis
Conditions
Keywords
Open-label, Long-term safety study of ATN-103 in RA
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.
Interventions
DRUGATN-103
A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study)
Sponsors
Ablynx, a Sanofi company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada, Hungary, Japan, Russia, Serbia, South Africa, Switzerland, United States
Outcome results
None listed