NCT01063803

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 266 (actual)
• Sponsor: Ablynx, a Sanofi company · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	ATN-103	A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study)
DRUG	ATN-103	A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study)

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2010-02-05
• Last updated: 2016-04-11

Locations

67 sites across 8 countries: United States, Canada, Hungary, Japan, Russia, Serbia, South Africa, Switzerland