NCT00959036

Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis

A Seamless, Phase 1/2, Multiple Ascending Dose, Proof Of Concept Study Of ATN-103 Administered To Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: Ablynx, a Sanofi company · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of ATN-103 when administered to subjects with active rheumatoid arthritis compared with placebo. All subjects must be on a stable dose and route of methotrexate.

Conditions

• Active Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	ATN-103	10 mg every 4 weeks until week 12
DRUG	ATN-103	10 mg every 8 weeks until week 12
DRUG	ATN-103	30 mg every 4 weeks until week 12
DRUG	ATN-103	80 mg every 4 weeks until week 12
DRUG	ATN-103	80 mg every 8 weeks until week 12
DRUG	Placebo	Placebo every 4 weeks
DRUG	Methotrexate

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2009-08-14
• Last updated: 2013-01-30

Locations

67 sites across 9 countries: United States, Belgium, Canada, Germany, Hungary, Russia, Serbia, South Africa, Switzerland