NCT00422227

Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region

A Randomized, Open-Label Study in the Asia-Pacific Region Comparing the Safety and Efficacy of Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy of etanercept with usual disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Etanercept , Methotrexate	* Etanercept: 25 mg twice weekly over 16 weeks, SC * Methotrexate: \> 7.5 mg/week and no more than 25 mg/week, PO
DRUG	Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide	* Methotrexate: at least 7.5 mg/wk and not more than 25 mg/wk.;PO * Sulfasalazine: Start treatment w/500 mg daily for 1 wk, thereafter increase dose by 1 tab each wk to a max of 3 g/day;PO * Hydroxychloroquine:400 mg daily in divided dose, may be reduced to 200 mg. Max: 6.5 mg/kg/day * Leflunomide: Initially, loading dose 100 mg daily for 3 days. Maintenance: 20 mg daily

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2007-01-15
• Last updated: 2010-08-30
• Results posted: 2010-08-30

Locations

27 sites across 8 countries: Hong Kong, India, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand