CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 300 enrolled
Drug / intervention
Etanercept , Methotrexate +1 moredrug
Likely dose
Etanercept , Methotrexate 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00422227
NCT00422227Phase 4Completed
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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

Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Jan 15, 2007·Updated Aug 30, 2010

In Brief

A Phase 4 clinical trial evaluating Etanercept , Methotrexate and Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide for Rheumatoid Arthritis. Completed, enrolled 300 participants across 27 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesHong Kong, India, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 15, 2007
Enrollment StartJun 1, 2007
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.5 years ago

Interventions

Etanercept , Methotrexatedrug

* Etanercept: 25 mg twice weekly over 16 weeks, SC * Methotrexate: \> 7.5 mg/week and no more than 25 mg/week, PO

Methotrexate; sulfasalazine; hydroxychloroquine;leflunomidedrug

* 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