NCT00565409

Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

A Randomized, Double-Blind Study Comparing the Safety & Efficacy of Once-Weekly Etanercept 50 mg, Etanercept 25 mg, & Placebo in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 834 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with that of methotrexate monotherapy in the treatment of rheumatoid arthritis over 88 weeks.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Etanercept	Subcutaneous (SC), 50 mg, once weekly for 88 weeks
DRUG	Methotrexate	Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks. If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week).
DRUG	Etanercept	Subcutaneous (SC), 25 mg, once weekly from week 36 to week 88.
DRUG	Methotrexate	Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks. If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week).
DRUG	Placebo	Subcutaneous (SC), once weekly from week 36 to week 88.
DRUG	Methotrexate	Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks. If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week).

Timeline

• Start date: 2008-03-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2007-11-30
• Last updated: 2015-08-10
• Results posted: 2015-08-10

Locations

81 sites across 20 countries: Australia, Austria, Belgium, Chile, Colombia, Czechia, France, Germany, Hungary, Italy, Mexico, Netherlands, Poland, Russia, Serbia and Montenegro, South Korea, Spain, Sweden, Taiwan, United Kingdom