CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 834 enrolled
Drug / intervention
Etanercept +5 moredrug
Likely dose
Etanercept 50 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/NCT00565409
NCT00565409Phase 4Completed
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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

Pfizer·interventional·Posted Nov 30, 2007·Updated Aug 10, 2015

In Brief

A Phase 4 clinical trial evaluating Etanercept, Methotrexate, and 1 other intervention for Arthritis, Rheumatoid. Completed, enrolled 834 participants across 81 sites in 20 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
CountriesAustralia, Austria, Belgium, Chile, Colombia, Czechia, France, Germany, Hungary, Italy, Mexico, Netherlands, Poland, Russia, Serbia and Montenegro, South Korea, Spain, Sweden, Taiwan, United Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 30, 2007
Enrollment StartMar 1, 2008
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 18.6 years ago

Interventions

Etanerceptdrug

Subcutaneous (SC), 50 mg, once weekly for 88 weeks

Methotrexatedrug

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).

Etanerceptdrug

Subcutaneous (SC), 25 mg, once weekly from week 36 to week 88.

Methotrexatedrug

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).

Placebodrug

Subcutaneous (SC), once weekly from week 36 to week 88.

Methotrexatedrug

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).