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

PHASE4CompletedINTERVENTIONAL
Enrollment

834

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

May 31, 2011

Study Completion Date

May 31, 2011

Conditions
Arthritis, Rheumatoid
Interventions
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)."

Trial Locations (81)

114

Pfizer Investigational Site, Tapei City

807

Pfizer Investigational Site, Kaohsiung City

1023

Pfizer Investigational Site, Budapest

1130

Pfizer Investigational Site, Vienna

1200

Pfizer Investigational Site, Brussels

2194

Pfizer Investigational Site, Campsie

2217

Pfizer Investigational Site, Kogarah

3081

Pfizer Investigational Site, Heidelberg West

3145

Pfizer Investigational Site, Malvern

4000

Pfizer Investigational Site, Liège

4012

Pfizer Investigational Site, Debrecen

4103

Pfizer Investigational Site, Leipzig

4558

Pfizer Investigational Site, Maroochydore

5041

Pfizer Investigational Site, Daw Park

5530

Pfizer Investigational Site, Yvoir

6100

Pfizer Investigational Site, Victoria Park

9701

Pfizer Investigational Site, Szombathely

10043

Pfizer Investigational Site, Orbassano

10117

Pfizer Investigational Site, Berlin

11000

Pfizer Investigational Site, Belgrade

11500

Pfizer Investigational Site, Mexico City

15006

Pfizer Investigational Site, A Coruña

18205

Pfizer Investigational Site, Niska Banja

22081

Pfizer Investigational Site, Eilbek

29009

Pfizer Investigational Site, Málaga

31059

Pfizer Investigational Site, Toulouse

31392

Pfizer Investigational Site, Oskarström

34059

Pfizer Investigational Site, Montpellier

41009

Pfizer Investigational Site, Seville

44650

Pfizer Investigational Site, Guadalajara

50937

Pfizer Investigational Site, Cologne

64020

Pfizer Investigational Site, Monterrey

67098

Pfizer Investigational Site, Strasbourg

72037

Pfizer Investigational Site, Le Mans

75018

Pfizer Investigational Site, Paris

76000

Pfizer Investigational Site, Querétaro

79182

Pfizer Investigational Site, Falun

79201

Pfizer Investigational Site, Bruntál

Pfizer Investigational Site, Bruntál

91100

Pfizer Investigational Site, Corbeil-Essonnes

94270

Pfizer Investigational Site, Le Kremlin-Bicêtre

95100

Pfizer Investigational Site, Catania

97000

Pfizer Investigational Site, Mérida

97080

Pfizer Investigational Site, Würzburg

115522

Pfizer Investigational Site, Moscow

119002

Pfizer Investigational Site, Moscow

129110

Pfizer Investigational Site, Moscow

194291

Pfizer Investigational Site, Saint Petersburg

199004

Pfizer Investigational Site, Saint Petersburg

Unknown

Pfizer Investigational Site, Santiago

Pfizer Investigational Site, Barranquilla

Pfizer Investigational Site, Bogota

Pfizer Investigational Site, Warsaw

Pfizer Investigational Site, Moscow

760 01

Pfizer Investigational Site, Zlín

656 91

Pfizer Investigational Site, Brno

792 01

Pfizer Investigational Site, Bruntál

128 50

Pfizer Investigational Site, Prague

150 06

Pfizer Investigational Site, Prague

06202

Pfizer Investigational Site, Nice

04103

Pfizer Investigational Site, Leipzig

H-4032

Pfizer Investigational Site, Debrecen

00128

Pfizer Investigational Site, Roma

06700

Pfizer Investigational Site, Mexico City

6419 PC

Pfizer Investigational Site, Heerlen

85-168

Pfizer Investigational Site, Bydgoszcz

93-513

Pfizer Investigational Site, Lodz

20-954

Pfizer Investigational Site, Lublin

71-252

Pfizer Investigational Site, Szczecin

302-799

Pfizer Investigational Site, Seo-gu

405-760

Pfizer Investigational Site, Namdong-gu

135-720

Pfizer Investigational Site, Seoul

133-792

Pfizer Investigational Site, Seongdong-gu

431-070

Pfizer Investigational Site, Anyang-si Gyeonggi-do

134-701

Pfizer Investigational Site, Seoul

143-729

Pfizer Investigational Site, Seoul

157 06

Pfizer Investigational Site, Santiago de Compostela

08036

Pfizer Investigational Site, Barcelona

08208

Pfizer Investigational Site, Sabadell

WN6 9EP

Pfizer Investigational Site, Wigan

DY1 2HQ

Pfizer Investigational Site, Dudley

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY