Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission

PHASE3CompletedINTERVENTIONAL
Enrollment

371

Participants

Timeline

Start Date

February 20, 2015

Primary Completion Date

December 6, 2019

Study Completion Date

December 6, 2019

Conditions
Rheumatoid Arthritis
Interventions
DRUG

etanercept pre-filled syringe subcutaneous injection

etanercept for injection in pre-filled syringes

DRUG

Oral methotrexate

"During the open-label run-in period, methotrexate will be provided as 2.5 mg tablets.~During the double-blind treatment period, methotrexate will be provided as 2.5 mg capsules."

DRUG

Placebo for etanercept subcutaneous injection

etanercept placebo for injection in pre-filled syringes

DRUG

Placebo for methotrexate

methotrexate placebo capsules

DIETARY_SUPPLEMENT

Folic acid (non-investigational product)

Folic acid 5 to 7 mg per week as per investigator judgment or according to local standard of care.

Trial Locations (136)

1023

Research Site, Budapest

1036

Research Site, Budapest

1425

Research Site, Buenos Aires

1505

Research Site, Sofia

1612

Research Site, Sofia

1784

Research Site, Sofia

4000

Research Site, Plovdiv

4002

Research Site, Plovdiv

7500

Research Site, Panorama

8200

Research Site, Veszprém

10021

Research Site, New York

11021

Research Site, Great Neck

11201

Research Site, Brooklyn

11527

Research Site, Athens

12462

Research Site, Athens

14059

Research Site, Berlin

14561

Research Site, Athens

15006

Research Site, A Coruña

15224

Research Site, Pittsburgh

16635

Research Site, Duncansville

19096

Research Site, Wynnewood

19610

Research Site, Wyomissing

20902

Research Site, Wheaton

21100

Research Site, Mexicali

24541

Research Site, Danville

27834

Research Site, Greenville

28204

Research Site, Charlotte

28222

Research Site, Majadahonda

29118

Research Site, Orangeburg

29406

Research Site, Charleston

30046

Research Site, Lawrenceville

30120

Research Site, El Palmar

31000

Research Site, Chihuahua City

31134

Research Site, Hildesheim

32514

Research Site, Pensacola

32607

Research Site, Gainesville

32806

Research Site, Orlando

33076

Research Site, Bordeaux

33126

Research Site, Doral

Research Site, Miami

33144

Research Site, Miami

33309

Research Site, Fort Lauderdale

33613

Research Site, Tampa

33705

Research Site, St. Petersburg

34295

Research Site, Montpellier

34684

Research Site, Palm Harbor

35205

Research Site, Birmingham

35294

Research Site, Birmingham

35801

Research Site, Huntsville

37007

Research Site, Salamanca

37126

Research Site, Verona

38305

Research Site, Jackson

41009

Research Site, Seville

42123

Research Site, Reggio Emilia

44650

Research Site, Guadalajara

45067

Research Site, Orléans

46005

Research Site, Cahors

46017

Research Site, Valencia

46530

Research Site, Granger

48013

Research Site, Bilbao

48109

Research Site, Ann Arbor

48202

Research Site, Detroit

48910

Research Site, Lansing

48917

Research Site, Lansing

49008

Research Site, Kalamazoo

49546

Research Site, Grand Rapids

50139

Research Site, Florence

54636

Research Site, Thessaloniki

56429

Research Site, Thessaloniki

60076

Research Site, Skokie

60406

Research Site, Blue Island

60590

Research Site, Frankfurt am Main

62703

Research Site, Springfield

63141

Research Site, St Louis

64020

Research Site, Monterrey

65807

Research Site, Springfield

66346

Research Site, Püttlingen

70121

Research Site, New Orleans

70124

Research Site, Bari

70809

Research Site, Baton Rouge

71110

Research Site, Heraklion

73103

Research Site, Oklahoma City

75007

Research Site, Carrollton

75010

Research Site, Paris

75024

Research Site, Plano

77429

Research Site, Cypress

77573

Research Site, League City

77598

Research Site, Webster

78229

Research Site, San Antonio

78404

Research Site, Corpus Christi

80131

Research Site, Napoli

83642

Research Site, Meridian

83702

Research Site, Boise

85037

Research Site, Phoenix

85202

Research Site, Mesa

85258

Research Site, Scottsdale

85306

Research Site, Glendale

87102

Research Site, Albuquerque

90502

Research Site, Torrance

91307

Research Site, West Hills

92025

Research Site, Escondido

92037

Research Site, La Jolla

92335

Research Site, Fontana

92395

Research Site, Victorville

92543

Research Site, Hemet

92563

Research Site, Murrieta

92646

Research Site, Huntington Beach

92780

Research Site, Tustin

92868

Research Site, Orange

95124

Research Site, Catania

95817

Research Site, Sacramento

93454-6945

Research Site, Santa Maria

07012

Research Site, Clifton

07728

Research Site, Freehold

07103

Research Site, Newark

37909-1900

Research Site, Knoxville

R3N 0K6

Research Site, Winnipeg

B1S 3N1

Research Site, Sydney

L8N 1Y2

Research Site, Hamilton

H2L 1S6

Research Site, Montreal

G1V 3M7

Research Site, Québec

G5L 8W1

Research Site, Rimouski

G8Z 1Y2

Research Site, Trois-Rivières

128 50

Research Site, Prague

686 01

Research Site, Uherské Hradiště

04103

Research Site, Leipzig

00128

Research Site, Roma

85-168

Research Site, Bydgoszcz

52-200

Research Site, Karwiany

81-759

Research Site, Sopot

37-450

Research Site, Stalowa Wola

3000-075

Research Site, Coimbra

1050-034

Research Site, Lisbon

1649-035

Research Site, Lisbon

4990-041

Research Site, Ponte de Lima

08026

Research Site, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY