Study of the Optimal Protocol for Methotrexate and Adalimumab Combination Therapy in Early Rheumatoid Arthritis

PHASE4CompletedINTERVENTIONAL
Enrollment

1,032

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

July 31, 2010

Study Completion Date

July 31, 2010

Conditions
Rheumatoid Arthritis
Interventions
BIOLOGICAL

adalimumab

Adalimumab 40 mg/0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)

DRUG

methotrexate

Methotrexate 2.5 mg tablets administered orally once a week starting at 7.5 mg/week with dose escalation (weekly or every other week) by 2.5 mg intervals to 20 mg/week.

BIOLOGICAL

placebo

Placebo for adalimumab 0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)

Trial Locations (170)

1023

Site Reference ID/Investigator# 3921, Budapest

1090

Site Reference ID/Investigator# 3880, Vienna

1100

Site Reference ID/Investigator# 3885, Vienna

1130

Site Reference ID/Investigator# 3916, Vienna

1160

Site Reference ID/Investigator# 7792, Vienna

1200

Site Reference ID/Investigator# 3914, Brussels

1277

Site Reference ID/Investigator# 3922, Budapest

2013

Site Reference ID/Investigator# 7174, Soweto

2194

Site Reference ID/Investigator# 8380, Campsie, Sydney

2800

Site Reference ID/Investigator# 6720, Mechelen

3145

Site Reference ID/Investigator# 6940, Malvern East

3168

Site Reference ID/Investigator# 6954, Clayton

3600

Site Reference ID/Investigator# 3909, Genk

4000

Site Reference ID/Investigator# 3376, Liège

4001

Site Reference ID/Investigator# 7177, Berea, Durban

4012

Site Reference ID/Investigator# 3920, Debrecen

4615

Site Reference ID/Investigator# 7935, Kristiansand

5530

Site Reference ID/Investigator# 3910, Yvoir

6045

Site Reference ID/Investigator# 7176, Port Elizabeth

6060

Site Reference ID/Investigator# 3881, Gilly

7405

Site Reference ID/Investigator# 7175, Cape Town

7500

Site Reference ID/Investigator# 7178, Cape Town

7600

Site Reference ID/Investigator# 7506, Levanger

8036

Site Reference ID/Investigator# 3915, Graz

9100

Site Reference ID/Investigator# 6718, Sint-Niklaas

10461

Site Reference ID/Investigator# 12821, The Bronx

10700

Site Reference ID/Investigator# 3825, Mexico City

Site Reference ID/Investigator# 3951, Mexico City

11787

Site Reference ID/Investigator# 4600, Smithtown

11803

Site Reference ID/Investigator# 9324, Plainview

13125

Site Reference ID/Investigator# 3928, Buch

14127

Site Reference ID/Investigator# 4534, Orchard Park

14389

Site Reference ID/Investigator# 3890, Mexico City

15006

Site Reference ID/Investigator# 3955, A Coruña

15090

Site Reference ID/Investigator# 4558, Wexford

15706

Site Reference ID/Investigator# 3954, Santiago de Compostela

16635

Site Reference ID/Investigator# 4546, Duncansville

20230

Site Reference ID/Investigator# 3824, Aguascallentes

20502

Site Reference ID/Investigator# 4016, Malmo

20902

Site Reference ID/Investigator# 10741, Wheaton

20954

Site Reference ID/Investigator# 5560, Lublin

24351

Site Reference ID/Investigator# 3978, Damp

28006

Site Reference ID/Investigator# 8524, Madrid

28007

Site Reference ID/Investigator# 3956, Madrid

28034

Site Reference ID/Investigator# 3943, Madrid

28046

Site Reference ID/Investigator# 3931, Madrid

29406

Site Reference ID/Investigator# 4533, Charleston

29601

Site Reference ID/Investigator# 7482, Greenville

32073

Site Reference ID/Investigator# 9325, Orange Park

32746

Site Reference ID/Investigator# 10603, Lake Mary

32960

Site Reference ID/Investigator# 4552, Vero Beach

33006

Site Reference ID/Investigator# 3957, Oviedo

33180

Site Reference ID/Investigator# 6229, Aventura

33614

Site Reference ID/Investigator# 4601, Tampa

34239

Site Reference ID/Investigator# 4570, Sarasota

34684

Site Reference ID/Investigator# 4550, Palm Harbor

35205

Site Reference ID/Investigator# 4560, Birmingham

35406

Site Reference ID/Investigator# 6758, Tuscaloosa

35801

Site Reference ID/Investigator# 6222, Huntsville

36608

Site Reference ID/Investigator# 4537, Mobile

37000

Site Reference ID/Investigator# 3822, León

37205

Site Reference ID/Investigator# 4562, Nashville

38305

Site Reference ID/Investigator# 10743, Jackson

39245

Site Reference ID/Investigator# 3919, Vogelsang-Gommern

39261

Site Reference ID/Investigator# 6637, Zerbst

40225

Site Reference ID/Investigator# 3924, Düsseldorf

40635

Site Reference ID/Investigator# 3962, Katowice

40882

Site Reference ID/Investigator# 8486, Ratingen

44143

Site Reference ID/Investigator# 4549, Mayfield Village

48013

Site Reference ID/Investigator# 13661, Bilbao

50009

Site Reference ID/Investigator# 3932, Zaragoza

53154

Site Reference ID/Investigator# 4572, Oak Creek

53217

Site Reference ID/Investigator# 4545, Glendale

60590

Site Reference ID/Investigator# 3965, Frankfurt

60596

Site Reference ID/Investigator# 3927, Frankfurt am Main

60612

Site Reference ID/Investigator# 4548, Chicago

62704

Site Reference ID/Investigator# 4557, Springfield

65691

Site Reference ID/Investigator# 3968, Brno

67098

Site Reference ID/Investigator# 3918, Strasbourg

67203

Site Reference ID/Investigator# 4605, Wichita

72037

Site Reference ID/Investigator# 3979, Le Mans

72200

Site Reference ID/Investigator# 5559, Ostrava

75185

Site Reference ID/Investigator# 4017, Uppsala

75231

Site Reference ID/Investigator# 4536, Dallas

75679

Site Reference ID/Investigator# 3983, Paris

75701

Site Reference ID/Investigator# 6381, Tyler

77074

Site Reference ID/Investigator# 4538, Houston

78217

Site Reference ID/Investigator# 6899, San Antonio

79106

Site Reference ID/Investigator# 3925, Freiburg im Breisgau

80054

Site Reference ID/Investigator# 3982, Amiens

80230

Site Reference ID/Investigator# 4559, Denver

80336

Site Reference ID/Investigator# 3923, Munich

83642

Site Reference ID/Investigator# 10745, Meridian

85168

Site Reference ID/Investigator# 3963, Bydgoszcz

87102

Site Reference ID/Investigator# 4544, Albuquerque

90404

Site Reference ID/Investigator# 4571, Santa Monica

90505

Site Reference ID/Investigator# 9271, Torrance

92112

Site Reference ID/Investigator# 3959, Piešťany

Site Reference ID/Investigator# 3960, Piešťany

92260

Site Reference ID/Investigator# 4535, Palm Desert

92395

Site Reference ID/Investigator# 10746, Victorville

92543

Site Reference ID/Investigator# 9323, Hemet

97701

Site Reference ID/Investigator# 6227, Bend

98133

Site Reference ID/Investigator# 10744, Seattle

35294-7201

Site Reference ID/Investigator# 4547, Birmingham

92037-0943

Site Reference ID/Investigator# 4568, La Jolla

02720

Site Reference ID/Investigator# 6417, Fall River

03820

Site Reference ID/Investigator# 4561, Dover

07728

Site Reference ID/Investigator# 11222, Freehold

07055

Site Reference ID/Investigator# 6228, Passaic

19611-1124

Site Reference ID/Investigator# 4564, West Reading

1426AAL

Site Reference ID/Investigator# 3886, Buenos Aires

C1015ABO

Site Reference ID/Investigator# 3888, Buenos Aires

C1055AAF

Site Reference ID/Investigator# 6346, Buenos Aires

Unknown

Site Reference ID/Investigator# 3887, Quilmes

Site Reference ID/Investigator# 8485, Auckland

Site Reference ID/Investigator# 8488, Hamilton

Site Reference ID/Investigator# 8496, Timaru

Site Reference ID/Investigator# 8511, Wellington

T4000AXL

Site Reference ID/Investigator# 3889, San Miguel de Tucumán

A-8020

Site Reference ID/Investigator# 3911, Graz

L7R 1E2

Site Reference ID/Investigator# 6701, Burlington

T5M 0H4

Site Reference ID/Investigator# 6834, Edmonton

B3H 4K4

Site Reference ID/Investigator# 7197, Halifax

L8N 1Y2

Site Reference ID/Investigator# 3883, Hamilton

L8N 2B6

Site Reference ID/Investigator# 3884, Hamilton

H2L 1S6

Site Reference ID/Investigator# 3907, Montreal

H3Z 2Z3

Site Reference ID/Investigator# 3903, Montreal

K2G 6E2

Site Reference ID/Investigator# 5178, Ottawa

V7C 5L9

Site Reference ID/Investigator# 3904, Richmond

G1W 4R4

Site Reference ID/Investigator# 3912, Sainte-Foy, Quebec

N7T 5W6

Site Reference ID/Investigator# 3901, Sarnia

A1A 5E8

Site Reference ID/Investigator# 3906, St. John's

M9B 1B1

Site Reference ID/Investigator# 6542, Toronto

V8V 3P9

Site Reference ID/Investigator# 3882, Victoria

N8X 5A6

Site Reference ID/Investigator# 5616, Windsor

R3A 1M3

Site Reference ID/Investigator# 5847, Winnipeg

R3A 1M4

Site Reference ID/Investigator# 3905, Winnipeg

500 05

Site Reference ID/Investigator# 3971, Hradec Králové

128 50

Site Reference ID/Investigator# 3969, Prague

686 01

Site Reference ID/Investigator# 5548, Uherské Hradiště

D-61231

Site Reference ID/Investigator# 3926, Bad Nauheim

06120

Site Reference ID/Investigator# 4291, Halle

D-65719

Site Reference ID/Investigator# 8489, Hofheim

D-49074

Site Reference ID/Investigator# 8483, Osnabrück

CP 1300

Site Reference ID/Investigator# 3823, Mexico City

CP 14050

Site Reference ID/Investigator# 3891, Mexico City

6815 AD

Site Reference ID/Investigator# 3947, Arnhem

1213XZ

Site Reference ID/Investigator# 3948, Hilversum

N-6026

Site Reference ID/Investigator# 7607, Ålesund

N-2609

Site Reference ID/Investigator# 7511, Lillehammer

N-7006

Site Reference ID/Investigator# 7500, Trondheim

53-342

Site Reference ID/Investigator# 3961, Wroclaw

00725

Site Reference ID/Investigator# 3944, Caguas

00716

Site Reference ID/Investigator# 3937, Ponce

00918

Site Reference ID/Investigator# 3934, San Juan

00936-5067

Site Reference ID/Investigator# 3935, San Juan

0028

Site Reference ID/Investigator# 7172, Pretoria

03203

Site Reference ID/Investigator# 3930, Elche (Alicante)

SE-631 88

Site Reference ID/Investigator# 4015, Eskilstuna

SE-79182

Site Reference ID/Investigator# 3984, Falun

171 76

Site Reference ID/Investigator# 4014, Stockholm

BA1 1RL

Site Reference ID/Investigator# 4012, Bath

HD3 3EA

Site Reference ID/Investigator# 8495, Huddersfield

LS7 4SA

Site Reference ID/Investigator# 4048, Leeds

SE1 9RT

Site Reference ID/Investigator# 4013, London

NE7 7DN

Site Reference ID/Investigator# 4046, Newcastle upon Tyne

OX3 7LD

Site Reference ID/Investigator# 4047, Oxford

S016 6YD

Site Reference ID/Investigator# 3985, Southampton

YO31 8HE

Site Reference ID/Investigator# 7977, York

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Abbott

INDUSTRY