Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis

PHASE3CompletedINTERVENTIONAL
Enrollment

799

Participants

Timeline

Start Date

December 31, 2000

Primary Completion Date

April 30, 2004

Study Completion Date

April 30, 2012

Conditions
Early Rheumatoid Arthritis
Interventions
BIOLOGICAL

Adalimumab

DRUG

Methotrexate

BIOLOGICAL

Adalimumab placebo

DRUG

Methotrexate placebo

Trial Locations (123)

1011

Site Reference ID/Investigator# 334, Lausanne

1070

Site Reference ID/Investigator# 753, Brussels

1090

Site Reference ID/Investigator# 344, Vienna

Site Reference ID/Investigator# 308, Brussels

1200

Site Reference ID/Investigator# 752, Brussels

2010

Site Reference ID/Investigator# 331, Darlinghurst, Sydney

2050

Site Reference ID/Investigator# 755, Camperdown

2217

Site Reference ID/Investigator# 745, Kogarah

2305

Site Reference ID/Investigator# 335, New Lambton

3000

Site Ref # / Investigator 98256, Leuven

3081

Site Reference ID/Investigator# 427, West Heidelberg

3168

Site Reference ID/Investigator# 337, Clayton

3590

Site Reference ID/Investigator# 748, Diepenbeek

4000

Site Reference ID/Investigator# 333, Liège

4102

Site Reference ID/Investigator# 310, Brisbane

4558

Site Reference ID/Investigator# 738, Maroochydore

5011

Site Reference ID/Investigator# 739, Woodville

6008

Site Reference ID/Investigator# 737, Shenton Park

6300

Site Ref # / Investigator 95878, Gråsten

7004

Site Reference ID/Investigator# 307, South Hobart

9000

Site Reference ID/Investigator# 6136, Ghent

10117

Site Reference ID/Investigator# 4631, Berlin

13125

Site Reference ID/Investigator# 3417, Buch

14059

Site Reference ID/Investigator# 759, Berlin

15706

Site Reference ID/Investigator# 390, Santiago de Compostela

16132

Site Ref # / Investigator 95719, Genoa

16635

Site Reference ID/Investigator# 4649, Duncansville

18015

Site Reference ID/Investigator# 316, Bethlehem

19002

Site Reference ID/Investigator# 750, Guadalajara

20902

Site Reference ID/Investigator# 326, Wheaton

21502

Site Reference ID/Investigator# 319, Cumberland

21740

Site Ref # / Investigator 95960, Hagerstown

27704

Site Reference ID/Investigator# 488, Durham

28040

Site Reference ID/Investigator# 1526, Madrid

Site Reference ID/Investigator# 741, Madrid

33100

Site Reference ID/Investigator# 345, Udine

33180

Site Reference ID/Investigator# 762, Aventura

33542

Site Reference ID/Investigator# 325, Zephyrhills

33614

Site Reference ID/Investigator# 327, Tampa

34239

Site Reference ID/Investigator# 328, Sarasota

34295

Site Reference ID/Investigator# 348, Montpellier

35056

Site Reference ID/Investigator# 733, Rennes

37134

Site Reference ID/Investigator# 756, Verona

39245

Site Reference ID/Investigator# 338, Vogelsang-Gommern

40882

Site Reference ID/Investigator# 744, Ratingen

41014

Site Reference ID/Investigator# 749, Seville

45408

Site Reference ID/Investigator# 314, Dayton

61103

Site Reference ID/Investigator# 302, Rockford

67098

Site Reference ID/Investigator# 346, Strasbourg

68516

Site Reference ID/Investigator# 336, Lincoln

69310

Site Reference ID/Investigator# 3415, Pierre-Bénite

73103

Site Reference ID/Investigator# 761, Oklahoma City

75185

Site Reference ID/Investigator# 747, Uppsala

75231

Site Reference ID/Investigator# 2437, Dallas

75679

Site Reference ID/Investigator# 4650, Paris

77074

Site Reference ID/Investigator# 2532, Houston

Site Reference ID/Investigator# 758, Houston

78705

Site Ref # / Investigator 96122, Austin

Site Reference ID/Investigator# 306, Austin

Site Reference ID/Investigator# 313, Austin

79106

Site Reference ID/Investigator# 347, Freiburg im Breisgau

80131

Site Reference ID/Investigator# 323, Naples

80230

Site Reference ID/Investigator# 2500, Denver

80336

Site Ref # / Investigator 98125, Munich

Site Reference ID/Investigator# 339, Munich

85260

Site Reference ID/Investigator# 322, Scottsdale

90048

Site Reference ID/Investigator# 2491, Los Angeles

91054

Site Reference ID/Investigator# 4630, Erlangen

92037

Site Ref # / Investigator 95957, La Jolla

Site Reference ID/Investigator# 429, La Jolla

92112

Site Reference ID/Investigator# 3426, Piešťany

93009

Site Reference ID/Investigator# 428, Bobigny

97035

Site Reference ID/Investigator# 361, Lake Oswego

97401

Site Reference ID/Investigator# 757, Eugene

98902

Site Reference ID/Investigator# 305, Yakima

99204

Site Reference ID/Investigator# 321, Spokane

01605-0000

Site Reference ID/Investigator# 2533, Worcester

03301

Site Reference ID/Investigator# 318, Concord

M3H 5Y8

Site Ref # / Investigator 98199, North York

T6G 2S2

Site Reference ID/Investigator# 4646, Edmonton

L8N 1Y2

Site Reference ID/Investigator# 303, Hamilton

L8N 2B6

Site Reference ID/Investigator# 330, Hamilton

H2L 1S6

Site Reference ID/Investigator# 4634, Montreal

H3Z 2Z3

Site Reference ID/Investigator# 311, Montreal

L3Y 3R7

Site Reference ID/Investigator# 309, Newmarket

H9J 3W3

Site Reference ID/Investigator# 304, Pointe-Claire

V7C 5L9

Site Reference ID/Investigator# 4633, Richmond

A1A 5E8

Site Reference ID/Investigator# 763, St. John's

M4N 3M5

Site Reference ID/Investigator# 4635, Toronto

M5L 3L9

Site Reference ID/Investigator# 490, Toronto

V8V 3P9

Site Reference ID/Investigator# 760, Victoria

R3N OK6

Site Reference ID/Investigator# 4632, Winnipeg

500 05

Site Reference ID/Investigator# 754, Hradec Králové

305 99

Site Reference ID/Investigator# 332, Pilsen

128 50

Site Reference ID/Investigator# 734, Prague

FI-18120

Site Reference ID/Investigator# 6135, Heinola

00029

Site Ref # / Investigator 6134, Helsinki

02826

Site Reference ID/Investigator# 742, Görlitz

04103

Site Reference ID/Investigator# 746, Leipzig

WDQ-23-KM9

Site Reference ID/Investigator# 740, Cork

Unknown

Site Reference ID/Investigator# 751, Dublin

9713 GZ

Site Reference ID/Investigator# 343, Groningen

2333 ZA

Site Reference ID/Investigator# 6133, Leiden

6229 HX

Site Reference ID/Investigator# 317, Maastricht

6500 HB

Site Reference ID/Investigator# 315, Nijmegen

0027

Site Ref # / Investigator 95800, Oslo

0370

Site Ref # / Investigator 95875, Oslo

03010

Site Ref # / Investigator 96121, Alicante

Site Reference ID/Investigator# 735, Alicante

08036

Site Reference ID/Investigator# 1525, Barcelona

08915

Site Reference ID/Investigator# 1528, Barcelona

113 24

Site Reference ID/Investigator# 728, Stockholm

171 76

Site Reference ID/Investigator# 2565, Stockholm

SE-141 86

Site Reference ID/Investigator# 4638, Stockholm

901 84

Site Ref # / Investigator 96126, Umeå

S-721 89

Site Ref # / Investigator 96120, Västerås

Site Reference ID/Investigator# 736, Västerås

LL57 2PW

Site Ref # / Investigator 96116, Bangor

CB2 0QQ

Site Ref # / Investigator 95877, Cambridge

HR1 2ER

Site Ref # / Investigator 98258, Hereford

LS1 3EX

Site Ref # / Investigator 95795, Leeds

SE1 9RT

Site Ref # / Investigator 95958, London

NE7 7DN

Site Ref # / Investigator 98255, Newcastle upon Tyne

All Listed Sponsors
lead

AbbVie (prior sponsor, Abbott)

INDUSTRY

NCT00195663 - Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis | Biotech Hunter | Biotech Hunter