Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.

PHASE3CompletedINTERVENTIONAL
Enrollment

619

Participants

Timeline

Start Date

February 29, 2000

Primary Completion Date

September 30, 2002

Study Completion Date

August 31, 2010

Conditions
Rheumatoid Arthritis
Interventions
BIOLOGICAL

Adalimumab

Self-administered, subcutaneous injection of 20 mg adalimumab (1.6 mL/injection) once weekly (ew) for up to 52 weeks.

BIOLOGICAL

Adalimumab

Self-administered, subcutaneous injection of 40 mg adalimumab (1.6 mL/injection) every other week (eow) for up to 52 weeks.

DRUG

Placebo

Self-administered, subcutaneous injection of placebo (1.6 mL/injection) once weekly (ew) for up to 52 weeks.

BIOLOGICAL

Adalimumab

Self-administration, subcutaneous (SC) injection of adalimumab 20 mg (1.6 mL/injection) once weekly (ew) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL/injection) every other week (eow) for up to Week 520.

BIOLOGICAL

Adalimumab

Self-administration, subcutaneous (SC) injection of adalimumab 40 mg (1.6 mL/injection) every other week (eow) (with a placebo 1.6 mL/injection on alternate weeks) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL injection) eow for up to Week 520.

BIOLOGICAL

Adalimumab

Self-administration, subcutaneous (SC) injection of placebo solution (1.6 mL/injection) once weekly (ew) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL/injection) every other week (eow) for up to Week 520.

Trial Locations (87)

14609

Site Ref # / Investigator 483, Rochester

15090

Site Ref # / Investigator 480, Wexford

16635

Site Ref # / Investigator 2507, Duncansville

17055

Site Ref # / Investigator 352, Mechanicsburg

19401

Site Ref # / Investigator 717, East Norriton

19610

Site Ref # / Investigator 2511, Wyomissing

Site Ref # / Investigator 60724, Wyomissing

20902

Site Ref # / Investigator 730, Wheaton

21239

Site Ref # / Investigator 392, Baltimore

21502

Site Ref # / Investigator 354, Cumberland

22044

Site Ref # / Investigator 60725, Falls Church

23219

Site Ref # / Investigator 711, Richmond

27408

Site Ref # / Investigator 340, Greensboro

27609

Site Ref # / Investigator 461, Raleigh

Site Ref # / Investigator 500, Raleigh

27612

Site Ref # / Investigator 60731, Raleigh

27704

Site Ref # / Investigator 512, Durham

28144

Site Ref # / Investigator 60737, Salisbury

29406

Site Ref # / Investigator 718, Charleston

32806

Site Ref # / Investigator 499, Orlando

33180

Site Ref # / Investigator 710, Aventura

33542

Site Ref # / Investigator 463, Zephyrhills

33614

Site Ref # / Investigator 729, Tampa

34698

Site Ref # / Investigator 498, Dunedin

35801

Site Ref # / Investigator 424, Huntsville

36608

Site Ref # / Investigator 2510, Mobile

37205

Site Ref # / Investigator 462, Nashville

38119

Site Ref # / Investigator 460, Memphis

40509

Site Ref # / Investigator 491, Lexington

44143

Site Ref # / Investigator 456, Mayfield Village

46260

Site Ref # / Investigator 2506, Indianapolis

46601

Site Ref # / Investigator 732, South Bend

49009

Site Ref # / Investigator 473, Kalamazoo

49506

Site Ref # / Investigator 471, Grand Rapids

53142

Site Ref # / Investigator 60738, Kenosha

60611

Site Ref # / Investigator 60732, Chicago

62704

Site Ref # / Investigator 726, Springfield

63110

Site Ref # / Investigator 502, St Louis

63128

Site Ref # / Investigator 482, St Louis

63141

Site Ref # / Investigator 371, St Louis

64114

Site Ref # / Investigator 731, Kansas City

66216

Site Ref # / Investigator 60730, Shawnee Mission

67203

Site Ref # / Investigator 467, Wichita

67208

Site Ref # / Investigator 494, Wichita

68114

Site Ref # / Investigator 487, Omaha

73112

Site Ref # / Investigator 470, Oklahoma City

Site Ref # / Investigator 60723, Oklahoma City

77074

Site Ref # / Investigator 2509, Houston

Site Ref # / Investigator 510, Houston

78705

Site Ref # / Investigator 716, Austin

83404

Site Ref # / Investigator 485, Idaho Falls

83704

Site Ref # / Investigator 2436, Boise

85012

Site Ref # / Investigator 60729, Phoenix

85260

Site Ref # / Investigator 725, Scottsdale

91405

Site Ref # / Investigator 60739, Van Nuys

92025

Site Ref # / Investigator 360, Escondido

92037

Site Ref # / Investigator 469, La Jolla

92260

Site Ref # / Investigator 419, Palm Desert

92801

Site Ref # / Investigator 60736, Anaheim

93405

Site Ref # / Investigator 60734, San Louis Obispo

95126

Site Ref # / Investigator 492, San Jose

97401

Site Ref # / Investigator 422, Eugene

98405

Site Ref # / Investigator 464, Tacoma

99204

Site Ref # / Investigator 356, Spokane

92037-0943

Site Ref # / Investigator 714, La Jolla

06810

Site Ref # / Investigator 712, Danbury

04102

Site Ref # / Investigator 2508, Portland

01805

Site Ref # / Investigator 465, Burlington

01610

Site Ref # / Investigator 2512, Worcester

03301

Site Ref # / Investigator 353, Concord

03820

Site Ref # / Investigator 364, Dover

08619

Site Ref # / Investigator 60726, Mercerville

08043

Site Ref # / Investigator 358, Voorhees Township

18915-9671

Site Ref # / Investigator 60735, Colmar

77555-0759

Site Ref # / Investigator 60728, Galveston

98166-2967

Site Ref # / Investigator 509, Seattle

T2N 4N1

Site Ref # / Investigator 475, Calgary

V2A 3G8

Site Ref # / Investigator 495, Penticton

V7C 5L9

Site Ref # / Investigator 2496, Richmond

R3N OK6

Site Ref # / Investigator 2495, Winnipeg

B3H 4K4

Site Ref # / Investigator 496, Halifax

L3Y 3R7

Site Ref # / Investigator 444, Newmarket

M4N 3M5

Site Ref # / Investigator 2497, Toronto

M5L 3L9

Site Ref # / Investigator 478, Toronto

M5T 2S8

Site Ref # / Investigator 421, Toronto

H3Z 2Z3

Site Ref # / Investigator 363, Montreal

S7N 0W8

Site Ref # / Investigator 60702, Saskatoon

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Abbott

INDUSTRY