Methotrexate-Inadequate Response Study

PHASE3CompletedINTERVENTIONAL
Enrollment

2,492

Participants

Timeline

Start Date

January 31, 2008

Primary Completion Date

November 30, 2009

Study Completion Date

September 30, 2014

Conditions
Rheumatoid Arthritis (RA)
Interventions
DRUG

Subcutaneous (SC) Abatacept

Participants received 125 mg weekly SC abatacept injections (with an intravenous \[IV\] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment.

DRUG

Intravenous (IV) Abatacept

"Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo).~500mg (for body weight up to 60 kg)~750 mg (body weight between 61 and 100 kg)~1g (body weight above 100 kg)infusions"

Trial Locations (203)

0

Local Institution, Santiago

Local Institution, Guadalajara

4

Local Institution, Dublin

11

Local Institution, Lima

402

Local Institution, Taichung

404

Local Institution, Taichung

407

Local Institution, Taichung

833

Local Institution, Kaohsiung City

1015

Local Institution, Buenos Aires

1020

Local Institution, Brussels

1023

Local Institution, Budapest

1200

Local Institution, Brussels

1426

Local Institution, Buenos Aires

1619

Local Institution, Kempton Park

2000

Local Institution, Rosario, Santa Fe

2065

Local Institution, St Leonards

2610

Local Institution, Wilrijk

3000

Local Institution, Santa Fe

Local Institution, Leuven

3081

Local Institution, Heidelberg

3500

Local Institution, Hasselt

4000

Local Institution, San Miguel de Tucumán

4001

Local Institution, Durban

4012

Local Institution, Debrecen

4558

Local Institution, Maroochydore

5000

Local Institution, Córdoba

5011

Local Institution, Woodville

5016

Local Institution, Córdoba

5530

Local Institution, Yvoir

6008

Local Institution, Shenton Park

7500

Local Institution, Panorama

12206

The Center For Rheumatology, Llp, Albany

13008

Local Institution, Marseille

13059

Local Institution, Campinas

13083

Local Institution, Campinas

13210

Arthritis Health Associates, Syracuse

14059

Local Institution, Berlin

14760

Southern Tier Arthritis & Rheumatism, Olean

18015

East Penn Rheumatology Associates, Bethlehem

20070

Local Institution, Denizli

20230

Local Institution, Aguascalientes

20551

Local Institution, Rio de Janeiro

21502

Klein And Associates, M.D., Pa, Cumberland

22030

Local Institution, Edirne

22205

Arthritis Clinic Of Northern Virginia, P.C., Arlington

22320

Local Institution, Tijuana

23320

Center For Arthritis & Rheumatic Diseases, Pc, Chesapeake

27100

Local Institution, Pavia

27310

Local Institution, Gaziantep

27704

Rheumatology, Durham

27834

Physicians East, Pa, Greenville

28210

The Arthritis Clinic & Carolina Bone & Joint, Charlotte

28401

Carolina Arthritis Associates, Wilmington

28625

Carolina Pharmaceutical Research, Statesville

28801

Asheville Rheumatology & Osteoporosis Research Asso P. A., Asheville

29118

Acme Research, Llc, Orangeburg

29204

Columbia Arthritis Center, Columbia

29406

Low Country Rheumatology, Pa, Charleston

29572

Carolina Health Specialists, Myrtle Beach

29609

Local Institution, Brest

30342

Arthritis & Rheumatology Of Georgia,Pc, Atlanta

31000

Local Institution, Chihuahua City

32073

Arthritis & Osteoporosis Treatment Center, Pa, Orange Park

32806

Rheumatology Associates Of Central Florida, Orlando

33076

Local Institution, Bordeaux

33180

Arthritis And Rheumatic Disease Specialties, Aventura

34239

Sarasota Arthritis Research Center, Sarasota

34684

The Arthritis Center, Palm Harbor

35128

Local Institution, Padua

35205

Rheumatology Associates, Pc, Birmingham

36010

Local Institution, Juiz de Fora

36608

Coastal Clinical Research, Inc, Mobile

37170

Local Institution, Chambray-lès-Tours

37205

St. Thomas Hospital Tower East, Nashville

37909

Rheumatology Consultants Pllc, Knoxville

38104

The Arthritis Group, Pc, Memphis

38305

Arthritis Clinic, Jackson

39202

Arthritis Assoicates Of Mississippi, Jackson

44100

Local Institution, Guadalajara

44620

Local Institution, Guadalajara

44690

Local Institution, Guadalajara

45219

Cincinnati Rheumatic Disease Study Group, Cincinnati

48081

Shores Rheumatology, P. C., Saint Clair Shores

50670

Local Institution, Recife

53100

Local Institution, Siena

58270

Local Institution, Morelia

59037

Local Institution, Lille

60773

Local Institution, Poznan

61107

Rockford Orthopedic Associates, Ltd., Rockford

62301

Quincy Medical Group, Quincy

62704

The Arthritis Center, Springfield

64020

Local Institution, Nuevo León

64086

Kansas City Internal Medicine, Lee's Summit

67098

Local Institution, Strasbourg

68516

Physician Research Collaboration, Llc, Lincoln

71110

Local Institution, Heraklion Crete

71913

St. Joseph'S Mercy Clinic, Hot Springs

72037

Local Institution, Le Mans

73103

Health Research Of Oklahoma, Oklahoma City

74104

Oklahoma Center For Arthritis Therapy And Research, Tulsa

74110

Local Institution, Goiânia

74135

Healthcare Research Consultants, Tulsa

74605

Local Institution, Goiânia

75651

Local Institution, Paris

75679

Local Institution, Paris

76178

Local Institution, Querétaro City

77004

Rheumatic Disease Clinical Research Center, Llc, Houston

77034

Accurate Clinical Research, Houston

77479

Texas Research Center, Sugarland

78240

Local Institution, San Luis Potosí City

78705

Walter F. Chase, Austin

80131

Local Institution, Napoli

80230

Denver Arthritis Clinic, Denver

80304

Boulder Medical Center, Boulder

80440

Local Institution, Curitiba

80538

Arthritis Center Of The Rockies, Pc, Loveland

80639

Local Institution, München

80910

Arthritis Assoc And Osteo Ctr Of Col Sprgs, Colorado Springs

81541

Local Institution, München

83702

Boise Rheumatology/ Intermountain Research Center, Inc, Boise

83814

Coeur D'Alene Arthrit Clin, Coeur d'Alene

85258

Advanced Arthritis Care & Research, Scottsdale

85704

Catalina Pointe Clinical Research, Inc., Tucson

86021

Local Institution, Poitiers

87102

Albuquerque Clinical Trials, Inc., Albuquerque

Albuquerque Rehabilitation & Rheumatology Pc, Albuquerque

90806

Valerius Medical Group &Research Ctr. Of Greater Long Beach, Long Beach

91610

Local Institution, Porto Alegre

92037

Allergy & Rheumatology Medical Clinic, Inc., La Jolla

92108

San Diego Arthritis Medical Clinic, San Diego

92646

Talbert Medical Group, Huntington Beach

94304

Stanford University School Of Medicine, Palo Alto

97000

Local Institution, Mérida

97035

Portland Rheumatology Clinic, Llc, Lake Oswego

97401

Pro Research, Eugene

98405

Tacoma Center For Arthritis Research Ps, Tacoma

98502

South Puget Sound Clinincal Research Center, Olympia

110029

Local Institution, New Delhi

115522

Local Institution, Moscow

119049

Local Institution, Moscow

129327

Local Institution, Moscow

150003

Local Institution, Yaroslavl

226014

Local Institution, Lucknow

380009

Local Institution, Navrangpura, Ahmedabad

500003

Local Institution, Secunderabad

500004

Local Institution, Hyderabad

560003

Local Institution, Bangalore

620102

Local Institution, Yekaterinburg

7500995

Local Institution, Santiago

80060240

Local Institution, Curitiba

90035003

Local Institution, Porto Alegre

06606

Guadagnoli, Germano, Bridgeport

Joao Nascimento, Bridgeport

06810

Clinical Research Center Of Ct/Ny, Danbury

01610

Clinical Pharmacology Study Group, Worcester

07801

Allergy And Arthritis Associates, Dover

02906

Rheumatology Associates, Providence

C1428DQG

Local Institution, Buenos Aires

CP1425A WC

Local Institution, Ciudad Autonoma

QLD 4870

Local Institution, Cairns

04027

Local Institution, São Paulo

R3A 1M3

Local Institution, Winnipeg

A1A 5E8

Local Institution, St. John's

L8N 1Y2

Local Institution, Hamilton

L8N 2B6

Local Institution, Hamilton

L5M 2V8

Local Institution, Mississauga

K1H 1A2

Local Institution, Ottawa

G1V 3M7

Local Institution, Ste-Foy

G1W 4R4

Local Institution, Ste-Foy

G8Z 1Y2

Local Institution, Trois-Rivières

S7N 0W8

Local Institution, Saskatoon

Unknown

Local Institution, Santiago

06202

Local Institution, Nice

04103

Local Institution, Leipzig

560 034

Local Institution, Bangalore

00168

Local Institution, Roma

06726

Local Institution, Mexico City

8934 AD

Local Institution, Leeuwarden

LIMA 13

Local Institution, Lima

LIMA 27

Local Institution, Lima

LIMA 33

Local Institution, Lima

CALLAO 2

Local Institution, Callao

15-337

Local Institution, Bialystok

15-461

Local Institution, Bialystok

85-168

Local Institution, Bydgoszcz

26-200

Local Institution, Gmina Końskie

30-510

Local Institution, Krakow

60-218

Local Institution, Poznan

87-100

Local Institution, Torun

02-777

Local Institution, Warsaw

0002

Local Institution, Muckleneuk

0132

Local Institution, Muckleneuk

0083

Local Institution, Pretoria

133-792

Local Institution, Seoul

705-718

Local Institution, Daegu

302-799

Local Institution, Daejeon

135-710

Local Institution, Seoul

137-040

Local Institution, Seoul

CB2 2QQ

Local Institution, Cambridge

CF31 1RQ

Local Institution, Bridgend

E11 1NR

Local Institution, London

SO16 6YD

Local Institution, Southampton

NE7 7DN

Local Institution, Newcastle upon Tyne

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY

NCT00559585 - Methotrexate-Inadequate Response Study | Biotech Hunter | Biotech Hunter