NCT01373151 - Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate | Biotech Hunter

Enrollment

418

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

September 30, 2012

Study Completion Date

June 30, 2015

Conditions

Rheumatoid Arthritis

Interventions

DRUG

BMS-945429 Placebo

Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only

BIOLOGICAL

BMS-945429

Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only

BIOLOGICAL

BMS-945429

Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks

BIOLOGICAL

BMS-945429

Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48

BIOLOGICAL

BMS-945429

Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks

DRUG

Methotrexate

Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only

DRUG

Methotrexate

Tablets, Oral, 15 mg, Weekly, 48 weeks

DRUG

Methotrexate Placebo

Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only

DRUG

Methotrexate

Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only

DRUG

Adalimumab Placebo

Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks

DRUG

Adalimumab

Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks

Trial Locations (100)

333

Local Institution, Taoyuan District

404

Local Institution, Taichung

500

Local Institution, Changhua

833

Local Institution, Kaohsiung City

1015

Local Institution, Capital Federal

1027

Local Institution, Budapest

1200

Local Institution, Brussels

1425

Local Institution, Capital Federal

1428

Local Institution, Capital Federal

1431

Local Institution, Capital Federal

2000

Local Institution, Rosario

3500

Local Institution, Hasselt

4000

Local Institution, San Miguel de Tucumán

4001

Local Institution, Durban

4012

Local Institution, Debrecen

5000

Local Institution, Córdoba

5400

Local Institution, San Juan

5700

Local Institution, Gyula

7405

Local Institution, Pinelands, Cape Town

7500

Local Institution, Panorama

7505

Local Institution, Tygerberg

8200

Local Institution, Veszprém

11850

Local Institution, Mexico City

14059

Local Institution, Berlin

15006

Local Institution, A Coruña

15706

Local Institution, Santiago de Compostela

16635

Altoona Center For Clinical Research, Duncansville

18015

East Penn Rheumatology Associates, P.C., Bethlehem

28040

Local Institution, Madrid

28210

Box Arthritis And Rheumatology Of The Carolinas, Pllc, Charlotte

33076

Local Institution, Bordeaux

35128

Local Institution, Padua

36010

Local Institution, Juiz de Fora

37170

Local Institution, Chambray-lès-Tours

39008

Local Institution, Santander

39202

Arthritis Associates Of Mississippi, Jackson

41071

Local Institution, Seville

42100

Local Institution, Reggio Emilia

42650

Local Institution, Guadalajara

45040

Local Institution, Guadalajara

50931

Local Institution, Cologne

58270

Local Institution, Morelia

60773

Local Institution, Poznan

61107

Rockford Orthopedic Associates, Llc., Rockford

62301

Quincy Medical Group, Quincy

64020

Local Institution, Monterrey

67098

Local Institution, Strasbourg

68516

Physician Research Collaboration, Llc, Lincoln

73103

Health Research Of Oklahoma, Oklahoma City

74110

Local Institution, Goiânia

78213

Local Institution, San Luis Potosí City

80060

Local Institution, Curitiba

80131

Local Institution, Napoli

80230

Local Institution, Culiacán

80440

Local Institution, Curitiba

85381

Sun Valley Arthritis Center, Ltd., Peoria

91610

Local Institution, Porto Alegre

92108

San Diego Arthritis Medical Clinic, San Diego

97080

Local Institution, Würzburg

98104

Seattle Rheumatology Associates, Seattle

115522

Local Institution, Moscow

150003

Local Institution, Yaroslavl

191014

Local Institution, Saint Petersburg

420064

Local Institution, Kazan'

620102

Local Institution, Yekaterinburg

630005

Local Institution, Novosibirsk

1138519

Local Institution, Bunkyo-ku

1608582

Local Institution, Shinjuku-Ku

1708476

Local Institution, Toshima-ku

2608712

Local Institution, Chiba

3808582

Local Institution, Nagano

4208623

Local Institution, Shizuoka

5458586

Local Institution, Osaka

6731462

Local Institution, Kato-shi

7390002

Local Institution, Higashi-hiroshima-shi

8078555

Local Institution, Kitakyushu-shi

8528501

Local Institution, Nagasaki

8571195

Local Institution, Sasebo-shi

8800122

Local Institution, Miyazaki

9010243

Local Institution, Tomigusuku-shi

06611

New England Research Associates, Llc, Trumbull

01605

Clinical Pharmacology Study Group, Worcester

04032

Local Institution, São Paulo

04266

Local Institution, São Paulo

H2L 1S6

Local Institution, Montreal

G1W 4R4

Local Institution, Québec

G8Z 1Y2

Centre De Recherche Musculo-Squelettique, Trois-Rivières

128 50

Local Institution, Prague

140 59

Local Institution, Prague

04103

Local Institution, Leipzig

1056 AB

Local Institution, Amsterdam

40-748

Local Institution, Katowice

31-531

Local Institution, Krakow

01-868

Local Institution, Warsaw

02-118

Local Institution, Warsaw

0083

Local Institution, Pretoria

0132

Local Institution, Pretoria

705-718

Local Institution, Daegu

133-792

Local Institution, Seoul

137-701

Local Institution, Seoul