BI 695501 Compared to Adalimumab in Patients With Active Rheumatoid Arthritis

PHASE3CompletedINTERVENTIONAL
Enrollment

645

Participants

Timeline

Start Date

January 26, 2015

Primary Completion Date

March 3, 2016

Study Completion Date

October 18, 2016

Conditions
Arthritis, Rheumatoid
Interventions
DRUG

BI 695501

BI 695501, every two weeks for 48 weeks (25 injections in total)

DRUG

US-licensed Humira®

one injection every 2 weeks for 48 weeks (25 injections in total)

Trial Locations (138)

1336

MHAT Lyulin, Sofia

1504

DCC 17 - Sofia EOOD, Sofia

1601

Oleksandrivska Clinical Hospital, Kyiv

1606

MMA HAT Sofia, Bulgaria, Sofia

1612

UMHAT Sv. Ivan Rilski EAD, Sofia

4000

MHAT "Trimontium", OOD, Plovdiv, Plovdiv

4002

MHAT "Eurohospital" - Plovdiv, OOD, Plovdiv

MHAT - Kaspela, EOOD, Plovdiv

5000

MDHAT 'Dr. Stefan Cherkezov', AD, Veliko Tarnovo

6725

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klin. Kozpont, Szeged

7000

Medical Center "Teodora", EOOD, Ruse, Rousse

7002

MHAT,Fourth Dept. of Therapeutics & Cardiology, Ruse, Rousse

8022

CGM Research Trust, The Princess Margaret Hospital Cantebury, Cantebury

8200

Csolnoky Ferenc Korhaz, Veszprem, Veszprém

9000

DCC 'Chaika', EOOD, Varna, Varna

9700

MHAT Shumen AD, Shumen, Shumen

10400

Pramongkutklao Hospital, Rajathevee

10700

Siriraj Hospital, Bangkoknoi

10990

Hospital Pulau Pinang, Pulau Pinang

11000

Institute of Rheumatology, Belgrade, Belgrade

11030

Anna Imperato, MD PLLC, Manhasset

15000

General Hospital "Dr Laza K. Lazarevic" Sabac, Sabac, Šabac

15006

Hospital A Coruña, A Coruña

15705

Hosp. Nuestra Señora de la Esperanza, Santiago de Compostela, Santiago de Compostela

15706

Hospital Clínico de Santiago, Santiago de Compostela

16635

Altoona Center for Clinical Research, P.C., Duncansville

18205

Institute for Treatment and Rehabilitation, Niska Banja, Niška Banja

18209

Rheumazentrum Prof. Dr. G. Neeck, Bad Doberan, Bad Doberan

21018

M.I. Pyrogov VRCH, Vinnytsia, Vinnytsia

21029

MCIC MC LLC Health Clinic, Vinnytsia, Vinnytsia

21502

Klein and Associates, M.D., P.A., Cumberland

24541

Danville Orthopedic Clinic, Incorporated, Danville

25100

Hospital Tengku Ampuan Afzan, Kuantan

27157

Wake Forest University School of Medicine, Winston-Salem

27408

Medication Management, LLC, Greensboro

28040

Fundación Jiménez Díaz, Madrid

28144

PMG Research of Salisbury, LLC, Salisbury

28210

Box Arthritis & Rheumatology of the Carolinas, Charlotte

29651

Mountain View Clinical Research, Greer

33015

San Marcus Research Clinic, Inc., Miami

33026

Family Clinical Trials, Incorporated, Pembroke Pines

33134

Universal Clinical Research, Coral Gables

33143

Physician Research Collaboration, South Miami

33144

L&C Professional Medical Research Institute, Miami

33321

West Broward Rheumatology Associates, Incorporated, Tamarac

33437

Orthopedic Research Institute, Boynton Beach

33458

Science and Research Institute, Inc., Jupiter

33603

Clinical Research of West Florida, Inc., Tampa

33613

McIlwain Medical Group, PA, Tampa

33765

Clinical Research of West Florida, Inc., Clearwater

34292

Lovelace Scientific Resources, Incorporated, Venice

35205

Rheumatology Associates, Birmingham

35216

Achieve Clinical Research, LLC, Birmingham

36011

M.V. Sklifosovskyi Poltava RCH, Poltava, Poltava

36207

Pinnacle Research Group, LLC, Anniston

38801

North MS Medical Clinics, Incorporated, Tupelo

39112

SMO.MD GmbH, Magdeburg, Magdeburg

43551

Clinical Research Source, Inc., Perrysburg

45417

STAT Research, Incorporated, Dayton

46260

Goldpoint Clinical Research, LLC, Indianapolis

48202

Henry Ford Health System, Detroit

48903

Hospital Universitario de Cruces, Barakaldo

49503

Arthritis Education and Treatment Center, Grand Rapids

50107

Medita Kliinik OÜ, Tartu, Tartu

55543

ACURA Kliniken Rheinland-Pfalz AG, Bad Kreuznach, Bad Kreuznach

59901

Glacier View Research Institute, Kalispell

61039

L.T. Malaya Institute of Therapy AMS of Ukraine, Kharkiv

61176

CI of Healthcare Kharkiv CCH #8, Kharkiv, Kharkiv

61231

Kerckhoff-Klinik, Bad Nauheim, Bad Nauheim

67207

Heartland Research Associates, LLC, Wichita

68516

Accurate Clinical Research, Inc., Lincoln

69600

Zaporizhzhia Regional Clinical Hospital, Zaporizhzhia, Zaporizhzhia

71203

The Arthritis & Diabetes Clinic, Incorporated, Monroe

75231

Metroplex Clinical Research Center, Dallas

76018

Ivano-Frankivsk Nat. Medical University, Dept. Endocrinology, Ivano-Frankivsk

77004

Accurate Clinical Management LLC, Houston

77008

Pioneer Research Solutions, Inc., Houston

77034

Accurate Clinical Research, Incorporated, Houston

77058

Accurate Clinical Research, Incorporated, Nassau Bay

77070

Rheumatology Clinic Of Houston, P.A., Houston

77084

Accurate Clinical Research, Incorporated, Houston

77089

Houston Rheumatology Consultants, PLLC, Houston

78229

Heartland Research Associates, LLC, San Antonio

78404

Adriana Pop Moody Clinic PA, Corpus Christi

78731

Austin Regional Clinic, Austin

79424

Arthritis & Osteoporosis Associates LLP, Lubbock

80010

Pärnu Hospital, Pärnu, Pärnu

80304

Alpine Clinical Research Center, Boulder

83404

Institute of Arthritis Research, Idaho Falls

85037

Arizona Arthritis and Rheumatology Research, PLLC, Phoenix

85202

Arizona Arthritis and Rheumatology Research, PLLC, Mesa

85304

Arizona Arthritis and Rheumatology Research, PLLC, Glendale

87102

Albuquerque Center For Rheumatology, Albuquerque

90110

Songklanagarind Hospital, Hat Yai

90606

Medvin Clinical Research, Whittier

90623

Advanced Medical Research, LLC, La Palma

90808

ProHealth Partners, Long Beach

91786

Inland Rheumatology Clinical Trials, Inc., Upland

95051

The Permanente Medical Group, Santa Clara

99204

Arthritis Northwest, PLLC, Spokane

110744

Seoul National University Hospital, Seoul

115404

Practicheskaya Meditsina Ltd, Moscow

150003

Emergency Clinical Hospital n. a. N. V. Soloviev, Yaroslavl, Yaroslavl

150051

SBHI of Yaroslavl Area "Clinical Hospital #3", Yaroslavl

185019

Republic Kareliya Republican Hosp. named after V.A. Baranov, Petrozavodsk

355017

Stavropol State Medical Academy, Stavropol

410002

Reg. Hospital for war veterans, Saratov

443095

Samara Regional Clinical Hospital n.a MI Kalinin, Samara, Samara

650000

Kemerovo SMA b/o War Veterans Regional Clinical Hospital, Kemerovo

2570017

CINVEC - Centro de Investigacion Clinica V Reg.,Vina del Mar, Viña del Mar

5290000

Corporacion de Beneficencia Osorno, Osorno

5550170

Quantum Research Santiago, Puerto Varas, Puerto Varas

7500710

BIOMEDICA, Santiago, Santiago

7501126

Centro de Estudios Reumatológicos, Santiago

7510047

Centro Medico Prosalud, Santiago

85032-9384

Arizona Arthritis and Rheumatology Research, PLLC, Phoenix

92020-4124

TriWest Research Associates, LLC, El Cajon

01605

Clinical Pharmacology Study Group, Worcester

07012

NJP Clinical Research, Clifton

37203-2032

Center for Inflammatory Disease, Nashville

15-099

Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk, Bialystok

85-168

Szpital Uniwersytecki nr 2 im.dr J. Biziela, Bydgoszcz

82-300

Wojewodzki Szpital Zespolony w Elblagu, Elblag

81-338

Medica Pro Familia Spolka Akcyjna, Oddzial w Gdyni, Gdynia

05-825

MCBK Iwona Czajkowska Anna Podrazka- Szczepaniak S.C., Grodzisk Mazowiecki

40-954

Medical Centre Pratia Katowice I, Katowice

30-002

Medical Centre Pratia Krakow, Krakow

31-023

Specialist Center ALL-MED, Krakow, Krakow

87-100

Niepubliczny ZOZ, "Nasz Lekarz", Lekarzy Rodzinnych z, Torun

01-868

Medical Centre Pratia Warszawa, Warsaw

02-653

Reumatika, Rheumatology Center, non-public outpatient clinic, Warsaw

52-224

Wojewodzki Szpital Specjalistyczny we Wroclawiu, Wroclaw

21 000

Clinical Center of Vojvodina, Novi Sad

705-718

Daegu Catholic University Medical Center, Daegu

301-721

Chungnam National University Hospital, Daejeon

143-729

Konkuk University Medical Center, Seoul

03680

SI NSC M.D. Strazhesko Institute Cardiology of NAMSU, Kyiv, Kyiv

04114

SI D.F.Chebotariov Institute of Gerontology of NAMSU, Kyiv, Kyiv

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY