Phase IIb Study of Evobrutinib in Subjects With Rheumatoid Arthritis

PHASE2CompletedINTERVENTIONAL
Enrollment

390

Participants

Timeline

Start Date

September 18, 2017

Primary Completion Date

September 23, 2019

Study Completion Date

September 23, 2019

Conditions
Rheumatoid Arthritis
Interventions
DRUG

M2591 25 mg QD

Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 12 weeks.

DRUG

M2951 75 mg QD

Participants received 75 mg of M2951 orally QD for 12 weeks.

DRUG

M2951 50 mg BID

Participants received 50 mg of M2951 orally twice daily (BID) for 12 weeks.

DRUG

Placebo

Participants received placebo matched to M2951 orally for 12 weeks.

Trial Locations (98)

1431

"DCC Alexandrovska, EOOD", Sofia

1619

Clinresco Centres (Pty) Ltd, Kempton Park

1797

"UMHAT SofiaMed, OOD", Sofia

2193

Wits Clinical Research, Johannesburg

4319

Naidoo, A, Durban

5400

Centro Polivalente de Asistencia e Inv. Clinica CER, San Juan

7405

Arthritis Clinical Research Trial Unit, Cape Town

7600

Winelands Medical Research Centre, Stellenbosch

8800

"MHAT Hadzhi Dimitar, OOD", Sliven

11000

Institute of Rheumatology_Site 1, Belgrade

Military Medical Academy, Belgrade

11080

Clinical Center Bezanijska kosa, Belgrade

15000

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

18205

"Institute of Treatment and Rehabilitation Niska Banja", Niška Banja

21018

National Pirogov Memorial Medical University, Vinnytsia

21200

Centro Investigacion en Artritis y Osteoporosis S.C., Mexicali

27410

Medication Management, LLC, Greensboro

31000

Investigacion y Biomedicina de Chihuahua, S.C., Chihuahua City

32713

Omega Research Consultants, DeBary

33603

Clinical Research of West Florida, Inc., Tampa

33614

McIlwain Medical Group, PA, Tampa

34270

Centro de Investigacion y Atencion Integral Durango CIAID, Durango

36011

M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA, Poltava

44650

Clinica de Investigacion en Reumatologia y Obesidad S.C., Guadalajara

61039

GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine, Kharkiv

61176

Communal Institution of Healthcare Kharkiv City Clinical Hospital #8, Kharkiv

69104

CI City Hospital #1, Zaporizhzhia

69600

CI Zaporizhzhia Regional Clinical Hospital of ZRC, Zaporizhzhia

CI Zaporizhzhia Regional Clinical Hospital of ZRC, Zaporizhzhya

76001

Clinica de Artritis Temprana S.A., Santiago de Cali

76008

Regional CH Dep of Rheumatology SHEI Ivano-Frankivsk NMU, Ivano-Frankivsk

78666

Arthritis Clinic Of Central Texas, San Marcos

79049

CH of State Border Service of Ukraine (Military Base 2522) Dept of Therapy, D.Halytskyi Lviv NMU, Lviv

85032

Arizona Arthritis & Rheumatology Associates, P.C., Phoenix

85037

Arizona Arthritis & Rheumatology Research, PLLC, Phoenix

88000

A.Novak Transcarpathian Regional Clinical Hospital, Uzhhorod

94578

East Bay Rheumatology Medical Group, Inc., San Leandro

110221

Riesgo de Fractura S.A., Bogotá

111211

Simedics Ips Sas, Bogotá

150003

"SAIH of Yaroslavl region Clinical Hospital of Emergency Medical Care n.a. N. V. Solovyev", Yaroslavl

"SBHI of Yaroslavl Region Clinical Hospital # 8", Yaroslavl

190068

"SPb SBIH Clinical Rheumatological Hospital # 25", Saint Petersburg

192242

Research Institute of Emergency Medical Care, Saint Petersburg

196066

LLC Medical Sanitary Unit#157, Saint Petersburg

214025

"NIH Departmental Hospital on Station Smolensk of OJSC Russian Railways", Smolensk

630091

"Limited Liability Company Centre of Medical Common Practice", Novosibirsk

644024

Ultramed, Omsk

680003

Servimed S.A.S., Bucaramanga

7500000

Centro Medico Prosalud, Santiago

7500010

Interin, Santiago

7500710

BioMedica Research Group, Santiago

7501126

Centro de Estudios Reumatologicos, Santiago

B1900AXI

Hospital Italiano de La Plata, La Plata

B7600FZ

Instituto de Investigaciones Clinicas, Mar del Plata

B1878DVB

Instituto Medico CER, Quilmes

B1878GEG

Instituto de Investigaciones Clinicas Quilmes, Quilmes

T4000AXL

Centro Medico Privado de Reumatologia, San Miguel de Tucumán

T4000BRD

Centro de Investigaciones Reumatológicas, San Miguel de Tucumán

C1015ABO

Organizacion Medica de Investigacion (OMI), Ciudad Autonoma Buenos Aires

C1046AAQ

APRILLUS, Ciudad Autonoma Buenos Aires

C1128AAE

Expertia S.A- Mautalen Salud e Investigación, Ciudad Autonoma Buenos Aires

C1221ADC

Hospital General de Agudos Dr. J. M. Ramos Mejia, Ciudad Autonoma Buenos Aires

X5000BNB

ILAIM-CEOM Inst. Latinoamericano de Inv. Medicas, Córdoba

X5000EDC

Instituto Reumatológico Strusberg, Córdoba

080001

Centro de Reumatologia y Ortopedia SAS, Barranquilla

Unknown

Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM, Bogotá

586 01

Revmatolog, s.r.o, Jihlava

702 00

CCBR Ostrava s.r.o., Ostrava

722 00

ARTROSCAN s.r.o., Ostrava - Trebovice

100 00

CLINTRIAL s.r.o., Prague

140 00

MUDR. Zuzana URBANOVA Revmatologie, Prague

MUDR. Zuzana URBANOVA Revmatologie, Praha 4 Nusle

140 59

Thomayerova nemocnice, Praha 4 - Krc

686 01

MEDICAL PLUS s.r.o., Uherské Hradiště

760 01

PV-MEDICAL s.r.o., Zlín

03100

RM Pharma Specialists SA de CV, Mexico City

15-879

ClinicMed Daniluk, Nowak Spółka Jawna, Bialystok

82-300

Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska lek. Barbara Bazela, Elblag

05-825

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

40-060

Care Clinic, Katowice

40-282

Silmedic sp. z o.o, Katowice

44-190

Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla, Knurów

30-510

Malopolskie Centrum Medyczne s.c., Krakow

31-024

"Grazyna Pulka Specjalistyczny Osrodek ALL-MED", Krakow

57-300

GLOBE CLINICAL RESEARCH (Globe Badania Kliniczne Sp z o.o.), Kłodzko

60-773

Centrum Badan Klinicznych S.C., Poznan

96-500

RCMed, Sochaczew

00-660

Medycyna Kliniczna, Warsaw

02-118

Rheuma Medicus Zaklad Opieki Zdrowotnej, Warsaw

03-291

Centrum Medyczne AMED, Warsaw

04-141

Wojskowy Instytut Medyczny, Warsaw

50-244

Reum-Medica S.C Eliza Roszkowska, Wroclaw

0002

Emmed Research, Pretoria

University of Pretoria Clinical Research Unit, Pretoria

01601

Medical Center Medical Clinic Blagomed LLC, Kyiv

02091

Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC, Kyiv

04070

Medical Center of Revmotsentr LLC, Kyiv

04114

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

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

EMD Serono Research & Development Institute, Inc.

INDUSTRY

NCT03233230 - Phase IIb Study of Evobrutinib in Subjects With Rheumatoid Arthritis | Biotech Hunter | Biotech Hunter