PK, PD, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis

PHASE1CompletedINTERVENTIONAL
Enrollment

294

Participants

Timeline

Start Date

October 11, 2016

Primary Completion Date

April 30, 2018

Study Completion Date

November 7, 2018

Conditions
Rheumatoid Arthritis
Interventions
BIOLOGICAL

SAIT101

1,000 mg i.v. of SAIT101 on Day 1 and 15. 1,000 mg i.v. of SAIT101 on week 24 and 26 for eligible patients.

BIOLOGICAL

MabThera

1,000 mg i.v. of MabThera® on Day 1 and 15. 1,000 mg i.v. of MabThera® on week 24 and 26 for eligible patients.

BIOLOGICAL

Rituxan

1,000 mg i.v. of Rituxan® on Day 1 and 15. 1,000 mg i.v. of Rituxan® on week 24 and 26 for eligible patients.

Trial Locations (75)

1027

Research Site, Budapest

1083

Research Site, Budapest

1336

Research Site, Sofia

1612

Research Site, Sofia

4002

Research Site-1, Plovdiv

Research Site-2, Plovdiv

14068

Research Site, Anyang

15006

Research Site, A Coruña

15702

Research Site, A Coruña

15706

Research Site, A Coruña

16247

Research Site, Suwon

18209

Research site, Bad Doberan

22143

Research site, Hamburg

24768

Research site, Rendsburg

28942

Research Site, Fuenlabrada

32804

Research Site, Orlando

33612

Research Site, Tampa

33613

Research Site, Tampa

34000

Research Site, Durango

35015

Research Site, Daejeon

36207

Research Site, Anniston

39245

Research site, Vogelsang

40882

Research site, Ratingen

41010

Research Site, Seville

41014

Research Site, Seville

41944

Research Site, Daegu

42472

Research Site, Daegu

48917

Research Site, Lansing

49201

Research Site, Busan

49241

Research Site, Busan

61469

Research Site, Gwangju

63241

Research Site, Jeju City

66160

Research Site, Kansas City

71000

Research site, Sarajevo

76710

Research Site, Waco

83642

Research Site, Boise

88000

Research Site, Mostar

90017

Research Site-1, Los Angeles

Research Site-2, Los Angeles

90712

Research Site, Lakewood

91942

Research Site, La Mesa

92020

Research Site, El Cajon

94578

Research Site, San Leandro

98405

Research Site, Tacoma

302001

Research site, Jaipur

334003

Research site, Bikaner

411001

Research site, Pune

411005

Research site, Pune

411007

Research site, Pune

560054

Research site, Bangalore

580021

Research site, Hubli

700107

Research site, Kolkata

656 91

Research site, Brno

702 00

Research site, Ostrava

128 50

Research site, Prague

686 01

Research site, Uherské Hradiště

01067

Research site, Dresden

06700

Research Site, Mexico City

07020

Research Site, Mexico City

80-952

Research site, Gdansk

30-033

Research site, Krakow

30-363

Research site, Krakow

57-300

Research site, Kłodzko

67-100

Research site, Nowa Sól

32-600

Research site, Oświęcim

60-773

Research site, Poznan

61-113

Research site, Poznan

43-100

Research site, Tychy

00-660

Research site, Warsaw

03-291

Research site, Warsaw

51-128

Research site, Wroclaw

22-400

Research site, Zamość

03080

Research Site, Seoul

04763

Research Site, Seoul

07061

Research Site, Seoul

All Listed Sponsors
lead

Archigen Biotech Limited

INDUSTRY

NCT02819726 - PK, PD, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis | Biotech Hunter | Biotech Hunter