Comparative Pharmacokinetic, Pharmacodynamic, Safety and Efficacy Study of Three Anti-CD20 Monoclonal Antibodies in Patients With Moderate to Severe Rheumatoid Arthritis

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

276

Participants

Timeline

Start Date

November 30, 2014

Primary Completion Date

November 30, 2016

Study Completion Date

October 5, 2017

Conditions
Rheumatoid Arthritis
Interventions
BIOLOGICAL

DRL_RI

Two 1000 mg intravenous infusions, one each on Day 1 and Day 15

BIOLOGICAL

Rituxan

Two 1000 mg intravenous infusions, one each on Day 1 and Day 15

BIOLOGICAL

MabThera

Two 1000 mg intravenous infusions, one each on Day 1 and Day 15

Trial Locations (28)

21018

Vinnytsia M.I. Pyrogov Regional Clinical Hospital, Vinnytsia

21029

Medical Clinical Investigational Center MC LLC Health Clinic, Vinnytsia

36011

M.V. Sklifosovskyi Poltava Regional Clinical Hospital, Poltava

61176

Communal Healthcare Institution Kharkiv City Clinical Hospital #8, Kharkiv

69600

Communal Institution Zaporzhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council, Zaporizhzhia

110002

Maulana Azad Medical College & Associated Lok Nayak Hospitals, New Delhi

110076

lndraprastha Apollo Hospitals, New Delhi

141001

Dayanand Medical College & Hosptial, Ludhiana

226018

King George's Medical University, Lucknow

302001

S. R. Kalla Memorial Gastro & General Hospital, Jaipur

302006

Shri Nidaan Hospital & Hope Fertility Centre, Jaipur

380015

Shalby Hospitals, Ahmedabad

395001

Government Medical College & New Civil Hospital, Surat

400053

Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute, Mumbai

411001

Jehangir Clinical Development Centre Pvt. Ltd., Pune

411004

Deennath Mangeshkar Hospital and Research Centre, Pune

411005

Oyster & Pearl Hospital, Pune

411040

lnamdar Multispeciality Hospital, Pune

500003

Krishna Institute of Medical Sciences Ltd., Secunderabad

Yashoda Hospital, Secunderabad

500020

Gurunank Care Hospital, Hyderabad

500034

Care Hospitals, Hyderabad

560079

Chanre Rheumatology & Immunology Center & Research, Bangalore

570004

Jagadguru Sri Shivarathreeshwara Hospital, Mysore

625020

Apollo Specialty Hosptials, Madurai

5880021

Sushruta Multispeciality Hospital & Research Centre Pvt. Ltd, Hubli

03680

State Institution National Scientific Center Acad. Strazhesko Institute of Cardiology of National Academy of Medical Science, Kyiv

04114

State Institution D.F. Chebotariov Institute of Gerontology of NAMS of Ukraine, Kyiv

All Listed Sponsors
lead

Dr. Reddy's Laboratories Limited

INDUSTRY