GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:12/30/2017
Start Date:July 2015
End Date:October 2016

Use our guide to learn which trials are right for you!

Trial Summary
Trial Overview
Inclusion Criteria

A Randomized, Double- Blind, Controlled, Parallel-group, Multicenter Study to Assess the Safety and Immunogenicity of Transitioning to GP2013 or Re-treatment With Rituxan® or MabThera® in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®

The study objective is to identify potential safety risks of the transition from US-licensed
Rituxan® or EU-approved MabThera® to GP2013 (proposed biosimilar product) as compared to
continuous treatment with the originator product in terms of general safety and
immunogenicity.


Inclusion Criteria:

- Diagnosis of rheumatoid arthritis (RA) according to ACR 2010 criteria

- Completed one full treatment course with either Rituxan® or MabThera®

- Eligible for a further treatment course with Rituxan® or MabThera®- Currently treated
with methotrexate

Exclusion Criteria:

- RA functional status class IV (ACR 1991 revised criteria)

- Systemic manifestation of RA

- Positive serology for hepatitis B or hepatitis C infection

- Active systemic infection

- History of cancer

- Known severely immunocompromised state

Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
40
sites
Rheumatology Associates Of North Alabama, P.C.
Huntsville, Alabama 35801
Phone: 256-704-7098
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
Amarillo Center for Clinical Research
Amarillo, Texas 79124
Phone: 806-352-2453
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
Bay Area Arthritis and Osteoporosis
Brandon, Florida 33511
Phone: 813-651-4441
?
mi
from
Brandon, FL
Click here to add this to my saved trials
Low Country Rheumatology
Charleston, South Carolina 29406
Phone: 843-572-1818
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina 28207
Phone: 704-342-0252
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Arthritis Associates And Osteoporosis Center Of Colorado Springs
Colorado Springs, Colorado 80910
Phone: 719-475-9616
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
STAT Research, Inc.
Dayton, Ohio 45417
Phone: 937-223-4229
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Denver Arthritis Clinic
Denver, Colorado 80230
Phone: 303-394-2828
?
mi
from
Denver, CO
Click here to add this to my saved trials
Altoona Center for Clinical Research
Duncansville, Pennsylvania 16635
Phone: 814-693-0300
?
mi
from
Duncansville, PA
Click here to add this to my saved trials
Arthritis and Rheumatology Consultants, P.A.
Edina, Minnesota 55435
Phone: 952-842-9703
?
mi
from
Edina, MN
Click here to add this to my saved trials
TriWest Research Associates, LLC
El Cajon, California 92020
Phone: 619-334-4735
?
mi
from
El Cajon, CA
Click here to add this to my saved trials
Arizona Arthritis and Rheumatology Research
Glendale, Arizona 85304
Phone: 602-386-4969
?
mi
from
Glendale, AZ
Click here to add this to my saved trials
Rheumatic Disease Center
Glendale, Wisconsin 53217
Phone: 414-351-4009
?
mi
from
Glendale, WI
Click here to add this to my saved trials
Physician's East
Greenville, North Carolina 27834
Phone: 252-413-6617
?
mi
from
Greenville, NC
Click here to add this to my saved trials
Piedmont Arthritis Clinic, PA
Greenville, South Carolina 29601
Phone: 864-235-8396
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Pioneer Research Solutions, Inc.
Houston, Texas 77098
Phone: 713-333-9323
?
mi
from
Houston, TX
Click here to add this to my saved trials
Innovative Health Research
Las Vegas, Nevada 89128
Phone: 702-341-5444
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Bluegrass Community Research, Inc
Lexington, Kentucky 40504
Phone: 859-272-1671
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Physician Research Collaboration
Lincoln, Nebraska 68512
Phone: 402-420-1212
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
Valerius Medical Group And Research Center Of Greater Long Beach, Inc.
Long Beach, California 90806
Phone: 562-989-2374
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Idaho Arthritis and Osteoporosis Clinic
Meridian, Idaho 83642
Phone: 208-887-9500
?
mi
from
Meridian, ID
Click here to add this to my saved trials
Arizona Arthritis & Rheumatology Research, PLLC
Mesa, Arizona 85202
Phone: 480-626-6653
?
mi
from
Mesa, AZ
Click here to add this to my saved trials
Sunrise Research Institute, Inc
Miami, Florida 33130
Phone: 786-409-6849
?
mi
from
Miami, FL
Click here to add this to my saved trials
Praxis Prof. Herbert Kellner
München, Bayern 80639
Phone: ??+498913959100
?
mi
from
München,
Click here to add this to my saved trials
Arthritis & Rheumatology Center Of Oklahoma Pllc
Oklahoma City, Oklahoma 73103
Phone: 405-606-8730
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Health Research of Oklahoma
Oklahoma City, Oklahoma 73103
Phone: 405-702-6770
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Omega Research Consultants, Llc
Orlando, Florida 32804
Phone: 407-271-8030
?
mi
from
Orlando, FL
Click here to add this to my saved trials
The Arthritis Center
Palm Harbor, Florida 34684
Phone: 727-789-2784
?
mi
from
Palm Harbor, FL
Click here to add this to my saved trials
Arthritis Research of Florida, Inc.
Palm Harbor, Florida 34684
Phone: 727-210-2555
?
mi
from
Palm Harbor, FL
Click here to add this to my saved trials
Arizona Arthritis & Rheumatology Research PLLC
Phoenix, Arizona 85037
Phone: 602-386-4970
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Arizona Arthritis & Rheumatology Research PLLC
Phoenix, Arizona 85037
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Arthritis and Osteoporosis Center of South Texas
San Antonio, Texas 78232
Phone: 210-403-9545
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Pacific Arthritis Center Medical Group
Santa Maria, California 93454
Phone: 805-925-8899
?
mi
from
Santa Maria, CA
Click here to add this to my saved trials
Southwest Florida Clinical Research Center
Tampa, Florida 33609
Phone: 813-879-1188
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Westlake Medical Research
Thousand Oaks, California 91360
Phone: 805-496-3322
?
mi
from
Thousand Oaks, CA
Click here to add this to my saved trials
North Mississippi Medical Clinical, Inc
Tupelo, Mississippi 38801
Phone: 662-377-5131
?
mi
from
Tupelo, MS
Click here to add this to my saved trials
Clinical and Translational Research Center of Alabama, PC
Tuscaloosa, Alabama 35406
Phone: 205-464-4711
?
mi
from
Tuscaloosa, AL
Click here to add this to my saved trials
Inland Rheumatology and Osteoporosis Medical Group
Upland, California 91786
Phone: 909-982-0099
?
mi
from
Upland, CA
Click here to add this to my saved trials
Emkey Arthritis and Osteoporosis Clinic, PC
Wyomissing, Pennsylvania 19610
Phone: 610-374-8133
?
mi
from
Wyomissing, PA
Click here to add this to my saved trials
Florida Medical Clinic
Zephyrhills, Florida 33542
Phone: 813-780-8368
?
mi
from
Zephyrhills, FL
Click here to add this to my saved trials