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

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