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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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
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Colorado Springs, Colorado 80910
Phone: 719-475-9616
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Amarillo, Texas 79124
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Brandon, Florida 33511
Phone: 813-651-4441
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Charleston, South Carolina 29406
Phone: 843-572-1818
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Charlotte, North Carolina 28207
Phone: 704-342-0252
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Dayton, Ohio 45417
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Denver, Colorado 80230
Phone: 303-394-2828
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Duncansville, Pennsylvania 16635
Phone: 814-693-0300
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Edina, Minnesota 55435
Phone: 952-842-9703
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El Cajon, California 92020
Phone: 619-334-4735
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Glendale, Arizona 85304
Phone: 602-386-4969
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Glendale, Wisconsin 53217
Phone: 414-351-4009
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Greenville, North Carolina 27834
Phone: 252-413-6617
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Greenville, South Carolina 29601
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Houston, Texas 77098
Phone: 713-333-9323
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Huntsville, Alabama 35801
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Las Vegas, Nevada 89128
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Lexington, Kentucky 40504
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Lincoln, Nebraska 68512
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Long Beach, California 90806
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Meridian, Idaho 83642
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Mesa, Arizona 85202
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Miami, Florida 33130
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München, Bayern 80639
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Oklahoma City, Oklahoma 73103
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Oklahoma City, Oklahoma 73103
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Orlando, Florida 32804
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Palm Harbor, Florida 34684
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Palm Harbor, Florida 34684
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Phoenix, Arizona 85037
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San Antonio, Texas 78232
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Santa Maria, California 93454
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Tampa, Florida 33609
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Thousand Oaks, California 91360
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Tupelo, Mississippi 38801
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Tuscaloosa, Alabama 35406
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Upland, California 91786
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Wyomissing, Pennsylvania 19610
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Zephyrhills, Florida 33542
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