GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®
NCT ID: NCT02514772
Last Updated: 2017-12-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
107 participants
INTERVENTIONAL
2015-07-31
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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GP2013 - proposed biosimilar rituximab
10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration, two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v. The treatment course consists of 2 i.v. infusions 2 weeks apart (at Day 1 and Day 14).
GP2013 - A Proposed biosimilar rituximab
Originator rituximab - Rituxan ® or MabThera ®
10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v. The treatment course consists of 2 i.v. infusions 2 weeks apart (at Day 1 and Day 14).
Originator rituximab - Rituxan ® or MabThera ®
Interventions
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GP2013 - A Proposed biosimilar rituximab
Originator rituximab - Rituxan ® or MabThera ®
Eligibility Criteria
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Inclusion 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
* Systemic manifestation of RA
* Positive serology for hepatitis B or hepatitis C infection
* Active systemic infection
* History of cancer
* Known severely immunocompromised state
18 Years
ALL
No
Sponsors
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Hexal AG
INDUSTRY
Sandoz
INDUSTRY
Responsible Party
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Principal Investigators
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Sandoz Inc.
Role: STUDY_CHAIR
Sponsor GmbH
Locations
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Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, United States
Clinical and Translational Research Center of Alabama PC
Tuscaloosa, Alabama, United States
Arizona Arthritis & Rheumatology Research, PLLC
Glendale, Arizona, United States
Arizona Arthritis and Rheumatology Research, PLLC
Mesa, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, United States
Arizona Arthritis and Rheumatology Research, PLLC
Phoenix, Arizona, United States
TriWest Research Associates, LLC
El Cajon, California, United States
Valerius Medical Group and Research Center of Greater Long Beach, Inc
Long Beach, California, United States
Pacific Arthritis Center Medical Group
Santa Maria, California, United States
Westlake Medical Research Inc.
Thousand Oaks, California, United States
Inland Rheumatology and Osteoporosis Medical Group
Upland, California, United States
Arthritis Associates & Osteoporosis Center of Colorado Springs
Colorado Springs, Colorado, United States
Denver Arthritis Clinic
Denver, Colorado, United States
Bay Area Arthritis and Osteoporosis
Brandon, Florida, United States
Sunrise Research Institute, Inc.
Miami, Florida, United States
Omega Research Consultants, LLC
Orlando, Florida, United States
Arthritis Center
Palm Harbor, Florida, United States
Arthritis Research of Florida, Inc.
Palm Harbor, Florida, United States
Southwest Florida Clinical Research Center
Tampa, Florida, United States
Florida Medical Clinic, PA
Zephyrhills, Florida, United States
Idaho Arthritis and Osteoporosis Clinic
Meridian, Idaho, United States
Bluegrass Community Research, Inc.
Lexington, Kentucky, United States
Arthritis and Rheumatology Consultants, P.A.
Edina, Minnesota, United States
North Mississippi Medical Clinical, Inc
Tupelo, Mississippi, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, United States
Innovative Health Research
Las Vegas, Nevada, United States
Arthritis and Osteoporosis Consultants of The Carolinas
Charlotte, North Carolina, United States
Physicians East, PA
Greenville, North Carolina, United States
STAT Research Inc.
Dayton, Ohio, United States
Arthritis & Rheumatology Center of Oklahoma, PLLC
Oklahoma City, Oklahoma, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Emkey Arthritis and Osteoporosis Clinic, PC
Wyomissing, Pennsylvania, United States
Low Country Rheumatology, PA
Charleston, South Carolina, United States
Piedmont Arthritis Clinic, PA
Greenville, South Carolina, United States
Amarillo Center for Clinical Research, Ltd.
Amarillo, Texas, United States
Pioneer Research Solutions, Inc.
Houston, Texas, United States
Arthritis and Osteoporosis Center of South Texas
San Antonio, Texas, United States
Rheumatic Disease Center
Glendale, Wisconsin, United States
Praxis Prof. Herbert Kellner
München, Bavaria, Germany
Praxiszentrum St. Bonifatius
München, Bavaria, Germany
Rheumahaus - GbR
Potsdam, Brandenburg, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, Germany
Gemeinschaftspraxis Dr. von Hinüber, Dr. Demary
Hildesheim, Lower Saxony, Germany
Klinikum Porz am Rhein
Cologne, North Rhine-Westphalia, Germany
Schwerpunktpraxis Rheumatologie
Rendsburg, Schleswig-Holstein, Germany
MVZ Ambulantes Rheumazentrum Erfurt
Erfurt, Thuringia, Germany
Rheumatology Center Prof. Neeck
Bad Doberan, , Germany
Rheumapraxis Steglitz
Berlin, , Germany
Immanuel Krankenhaus Berlin, Standort Berlin-Buch
Berlin, , Germany
Rheumatologisches MVZ Dresden GmbH
Dresden, , Germany
Rheumatologie im Struensee-Haus
Hamburg, , Germany
LMU Klinikum der Universität München
München, , Germany
Studienambulanz Dr. Wassenberg
Ratingen, , Germany
Universitätsklinikum Würzburg
Würzburg, , Germany
Országos Reumatológiai És Fizioterápiás Intézet
Budapest, , Hungary
QUALICLINIC Kft
Budapest, , Hungary
Csongrád Megyei Dr. Bugyi István Kórház
Szentes, , Hungary
MÁV Kórház és Rendelőintézet Szolnok
Szolnok, , Hungary
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, , Poland
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, , Poland
Slaskie Centrum Reumatologii, Rehabilitacji i Zapobiegania Niepelnosprawnosci im gen. Jerzego Zietka
Ustroń, , Poland
Linea Corporis Chirurgia Plastyczna
Warsaw, , Poland
Medycyna Kliniczna Marzena Waszczak
Warsaw, , Poland
Centrum Medyczne AMED
Warsaw, , Poland
Countries
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References
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Tony HP, Kruger K, Cohen SB, Schulze-Koops H, Kivitz AJ, Jeka S, Vereckei E, Cen L, Kring L, Kollins D. Brief Report: Safety and Immunogenicity of Rituximab Biosimilar GP 2013 After Switch From Reference Rituximab in Patients With Active Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2019 Jan;71(1):88-94. doi: 10.1002/acr.23771.
Other Identifiers
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GP13-302
Identifier Type: -
Identifier Source: org_study_id