GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera® (ASSIST-RT)
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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
Sites / Locations
- Rheumatology Associates of North Alabama, PC
- Clinical and Translational Research Center of Alabama PC
- Arizona Arthritis & Rheumatology Research, PLLC
- Arizona Arthritis and Rheumatology Research, PLLC
- Arizona Arthritis & Rheumatology Research, PLLC
- Arizona Arthritis and Rheumatology Research, PLLC
- TriWest Research Associates, LLC
- Valerius Medical Group and Research Center of Greater Long Beach, Inc
- Pacific Arthritis Center Medical Group
- Westlake Medical Research Inc.
- Inland Rheumatology and Osteoporosis Medical Group
- Arthritis Associates & Osteoporosis Center of Colorado Springs
- Denver Arthritis Clinic
- Bay Area Arthritis and Osteoporosis
- Sunrise Research Institute, Inc.
- Omega Research Consultants, LLC
- Arthritis Center
- Arthritis Research of Florida, Inc.
- Southwest Florida Clinical Research Center
- Florida Medical Clinic, PA
- Idaho Arthritis and Osteoporosis Clinic
- Bluegrass Community Research, Inc.
- Arthritis and Rheumatology Consultants, P.A.
- North Mississippi Medical Clinical, Inc
- Physician Research Collaboration, LLC
- Innovative Health Research
- Arthritis and Osteoporosis Consultants of The Carolinas
- Physicians East, PA
- STAT Research Inc.
- Arthritis & Rheumatology Center of Oklahoma, PLLC
- Health Research of Oklahoma
- Altoona Center For Clinical Research
- Emkey Arthritis and Osteoporosis Clinic, PC
- Low Country Rheumatology, PA
- Piedmont Arthritis Clinic, PA
- Amarillo Center for Clinical Research, Ltd.
- Pioneer Research Solutions, Inc.
- Arthritis and Osteoporosis Center of South Texas
- Rheumatic Disease Center
- Praxis Prof. Herbert Kellner
- Praxiszentrum St. Bonifatius
- Rheumahaus - GbR
- Universitätsklinikum Frankfurt
- Gemeinschaftspraxis Dr. von Hinüber, Dr. Demary
- Klinikum Porz am Rhein
- Schwerpunktpraxis Rheumatologie
- MVZ Ambulantes Rheumazentrum Erfurt
- Rheumatology Center Prof. Neeck
- Rheumapraxis Steglitz
- Immanuel Krankenhaus Berlin, Standort Berlin-Buch
- Rheumatologisches MVZ Dresden GmbH
- Rheumatologie im Struensee-Haus
- LMU Klinikum der Universität München
- Studienambulanz Dr. Wassenberg
- Universitätsklinikum Würzburg
- Országos Reumatológiai És Fizioterápiás Intézet
- QUALICLINIC Kft
- Csongrád Megyei Dr. Bugyi István Kórház
- MÁV Kórház és Rendelőintézet Szolnok
- Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
- Twoja Przychodnia - Centrum Medyczne Nowa Sol
- Slaskie Centrum Reumatologii, Rehabilitacji i Zapobiegania Niepelnosprawnosci im gen. Jerzego Zietka
- Linea Corporis Chirurgia Plastyczna
- Medycyna Kliniczna Marzena Waszczak
- Centrum Medyczne AMED
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
GP2013 - 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).
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).