GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®
- Conditions
- Rheumatoid Arthritis
- Interventions
- Biological: GP2013 - A Proposed biosimilar rituximabBiological: Originator rituximab - Rituxan ® or MabThera ®
- Registration Number
- NCT02514772
- Lead Sponsor
- Sandoz
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 107
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GP2013 - proposed biosimilar rituximab GP2013 - A 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). Originator rituximab - Rituxan ® or MabThera ® 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).
- Primary Outcome Measures
Name Time Method Number of Patients Experiencing Anaphylactic Reactions Within 24 hours of each study drug infusion: on Day 1 and Day 14 2006 NIAID/FAAN\* criteria were used for identification of anaphylactic reactions within 24h of each study drug infusion.
For patients with no history of infusion-related reactions during their previous treatments with rituximab, symptoms/signs in at least 2 out of 4 organ systems:
* Skin/mucosal tissue
* Respiratory organs
* Drop of systolic blood pressure (\<90 mmHg or variance from baseline \>30%) or associated symptoms
* Gastrointestinal organs were defined as an anaphylactic reaction.
The same criteria were also applied to patients with history of infusion-related reactions during their previous treatments with rituximab. In addition, if these patients experienced only a rapid drop in systolic blood pressure (\<90 mmHg or variance from baseline \>30%), this was defined as an anaphylactic reaction disregarding involvement of other organ systems.
\* NIAID - National Institute of Allergy and Infectious Diseases FAAN - Food Allergy and Anaphylaxis NetworkNumber of Patients Experiencing Potential Infusion-Related Reactions On the day of and on the day after each study drug infusion (e.g. on study day 1 and 2 for the 1st study drug infusion and on study day 14 and 15 for the 2nd study drug infusion, if the second drug infusion was given on study day 14) Patients, experienced infusion related reactions repeatedly (i.e. during the first and second infusion) are counted only once in the overall line.
Number of Patients Experiencing Hypersensitivity Reactions 24 weeks study duration The standardized MedDRA query (SMQ) - Hypersensitivity reactions (SMQ 20000214) was used for the identification of hypersensitivity reactions overall from first infusion in the adverse event database.
Immunogenicity 24 weeks study duration Number of patients tested positive for anti-drug-antibodies (ADA) post-randomization.
Patients with negative ADA results at screening and at least one evaluable post-randomization ADA assessment are included in the analysis
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (63)
Physician Research Collaboration, LLC
🇺🇸Lincoln, Nebraska, United States
Physicians East, PA
🇺🇸Greenville, North Carolina, United States
Omega Research Consultants, LLC
🇺🇸Orlando, Florida, United States
Arthritis Research of Florida, Inc.
🇺🇸Palm Harbor, Florida, United States
Clinical and Translational Research Center of Alabama PC
🇺🇸Tuscaloosa, Alabama, United States
Arthritis and Osteoporosis Consultants of The Carolinas
🇺🇸Charlotte, North Carolina, United States
Amarillo Center for Clinical Research, Ltd.
🇺🇸Amarillo, Texas, United States
Bluegrass Community Research, Inc.
🇺🇸Lexington, Kentucky, United States
Valerius Medical Group and Research Center of Greater Long Beach, Inc
🇺🇸Long Beach, California, United States
Altoona Center For Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Westlake Medical Research Inc.
🇺🇸Thousand Oaks, California, United States
STAT Research Inc.
🇺🇸Dayton, Ohio, United States
Rheumatology Associates of North Alabama, PC
🇺🇸Huntsville, Alabama, United States
Arthritis Center
🇺🇸Palm Harbor, Florida, United States
Arthritis & Rheumatology Center of Oklahoma, PLLC
🇺🇸Oklahoma City, Oklahoma, United States
Klinikum Porz am Rhein
🇩🇪Köln, Nordrhein-Westfalen, Germany
TriWest Research Associates, LLC
🇺🇸El Cajon, California, United States
Arthritis and Rheumatology Consultants, P.A.
🇺🇸Edina, Minnesota, United States
Emkey Arthritis and Osteoporosis Clinic, PC
🇺🇸Wyomissing, Pennsylvania, United States
Rheumapraxis Steglitz
🇩🇪Berlin, Germany
Rheumatologie im Struensee-Haus
🇩🇪Hamburg, Germany
Health Research of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Piedmont Arthritis Clinic, PA
🇺🇸Greenville, South Carolina, United States
Rheumatologisches MVZ Dresden GmbH
🇩🇪Dresden, Germany
Linea Corporis Chirurgia Plastyczna
🇵🇱Warszawa, Poland
Praxis Prof. Herbert Kellner
🇩🇪München, Bayern, Germany
QUALICLINIC Kft
🇭🇺Budapest, Hungary
Praxiszentrum St. Bonifatius
🇩🇪München, Bayern, Germany
Csongrád Megyei Dr. Bugyi István Kórház
🇭🇺Szentes, Hungary
Rheumatology Center Prof. Neeck
🇩🇪Bad Doberan, Germany
Gemeinschaftspraxis Dr. von Hinüber, Dr. Demary
🇩🇪Hildesheim, Niedersachsen, Germany
Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany
Arthritis Associates & Osteoporosis Center of Colorado Springs
🇺🇸Colorado Springs, Colorado, United States
Schwerpunktpraxis Rheumatologie
🇩🇪Rendsburg, Schleswig-Holstein, Germany
Bay Area Arthritis and Osteoporosis
🇺🇸Brandon, Florida, United States
Inland Rheumatology and Osteoporosis Medical Group
🇺🇸Upland, California, United States
Pacific Arthritis Center Medical Group
🇺🇸Santa Maria, California, United States
Southwest Florida Clinical Research Center
🇺🇸Tampa, Florida, United States
Arthritis and Osteoporosis Center of South Texas
🇺🇸San Antonio, Texas, United States
Rheumahaus - GbR
🇩🇪Potsdam, Brandenburg, Germany
MVZ Ambulantes Rheumazentrum Erfurt
🇩🇪Erfurt, Thüringen, Germany
Immanuel Krankenhaus Berlin, Standort Berlin-Buch
🇩🇪Berlin, Germany
Studienambulanz Dr. Wassenberg
🇩🇪Ratingen, Germany
Slaskie Centrum Reumatologii, Rehabilitacji i Zapobiegania Niepelnosprawnosci im gen. Jerzego Zietka
🇵🇱Ustron, Poland
Twoja Przychodnia - Centrum Medyczne Nowa Sol
🇵🇱Nowa Sol, Poland
Arizona Arthritis & Rheumatology Research, PLLC
🇺🇸Phoenix, Arizona, United States
Idaho Arthritis and Osteoporosis Clinic
🇺🇸Meridian, Idaho, United States
Arizona Arthritis and Rheumatology Research, PLLC
🇺🇸Phoenix, Arizona, United States
Innovative Health Research
🇺🇸Las Vegas, Nevada, United States
North Mississippi Medical Clinical, Inc
🇺🇸Tupelo, Mississippi, United States
Rheumatic Disease Center
🇺🇸Glendale, Wisconsin, United States
MÁV Kórház és Rendelőintézet Szolnok
🇭🇺Szolnok, Hungary
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
🇵🇱Bydgoszcz, Poland
Low Country Rheumatology, PA
🇺🇸Charleston, South Carolina, United States
Medycyna Kliniczna Marzena Waszczak
🇵🇱Warszawa, Poland
Országos Reumatológiai És Fizioterápiás Intézet
🇭🇺Budapest, Hungary
Centrum Medyczne AMED
🇵🇱Warszawa, Poland
Universitätsklinikum Frankfurt
🇩🇪Frankfurt am Main, Hessen, Germany
LMU Klinikum der Universität München
🇩🇪München, Germany
Sunrise Research Institute, Inc.
🇺🇸Miami, Florida, United States
Florida Medical Clinic, PA
🇺🇸Zephyrhills, Florida, United States
Pioneer Research Solutions, Inc.
🇺🇸Houston, Texas, United States
Denver Arthritis Clinic
🇺🇸Denver, Colorado, United States