GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®
ASSIST-RT
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®
1 other identifier
interventional
107
4 countries
65
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 rheumatoid-arthritis
Started Jul 2015
Shorter than P25 for phase_3 rheumatoid-arthritis
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 30, 2015
CompletedFirst Posted
Study publicly available on registry
August 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedResults Posted
Study results publicly available
December 28, 2017
CompletedDecember 28, 2017
November 1, 2017
1 year
July 30, 2015
October 11, 2017
November 30, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
Number of Patients Experiencing Anaphylactic Reactions
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 Network
Within 24 hours of each study drug infusion: on Day 1 and Day 14
Number of Patients Experiencing Hypersensitivity Reactions
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.
24 weeks study duration
Immunogenicity
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
24 weeks study duration
Number of Patients Experiencing Potential Infusion-Related Reactions
Patients, experienced infusion related reactions repeatedly (i.e. during the first and second infusion) are counted only once in the overall line.
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)
Study Arms (2)
GP2013 - proposed biosimilar rituximab
EXPERIMENTAL10 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 ®
ACTIVE COMPARATOR10 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).
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (65)
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, 35801, United States
Clinical and Translational Research Center of Alabama PC
Tuscaloosa, Alabama, 35406, United States
Arizona Arthritis & Rheumatology Research, PLLC
Glendale, Arizona, 85306, United States
Arizona Arthritis and Rheumatology Research, PLLC
Mesa, Arizona, 85202, United States
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, 85032, United States
Arizona Arthritis and Rheumatology Research, PLLC
Phoenix, Arizona, 85037, United States
TriWest Research Associates, LLC
El Cajon, California, 92020, United States
Valerius Medical Group and Research Center of Greater Long Beach, Inc
Long Beach, California, 90806, United States
Pacific Arthritis Center Medical Group
Santa Maria, California, 93454, United States
Westlake Medical Research Inc.
Thousand Oaks, California, 91360, United States
Inland Rheumatology and Osteoporosis Medical Group
Upland, California, 91786, United States
Arthritis Associates & Osteoporosis Center of Colorado Springs
Colorado Springs, Colorado, 80920, United States
Denver Arthritis Clinic
Denver, Colorado, 80230, United States
Bay Area Arthritis and Osteoporosis
Brandon, Florida, 33511, United States
Sunrise Research Institute, Inc.
Miami, Florida, 33130, United States
Omega Research Consultants, LLC
Orlando, Florida, 32804, United States
Arthritis Center
Palm Harbor, Florida, 34684, United States
Arthritis Research of Florida, Inc.
Palm Harbor, Florida, 34684, United States
Southwest Florida Clinical Research Center
Tampa, Florida, 33609, United States
Florida Medical Clinic, PA
Zephyrhills, Florida, 33542, United States
Idaho Arthritis and Osteoporosis Clinic
Meridian, Idaho, 83642, United States
Bluegrass Community Research, Inc.
Lexington, Kentucky, 40504, United States
Arthritis and Rheumatology Consultants, P.A.
Edina, Minnesota, 55435, United States
North Mississippi Medical Clinical, Inc
Tupelo, Mississippi, 38801, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516, United States
Innovative Health Research
Las Vegas, Nevada, 89128, United States
Arthritis and Osteoporosis Consultants of The Carolinas
Charlotte, North Carolina, 28207, United States
Physicians East, PA
Greenville, North Carolina, 27834, United States
STAT Research Inc.
Dayton, Ohio, 45417, United States
Arthritis & Rheumatology Center of Oklahoma, PLLC
Oklahoma City, Oklahoma, 73103, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, 73103, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635, United States
Emkey Arthritis and Osteoporosis Clinic, PC
Wyomissing, Pennsylvania, 19610, United States
Low Country Rheumatology, PA
Charleston, South Carolina, 29406, United States
Piedmont Arthritis Clinic, PA
Greenville, South Carolina, 29601, United States
Amarillo Center for Clinical Research, Ltd.
Amarillo, Texas, 79124, United States
Pioneer Research Solutions, Inc.
Houston, Texas, 77099, United States
Arthritis and Osteoporosis Center of South Texas
San Antonio, Texas, 78232, United States
Rheumatic Disease Center
Glendale, Wisconsin, 53217, United States
Praxis Prof. Herbert Kellner
München, Bavaria, 80639, Germany
Praxiszentrum St. Bonifatius
München, Bavaria, 81541, Germany
Rheumahaus - GbR
Potsdam, Brandenburg, 14469, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, 60528, Germany
Gemeinschaftspraxis Dr. von Hinüber, Dr. Demary
Hildesheim, Lower Saxony, 31134, Germany
Klinikum Porz am Rhein
Cologne, North Rhine-Westphalia, 51149, Germany
Schwerpunktpraxis Rheumatologie
Rendsburg, Schleswig-Holstein, 24768, Germany
MVZ Ambulantes Rheumazentrum Erfurt
Erfurt, Thuringia, 99096, Germany
Rheumatology Center Prof. Neeck
Bad Doberan, 18209, Germany
Rheumapraxis Steglitz
Berlin, 12161, Germany
Immanuel Krankenhaus Berlin, Standort Berlin-Buch
Berlin, 13125, Germany
Rheumatologisches MVZ Dresden GmbH
Dresden, 01109, Germany
Rheumatologie im Struensee-Haus
Hamburg, 22767, Germany
LMU Klinikum der Universität München
München, 80336, Germany
Studienambulanz Dr. Wassenberg
Ratingen, 40882, Germany
Universitätsklinikum Würzburg
Würzburg, 97080, Germany
Országos Reumatológiai És Fizioterápiás Intézet
Budapest, 1023, Hungary
QUALICLINIC Kft
Budapest, 1036, Hungary
Csongrád Megyei Dr. Bugyi István Kórház
Szentes, 6600, Hungary
MÁV Kórház és Rendelőintézet Szolnok
Szolnok, 5000, Hungary
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168, Poland
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, 67 -100, Poland
Slaskie Centrum Reumatologii, Rehabilitacji i Zapobiegania Niepelnosprawnosci im gen. Jerzego Zietka
Ustroń, 43-450, Poland
Linea Corporis Chirurgia Plastyczna
Warsaw, 00-235, Poland
Medycyna Kliniczna Marzena Waszczak
Warsaw, 00660, Poland
Centrum Medyczne AMED
Warsaw, 01-518, Poland
Related Publications (1)
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.
PMID: 30295429DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Program Medical Director
- Organization
- Sandoz
Study Officials
- STUDY CHAIR
Sandoz Inc.
Sponsor GmbH
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2015
First Posted
August 4, 2015
Study Start
July 1, 2015
Primary Completion
July 1, 2016
Study Completion
October 1, 2016
Last Updated
December 28, 2017
Results First Posted
December 28, 2017
Record last verified: 2017-11