Clinical trial NCT02514772: GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®
Official title: 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®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
Collaborators: name: Hexal AG
First posted: 2015-08-04
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Patients Experiencing Anaphylactic Reactions
timeFrame: Within 24 hours of each study drug infusion: on Day 1 and Day 14
measure: Number of Patients Experiencing Hypersensitivity Reactions
timeFrame: 24 weeks study duration
measure: Immunogenicity
timeFrame: 24 weeks study duration
measure: Number of Patients Experiencing Potential Infusion-Related Reactions
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rheumatology Associates of North Alabama, PC
state: Alabama
city: Tuscaloosa
country: United States
facility: Clinical and Translational Research Center of Alabama PC
state: Alabama
city: Glendale
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Mesa
country: United States
facility: Arizona Arthritis and Rheumatology Research, PLLC
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis and Rheumatology Research, PLLC
state: Arizona
city: El Cajon
country: United States
facility: TriWest Research Associates, LLC
state: California
city: Long Beach
country: United States
facility: Valerius Medical Group and Research Center of Greater Long Beach, Inc
state: California
city: Santa Maria
country: United States
facility: Pacific Arthritis Center Medical Group
state: California
city: Thousand Oaks
country: United States
facility: Westlake Medical Research Inc.
state: California
city: Upland
country: United States
facility: Inland Rheumatology and Osteoporosis Medical Group
state: California
city: Colorado Springs
country: United States
facility: Arthritis Associates & Osteoporosis Center of Colorado Springs
state: Colorado
city: Denver
country: United States
facility: Denver Arthritis Clinic
state: Colorado
city: Brandon
country: United States
facility: Bay Area Arthritis and Osteoporosis
state: Florida
city: Miami
country: United States
facility: Sunrise Research Institute, Inc.
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants, LLC
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Center
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Research of Florida, Inc.
state: Florida
city: Tampa
country: United States
facility: Southwest Florida Clinical Research Center
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, PA
state: Florida
city: Meridian
country: United States
facility: Idaho Arthritis and Osteoporosis Clinic
state: Idaho
city: Lexington
country: United States
facility: Bluegrass Community Research, Inc.
state: Kentucky
city: Edina
country: United States
facility: Arthritis and Rheumatology Consultants, P.A.
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Medical Clinical, Inc
state: Mississippi
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Innovative Health Research
state: Nevada
city: Charlotte
country: United States
facility: Arthritis and Osteoporosis Consultants of The Carolinas
state: North Carolina
city: Greenville
country: United States
facility: Physicians East, PA
state: North Carolina
city: Dayton
country: United States
facility: STAT Research Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Arthritis & Rheumatology Center of Oklahoma, PLLC
state: Oklahoma
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Wyomissing
country: United States
facility: Emkey Arthritis and Osteoporosis Clinic, PC
state: Pennsylvania
city: Charleston
country: United States
facility: Low Country Rheumatology, PA
state: South Carolina
city: Greenville
country: United States
facility: Piedmont Arthritis Clinic, PA
state: South Carolina
city: Amarillo
country: United States
facility: Amarillo Center for Clinical Research, Ltd.
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: San Antonio
country: United States
facility: Arthritis and Osteoporosis Center of South Texas
state: Texas
city: Glendale
country: United States
facility: Rheumatic Disease Center
state: Wisconsin
city: München
country: Germany
facility: Praxis Prof. Herbert Kellner
state: Bayern
city: München
country: Germany
facility: Praxiszentrum St. Bonifatius
state: Bayern
city: Potsdam
country: Germany
facility: Rheumahaus - GbR
state: Brandenburg
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt
state: Hessen
city: Hildesheim
country: Germany
facility: Gemeinschaftspraxis Dr. von Hinüber, Dr. Demary
state: Niedersachsen
city: Köln
country: Germany
facility: Klinikum Porz am Rhein
state: Nordrhein-Westfalen
city: Rendsburg
country: Germany
facility: Schwerpunktpraxis Rheumatologie
state: Schleswig-Holstein
city: Erfurt
country: Germany
facility: MVZ Ambulantes Rheumazentrum Erfurt
state: Thüringen
city: Bad Doberan
country: Germany
facility: Rheumatology Center Prof. Neeck
city: Berlin
country: Germany
facility: Rheumapraxis Steglitz
city: Berlin
country: Germany
facility: Immanuel Krankenhaus Berlin, Standort Berlin-Buch
city: Dresden
country: Germany
facility: Rheumatologisches MVZ Dresden GmbH
city: Hamburg
country: Germany
facility: Rheumatologie im Struensee-Haus
city: München
country: Germany
facility: LMU Klinikum der Universität München
city: Ratingen
country: Germany
facility: Studienambulanz Dr. Wassenberg
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Budapest
country: Hungary
facility: Országos Reumatológiai És Fizioterápiás Intézet
city: Budapest
country: Hungary
facility: QUALICLINIC Kft
city: Szentes
country: Hungary
facility: Csongrád Megyei Dr. Bugyi István Kórház
city: Szolnok
country: Hungary
facility: MÁV Kórház és Rendelőintézet Szolnok
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
city: Nowa Sol
country: Poland
facility: Twoja Przychodnia - Centrum Medyczne Nowa Sol
city: Ustron
country: Poland
facility: Slaskie Centrum Reumatologii, Rehabilitacji i Zapobiegania Niepelnosprawnosci im gen. Jerzego Zietka
city: Warszawa
country: Poland
facility: Linea Corporis Chirurgia Plastyczna
city: Warszawa
country: Poland
facility: Medycyna Kliniczna Marzena Waszczak
city: Warszawa
country: Poland
facility: Centrum Medyczne AMED
Study officials:
affiliation: Sponsor GmbH
name: Sandoz Inc.
role: STUDY_CHAIR
References:
citation: 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.