GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®

Rheumatoid Arthritis Clinical Trial

— ASSIST-RT  

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®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02514772
• Other study ID #: GP13-302
• Status: Completed
• Phase: Phase 3
• First received: July 30, 2015
• Last updated: November 30, 2017
• Start date: July 2015
• Est. completion date: October 2016

Study information

• Verified date: November 2017
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• GP2013 - A Proposed biosimilar rituximab

• Originator rituximab - Rituxan ® or MabThera ®

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Sandoz	Hexal AG

Countries where clinical trial is conducted

United States,  Germany,  Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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)