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GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera® (ASSIST-RT)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
GP2013 - A Proposed biosimilar rituximab
Originator rituximab - Rituxan ® or MabThera ®
Sponsored by
Sandoz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Arm Label

GP2013 - proposed biosimilar rituximab

Originator rituximab - Rituxan ® or MabThera ®

Arm Description

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).

Outcomes

Primary Outcome Measures

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
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.
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
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.

Secondary Outcome Measures

Full Information

First Posted
July 30, 2015
Last Updated
November 30, 2017
Sponsor
Sandoz
Collaborators
Hexal AG
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1. Study Identification

Unique Protocol Identification Number
NCT02514772
Brief Title
GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®
Acronym
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®
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sandoz
Collaborators
Hexal AG

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GP2013 - proposed biosimilar rituximab
Arm Type
Experimental
Arm Description
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).
Arm Title
Originator rituximab - Rituxan ® or MabThera ®
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
GP2013 - A Proposed biosimilar rituximab
Intervention Type
Biological
Intervention Name(s)
Originator rituximab - Rituxan ® or MabThera ®
Primary Outcome Measure Information:
Title
Number of Patients Experiencing Anaphylactic Reactions
Description
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
Time Frame
Within 24 hours of each study drug infusion: on Day 1 and Day 14
Title
Number of Patients Experiencing Hypersensitivity Reactions
Description
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.
Time Frame
24 weeks study duration
Title
Immunogenicity
Description
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
Time Frame
24 weeks study duration
Title
Number of Patients Experiencing Potential Infusion-Related Reactions
Description
Patients, experienced infusion related reactions repeatedly (i.e. during the first and second infusion) are counted only once in the overall line.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandoz Inc.
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Chair
Facility Information:
Facility Name
Rheumatology Associates of North Alabama, PC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Clinical and Translational Research Center of Alabama PC
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35406
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Arizona Arthritis and Rheumatology Research, PLLC
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Arizona Arthritis and Rheumatology Research, PLLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85037
Country
United States
Facility Name
TriWest Research Associates, LLC
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
Valerius Medical Group and Research Center of Greater Long Beach, Inc
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Pacific Arthritis Center Medical Group
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Westlake Medical Research Inc.
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Inland Rheumatology and Osteoporosis Medical Group
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Arthritis Associates & Osteoporosis Center of Colorado Springs
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80920
Country
United States
Facility Name
Denver Arthritis Clinic
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Bay Area Arthritis and Osteoporosis
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Sunrise Research Institute, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33130
Country
United States
Facility Name
Omega Research Consultants, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Arthritis Center
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Arthritis Research of Florida, Inc.
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Southwest Florida Clinical Research Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Florida Medical Clinic, PA
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Idaho Arthritis and Osteoporosis Clinic
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Bluegrass Community Research, Inc.
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Arthritis and Rheumatology Consultants, P.A.
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
North Mississippi Medical Clinical, Inc
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Physician Research Collaboration, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Innovative Health Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Arthritis and Osteoporosis Consultants of The Carolinas
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Physicians East, PA
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
STAT Research Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Arthritis & Rheumatology Center of Oklahoma, PLLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Health Research of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Altoona Center For Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Emkey Arthritis and Osteoporosis Clinic, PC
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Low Country Rheumatology, PA
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Piedmont Arthritis Clinic, PA
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Amarillo Center for Clinical Research, Ltd.
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79124
Country
United States
Facility Name
Pioneer Research Solutions, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Arthritis and Osteoporosis Center of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78232
Country
United States
Facility Name
Rheumatic Disease Center
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53217
Country
United States
Facility Name
Praxis Prof. Herbert Kellner
City
München
State/Province
Bayern
ZIP/Postal Code
80639
Country
Germany
Facility Name
Praxiszentrum St. Bonifatius
City
München
State/Province
Bayern
ZIP/Postal Code
81541
Country
Germany
Facility Name
Rheumahaus - GbR
City
Potsdam
State/Province
Brandenburg
ZIP/Postal Code
14469
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60528
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. von Hinüber, Dr. Demary
City
Hildesheim
State/Province
Niedersachsen
ZIP/Postal Code
31134
Country
Germany
Facility Name
Klinikum Porz am Rhein
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
51149
Country
Germany
Facility Name
Schwerpunktpraxis Rheumatologie
City
Rendsburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
24768
Country
Germany
Facility Name
MVZ Ambulantes Rheumazentrum Erfurt
City
Erfurt
State/Province
Thüringen
ZIP/Postal Code
99096
Country
Germany
Facility Name
Rheumatology Center Prof. Neeck
City
Bad Doberan
ZIP/Postal Code
18209
Country
Germany
Facility Name
Rheumapraxis Steglitz
City
Berlin
ZIP/Postal Code
12161
Country
Germany
Facility Name
Immanuel Krankenhaus Berlin, Standort Berlin-Buch
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Rheumatologisches MVZ Dresden GmbH
City
Dresden
ZIP/Postal Code
01109
Country
Germany
Facility Name
Rheumatologie im Struensee-Haus
City
Hamburg
ZIP/Postal Code
22767
Country
Germany
Facility Name
LMU Klinikum der Universität München
City
München
ZIP/Postal Code
80336
Country
Germany
Facility Name
Studienambulanz Dr. Wassenberg
City
Ratingen
ZIP/Postal Code
40882
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Országos Reumatológiai És Fizioterápiás Intézet
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
QUALICLINIC Kft
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Csongrád Megyei Dr. Bugyi István Kórház
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
MÁV Kórház és Rendelőintézet Szolnok
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Twoja Przychodnia - Centrum Medyczne Nowa Sol
City
Nowa Sol
ZIP/Postal Code
67 -100
Country
Poland
Facility Name
Slaskie Centrum Reumatologii, Rehabilitacji i Zapobiegania Niepelnosprawnosci im gen. Jerzego Zietka
City
Ustron
ZIP/Postal Code
43-450
Country
Poland
Facility Name
Linea Corporis Chirurgia Plastyczna
City
Warszawa
ZIP/Postal Code
00-235
Country
Poland
Facility Name
Medycyna Kliniczna Marzena Waszczak
City
Warszawa
ZIP/Postal Code
00660
Country
Poland
Facility Name
Centrum Medyczne AMED
City
Warszawa
ZIP/Postal Code
01-518
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
30295429
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.
Results Reference
derived

Learn more about this trial

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

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