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

November 30, 2017 updated by: Sandoz

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®

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Doberan, Germany, 18209
        • Rheumatology Center Prof. Neeck
      • Berlin, Germany, 12161
        • Rheumapraxis Steglitz
      • Berlin, Germany, 13125
        • Immanuel Krankenhaus Berlin, Standort Berlin-Buch
      • Dresden, Germany, 01109
        • Rheumatologisches MVZ Dresden GmbH
      • Hamburg, Germany, 22767
        • Rheumatologie im Struensee-Haus
      • München, Germany, 80336
        • LMU Klinikum der Universität München
      • Ratingen, Germany, 40882
        • Studienambulanz Dr. Wassenberg
      • Würzburg, Germany, 97080
        • Universitatsklinikum Wurzburg
    • Bayern
      • München, Bayern, Germany, 80639
        • Praxis Prof. Herbert Kellner
      • München, Bayern, Germany, 81541
        • Praxiszentrum St. Bonifatius
    • Brandenburg
      • Potsdam, Brandenburg, Germany, 14469
        • Rheumahaus - GbR
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60528
        • Universitätsklinikum Frankfurt
    • Niedersachsen
      • Hildesheim, Niedersachsen, Germany, 31134
        • Gemeinschaftspraxis Dr. von Hinüber, Dr. Demary
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 51149
        • Klinikum Porz am Rhein
    • Schleswig-Holstein
      • Rendsburg, Schleswig-Holstein, Germany, 24768
        • Schwerpunktpraxis Rheumatologie
    • Thüringen
      • Erfurt, Thüringen, Germany, 99096
        • MVZ Ambulantes Rheumazentrum Erfurt
  • Hungary
      • Budapest, Hungary, 1023
        • Orszagos Reumatologiai es Fizioterapias Intezet
      • Budapest, Hungary, 1036
        • Qualiclinic Kft
      • Szentes, Hungary, 6600
        • Csongrád Megyei Dr. Bugyi István Kórház
      • Szolnok, Hungary, 5000
        • MAV Korhaz es Rendelointezet Szolnok
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
      • Nowa Sol, Poland, 67 -100
        • Twoja Przychodnia - Centrum Medyczne Nowa Sol
      • Ustron, Poland, 43-450
        • Slaskie Centrum Reumatologii, Rehabilitacji i Zapobiegania Niepelnosprawnosci im gen. Jerzego Zietka
      • Warszawa, Poland, 01-518
        • Centrum Medyczne AMED
      • Warszawa, Poland, 00-235
        • Linea Corporis Chirurgia Plastyczna
      • Warszawa, Poland, 00660
        • Medycyna Kliniczna Marzena Waszczak
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Rheumatology Associates of North Alabama, PC
      • Tuscaloosa, Alabama, United States, 35406
        • Clinical and Translational Research Center of Alabama PC
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Arizona Arthritis & Rheumatology Research, PLLC
      • Mesa, Arizona, United States, 85202
        • Arizona Arthritis and Rheumatology Research, PLLC
      • Phoenix, Arizona, United States, 85037
        • Arizona Arthritis and Rheumatology Research, PLLC
      • Phoenix, Arizona, United States, 85032
        • Arizona Arthritis & Rheumatology Research, PLLC
    • California
      • El Cajon, California, United States, 92020
        • TriWest Research Associates, LLC
      • Long Beach, California, United States, 90806
        • Valerius Medical Group and Research Center of Greater Long Beach, Inc
      • Santa Maria, California, United States, 93454
        • Pacific Arthritis Center Medical Group
      • Thousand Oaks, California, United States, 91360
        • Westlake Medical Research Inc.
      • Upland, California, United States, 91786
        • Inland Rheumatology and Osteoporosis Medical Group
    • Colorado
      • Colorado Springs, Colorado, United States, 80920
        • Arthritis Associates & Osteoporosis Center of Colorado Springs
      • Denver, Colorado, United States, 80230
        • Denver Arthritis Clinic
    • Florida
      • Brandon, Florida, United States, 33511
        • Bay Area Arthritis and Osteoporosis
      • Miami, Florida, United States, 33130
        • Sunrise Research Institute, Inc.
      • Orlando, Florida, United States, 32804
        • Omega Research Consultants, LLC
      • Palm Harbor, Florida, United States, 34684
        • Arthritis Research Of Florida, Inc.
      • Palm Harbor, Florida, United States, 34684
        • Arthritis Center
      • Tampa, Florida, United States, 33609
        • Southwest Florida Clinical Research Center
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic, PA
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Idaho Arthritis and Osteoporosis Clinic
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Bluegrass Community Research, Inc.
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Arthritis and Rheumatology Consultants, P.A.
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • North Mississippi Medical Clinical, Inc
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Physician Research Collaboration, LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Innovative Health Research
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Arthritis and Osteoporosis Consultants of the Carolinas
      • Greenville, North Carolina, United States, 27834
        • Physicians East, PA
    • Ohio
      • Dayton, Ohio, United States, 45417
        • Stat Research Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Health Research of Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Arthritis & Rheumatology Center of Oklahoma, PLLC
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
      • Wyomissing, Pennsylvania, United States, 19610
        • Emkey Arthritis and Osteoporosis Clinic, PC
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Low Country Rheumatology, PA
      • Greenville, South Carolina, United States, 29601
        • Piedmont Arthritis Clinic, PA
    • Texas
      • Amarillo, Texas, United States, 79124
        • Amarillo Center for Clinical Research, Ltd.
      • Houston, Texas, United States, 77099
        • Pioneer Research Solutions, Inc.
      • San Antonio, Texas, United States, 78232
        • Arthritis and Osteoporosis Center of South Texas
    • Wisconsin
      • Glendale, Wisconsin, United States, 53217
        • Rheumatic Disease Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GP2013 - 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).
Biological: GP2013 - A Proposed biosimilar rituximab
Active Comparator: 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).
Biological: Originator rituximab - Rituxan ® or MabThera ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Experiencing Anaphylactic Reactions
Time Frame: 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 Network
Within 24 hours of each study drug infusion: on Day 1 and Day 14
Number of Patients Experiencing Hypersensitivity Reactions
Time Frame: 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.
24 weeks study duration
Immunogenicity
Time Frame: 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
24 weeks study duration
Number of Patients Experiencing Potential Infusion-Related Reactions
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandoz

Collaborators

Hexal AG

Investigators

  • Study Chair: Sandoz Inc., Sponsor GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

July 30, 2015

First Submitted That Met QC Criteria

July 31, 2015

First Posted (Estimate)

August 4, 2015

Study Record Updates

Last Update Posted (Actual)

December 28, 2017

Last Update Submitted That Met QC Criteria

November 30, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GP13-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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