Rheumatoid ArthritisPhase 3ASSIST-RTNCT02514772
GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®
A Phase 3 study testing GP2013 - A Proposed biosimilar rituximab and Originator rituximab - Rituxan ® or MabThera ® in people with Rheumatoid Arthritis, run by Sandoz at 65 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- GP2013 - A Proposed biosimilar rituximab and Originator rituximab - Rituxan ® or MabThera ®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 65 sitesin 4 countries
- Study dates
- Jul 2015to Oct 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
65 sites in 4 countries.
65 sites in 4 countries
United States39 sites
Amarillo Center for Clinical Research, Ltd.
Amarillo, Texas, 79124
Bay Area Arthritis and Osteoporosis
Brandon, Florida, 33511
Low Country Rheumatology, PA
Charleston, South Carolina, 29406
Arthritis and Osteoporosis Consultants of The Carolinas
Charlotte, North Carolina, 28207
Arthritis Associates & Osteoporosis Center of Colorado Springs
Colorado Springs, Colorado, 80920
STAT Research Inc.
Dayton, Ohio, 45417
Denver Arthritis Clinic
Denver, Colorado, 80230
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635
Arthritis and Rheumatology Consultants, P.A.
Edina, Minnesota, 55435
TriWest Research Associates, LLC
El Cajon, California, 92020
Arizona Arthritis & Rheumatology Research, PLLC
Glendale, Arizona, 85306
Rheumatic Disease Center
Glendale, Wisconsin, 53217
Physicians East, PA
Greenville, North Carolina, 27834
Piedmont Arthritis Clinic, PA
Greenville, South Carolina, 29601
Pioneer Research Solutions, Inc.
Houston, Texas, 77099
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, 35801
Innovative Health Research
Las Vegas, Nevada, 89128
Bluegrass Community Research, Inc.
Lexington, Kentucky, 40504
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516
Valerius Medical Group and Research Center of Greater Long Beach, Inc
Long Beach, California, 90806
Idaho Arthritis and Osteoporosis Clinic
Meridian, Idaho, 83642
Arizona Arthritis and Rheumatology Research, PLLC
Mesa, Arizona, 85202
Sunrise Research Institute, Inc.
Miami, Florida, 33130
Arthritis & Rheumatology Center of Oklahoma, PLLC
Oklahoma City, Oklahoma, 73103
Health Research of Oklahoma
Oklahoma City, Oklahoma, 73103
Omega Research Consultants, LLC
Orlando, Florida, 32804
Arthritis Center
Palm Harbor, Florida, 34684
Arthritis Research of Florida, Inc.
Palm Harbor, Florida, 34684
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, 85032
Arizona Arthritis and Rheumatology Research, PLLC
Phoenix, Arizona, 85037
Arthritis and Osteoporosis Center of South Texas
San Antonio, Texas, 78232
Pacific Arthritis Center Medical Group
Santa Maria, California, 93454
Southwest Florida Clinical Research Center
Tampa, Florida, 33609
Westlake Medical Research Inc.
Thousand Oaks, California, 91360
North Mississippi Medical Clinical, Inc
Tupelo, Mississippi, 38801
Clinical and Translational Research Center of Alabama PC
Tuscaloosa, Alabama, 35406
Inland Rheumatology and Osteoporosis Medical Group
Upland, California, 91786
Emkey Arthritis and Osteoporosis Clinic, PC
Wyomissing, Pennsylvania, 19610
Florida Medical Clinic, PA
Zephyrhills, Florida, 33542
Germany16 sites
Rheumatology Center Prof. Neeck
Bad Doberan, 18209
Rheumapraxis Steglitz
Berlin, 12161
Immanuel Krankenhaus Berlin, Standort Berlin-Buch
Berlin, 13125
Klinikum Porz am Rhein
Cologne, North Rhine-Westphalia, 51149
Rheumatologisches MVZ Dresden GmbH
Dresden, 01109
MVZ Ambulantes Rheumazentrum Erfurt
Erfurt, Thuringia, 99096
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, 60528
Rheumatologie im Struensee-Haus
Hamburg, 22767
Gemeinschaftspraxis Dr. von Hinüber, Dr. Demary
Hildesheim, Lower Saxony, 31134
Praxis Prof. Herbert Kellner
München, Bavaria, 80639
Praxiszentrum St. Bonifatius
München, Bavaria, 81541
LMU Klinikum der Universität München
München, 80336
Rheumahaus - GbR
Potsdam, Brandenburg, 14469
Studienambulanz Dr. Wassenberg
Ratingen, 40882
Schwerpunktpraxis Rheumatologie
Rendsburg, Schleswig-Holstein, 24768
Universitätsklinikum Würzburg
Würzburg, 97080
Poland6 sites
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, 67 -100
Slaskie Centrum Reumatologii, Rehabilitacji i Zapobiegania Niepelnosprawnosci im gen. Jerzego Zietka
Ustroń, 43-450
Linea Corporis Chirurgia Plastyczna
Warsaw, 00-235
Medycyna Kliniczna Marzena Waszczak
Warsaw, 00660
Centrum Medyczne AMED
Warsaw, 01-518
Hungary4 sites
Országos Reumatológiai És Fizioterápiás Intézet
Budapest, 1023
QUALICLINIC Kft
Budapest, 1036
Csongrád Megyei Dr. Bugyi István Kórház
Szentes, 6600
MÁV Kórház és Rendelőintézet Szolnok
Szolnok, 5000
About this study
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®
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- GP2013 - A Proposed biosimilar rituximab, Originator rituximab - Rituxan ® or MabThera ®
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP2013 - A Proposed biosimilar rituximabBiological
Originator rituximab - Rituxan ® or MabThera ®Biological
| Study group | Role | What they receive |
|---|---|---|
| GP2013 - proposed biosimilar rituximab | Experimental | 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). Receives: Biological: GP2013 - A Proposed biosimilar rituximab |
| Originator rituximab - Rituxan ® or MabThera ® | Active comparator | 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). Receives: Biological: Originator rituximab - Rituxan ® or MabThera ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hexal AG
- Responsible party
- Sponsor
- Investigators
- Sandoz Inc., Study chair, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514772
- Sponsor's protocol ID
- GP13-302
- Acronym
- ASSIST-RT
- Status last verified
- Nov 2017
- First submitted
- 30 Jul 2015
- Last updated
- 28 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 30295429
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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®
- ClinicalTrials.gov ID
- NCT02514772
- Acronym / sponsor ID
- ASSIST-RT / GP13-302
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Collaborators
- Hexal AG
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 4 Aug 2015 (estimated)
- Results
- Posted 28 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GP2013 - proposed biosimilar rituximab | Experimental | Biological: GP2013 - A Proposed biosimilar rituximab10 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 comparator | Biological: 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GP2013 - A Proposed biosimilar rituximab | Biological | GP2013 - proposed biosimilar rituximab |
| Originator rituximab - Rituxan ® or MabThera ® | Biological | Originator rituximab - Rituxan ® or MabThera ® |
Primary outcome
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
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.
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30295429Tony 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandoz Inc. study chair
Sponsor GmbH
65 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GP2013 - A Proposed biosimilar rituximab and Originator rituximab - Rituxan ® or MabThera ® in people with Rheumatoid Arthritis, run by Sandoz at 65 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, Germany, Poland, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Experiencing Anaphylactic Reactions (time frame: Within 24 hours of each study drug infusion: on Day 1 and Day 14). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02514772, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2017.