Rheumatoid Arthritis Clinical Trial
— ASSIST-RTOfficial 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®
Verified date | November 2017 |
Source | Sandoz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Sandoz | Hexal AG |
United States, Germany, Hungary, Poland,
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) |
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