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MabThera®

DRUG8 trials

Sponsors

Boehringer Ingelheim, Pfizer, Archigen Biotech Limited, Biointegrator LLC, Dr. Reddy's Laboratories Limited

Conditions

Arthritis, RheumatoidCD20-positive Follicular Lymphoma, With Low Tumour BurdenFollicular LymphomaLymphoma, FollicularRheumatoid Arthritis

Phase 1

Safety, Tolerability, PK and PD of Biosimilar Drug Ritumax® Compared to Original Drug MabThera®
TerminatedNCT03061838
Biointegrator LLCRheumatoid Arthritis
Start: 2016-10-27End: 2018-03-14Updated: 2019-07-19
Study, Evaluating Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety Profiles of Rituximab Compared to MabThera® in Patients With Rheumatoid Arthritis
Active, not recruitingNCT06175338
Mabscale, LLCRheumatoid Arthritis
Start: 2023-06-14End: 2025-04-30Updated: 2024-09-19

Phase 3

Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis
TerminatedNCT01682512
Boehringer IngelheimArthritis, Rheumatoid
Start: 2012-09-05End: 2016-10-12Updated: 2018-01-30
A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06)
CompletedNCT02213263
PfizerFollicular Lymphoma
Start: 2014-09-30End: 2018-04-19Updated: 2019-06-20
A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy, Safety, and Immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Patients With Low Tumor Burden Follicular Lymphoma
CompletedNCT02809053
Archigen Biotech LimitedLymphoma, Follicular
Start: 2017-01-18End: 2020-01-10Updated: 2020-10-08
Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma
CompletedNCT03976102
Dr. Reddy's Laboratories LimitedFollicular Lymphoma
Start: 2019-05-15End: 2023-02-27Updated: 2024-01-22
Evaluate the Efficacy and Safety of HLX01 Versus Mabthera in Patients With Low Tumour Burden Follicular Lymphoma.
WithdrawnNCT04671420
Shanghai Henlius BiotechCD20-positive Follicular Lymphoma, With Low Tumour Burden
Start: 2020-10-31End: 2022-10-31Updated: 2020-12-17
MabionCD20® Compared to MabThera® and Rituxan® in Patients With Rheumatoid Arthritis
WithdrawnNCT04680962
Mabion SARheumatoid Arthritis
Start: 2023-08-03End: 2023-08-03Updated: 2023-08-07

Related Papers

Efficacy and safety of rituximab biosimilar (DRL_RI) versus MabThera <sup>®</sup> in low-tumor-burden follicular lymphoma: the FLINTER study
Therapeutic Advances in Medical Oncology2025-01-01
Efficacy and Safety of Rituximab Biosimilar (DRL_RI) Versus Mabthera in Low Tumor Burden Follicular Lymphoma: The Flinter Study
Blood2024-11-05
Factors Influencing Infusion-Related Reactions Following Dosing of Reference Rituximab and PF-05280586, a Rituximab Biosimilar.
2021-06-219 citations
Factors influencing infusion-related reactions following dosing of reference rituximab (RTX) and PF-05280586, a RTX biosimilar.
Journal of Clinical Oncology2020-05-20
A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera&lt;sup&gt;®&lt;/sup&gt;) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL).
2020-04-0131 citations
A Randomized, Double-Blind Efficacy and Safety Study of PF-05280586 (a Potential Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera®) in Subjects with Previously Untreated CD20-Positive, Low Tumor Burden Follicular Lymphoma (LTB-FL)
Blood2018-11-297 citations