{"id":"rituximab-pfizer","rwe":[],"tags":[],"phase":"preclinical","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"active","trials":["NCT02925338","NCT00867087","NCT03975790","NCT01307267","NCT01232556","NCT00562965","NCT01679119","NCT02213263","NCT01055496","NCT01170052","NCT01078142","NCT04951323","NCT01526057","NCT02663518","NCT03530683","NCT00299494","NCT05487703","NCT05099471","NCT06790420","NCT02951156","NCT03636503","NCT04404283","NCT01134575","NCT01562990","NCT00868608"],"aliases":[],"patents":[],"pricing":[],"allNames":"rituximab pfizer","offLabel":[],"timeline":[{"date":"2011","type":"negative","milestone":"Phase 3 Initiated","description":"Phase 3 trial (Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Ch) — Lymphoma, Follicular. Trial terminated early."},{"date":"2012","type":"neutral","milestone":"Phase 2 Initiated","description":"Phase 2 trial (Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma) — Lymphoma"},{"date":"2013","type":"neutral","milestone":"Phase 1 Initiated","description":"Phase 1 trial (Study Evaluating Chemotherapy in Combination With Inotuzumab Ozogamicin In Subjects With Non-Hodgkin) — Lymphoma, B-Cell"}],"aiSummary":"Rituximab Pfizer, also known as PF-05280586, is a binding agent that targets the B-lymphocyte antigen CD20. It is used to treat conditions such as Rheumatoid Arthritis, Follicular Lymphoma, and Lymphoma.","brandName":"Rituximab Pfizer","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"Monoclonal antibody","drugClass":"For the acute therapy, Rituximab is administrated once a week up to 8 times and for maintenance ther","explanation":"Rituximab Pfizer works by targeting a specific protein called CD20 that appears on the surface of B cells—a type of white blood cell involved in producing antibodies and fighting infection. By binding to this CD20 protein, rituximab acts like a label or flag, essentially marking these B cells for destruction. The immune system then recognizes these marked cells and eliminates them through several mechanisms, including direct killing and antibody-dependent cell killing.\n\nIn cancer, this approach is beneficial because B-cell lymphomas and leukemias represent abnormal, dangerous versions of B cells that multiply uncontrollably. By removing these malignant cells, rituximab helps shrink tumors and improve survival. In autoimmune diseases like rheumatoid arthritis, the benefit comes from reducing autoreactive B cells that are mistakenly attacking the body's own tissues, which decreases inflammation and joint damage.\n\nRituximab Pfizer is a biosimilar, meaning it's manufactured through a different biological process than the original rituximab but is designed to work identically. This provides patients with the same therapeutic benefits while offering potential cost advantages. The drug is administered intravenously and works gradually over weeks, with effects that can last for months after treatment completion.","oneSentence":"For the acute therapy, Rituximab is administrated once a week up to 8 times and for maintenance ther","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"genericName":"rituximab-pfizer","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Lymphoma","phase":"preclinical","trialId":"","patients":null,"diseaseId":"oncology","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT02925338","phase":"N/A","title":"National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":1431,"indication":"Crohn Disease","completionDate":"2021-04","primaryEndpoint":"National, prospective, multicentre observational study designed for eligible patients treated with Inflectra."},{"nctId":"NCT00867087","phase":"Phase 2","title":"Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin'","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":64,"indication":"Lymphoma, B-Cell","completionDate":"2012-10","primaryEndpoint":"The purpose of this study is to evaluate inotuzumab ozogamicin in combination with rituximab prior to an autologous stem cell transplant (aSCT) in patients with relapsed/refractory diffuse large B-cel"},{"nctId":"NCT03975790","phase":"N/A","title":"Comparative Analysis of Outcomes Among Patients Initiating Xeljanz in Combination With Oral MTX Who ","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":479,"indication":"Rheumatoid Arthritis","completionDate":"2018-10","primaryEndpoint":"To address the objectives, a retrospective cohort design will be employed to evaluate patient characteristics, treatment patterns, medication effectiveness, and health care cost and utilization in RA "},{"nctId":"NCT01307267","phase":"Phase 1","title":"A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":190,"indication":"Lymphoma, Non-Hodgkin","completionDate":"2019-02","primaryEndpoint":"A study of PF-05082566, a 4-1BB agonist monoclonal antibody (mAb), in patients with solid tumors or b-cell lymphomas, and in combination with rituximab in patients with CD20 positive Non-Hodgkin's Lym"},{"nctId":"NCT01232556","phase":"Phase 3","title":"A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymph","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":338,"indication":"Lymphoma, Non-Hodgkin","completionDate":"2014-03","primaryEndpoint":"The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin plus rituximab in relapsed/refractory aggressive Non-Hodgkin lymphoma patients who are not candidates for intensive high-"},{"nctId":"NCT00562965","phase":"Phase 3","title":"Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Ch","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":29,"indication":"Lymphoma, Follicular","completionDate":"2011-04","primaryEndpoint":"This protocol is designed to assess the efficacy and safety of inotuzumab ozogamicin given with rituximab compared to a defined investigator's choice therapy."},{"nctId":"NCT01679119","phase":"Phase 2","title":"Treatment of Patients With Diffuse Large B Cell Lymphoma Who Are Not Suitable for Anthracycline Cont","status":"Completed","sponsor":"University College, London","isPivotal":false,"enrollment":129,"indication":"Diffuse Large B Cell Lymphoma","completionDate":"2019-03","primaryEndpoint":"The purpose of this trial is to compare the efficacy and safety of Inotuzumab Ozogamicin in combination with R-CVP with that of R-G-CVP for the treatment of Diffuse Large B Cell Lymphoma (DLBCL) in a "},{"nctId":"NCT02213263","phase":"Phase 3","title":"A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment O","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":394,"indication":"Follicular Lymphoma","completionDate":"2017-10","primaryEndpoint":"This study will compare the safety and effectiveness of PF-05280586 versus rituximab-EU in patients with CD20-positive, low tumor burden follicular lymphoma."},{"nctId":"NCT01055496","phase":"Phase 1","title":"Study Evaluating Chemotherapy in Combination With Inotuzumab Ozogamicin In Subjects With Non-Hodgkin","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":103,"indication":"Lymphoma, B-Cell","completionDate":"2013-07","primaryEndpoint":"This is a phase 1 trial designed to evaluate safety and tolerability of chemotherapy in combination with inotuzumab ozogamicin, an investigational product, in adults with CD22-positive non-Hodgkin's l"},{"nctId":"NCT01170052","phase":"Phase 1/2","title":"Bendamustine and Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Non-Hodgkin's Lymp","status":"Withdrawn","sponsor":"Charite University, Berlin, Germany","isPivotal":false,"enrollment":20,"indication":"Mantle Cell Lymphoma","completionDate":"2012-04","primaryEndpoint":"The purpose of this study is to assess the safety, tolerability and activity of the combination of bendamustine and rituximab in patients with relapsed/refractory mantle cell lymphoma who are not elig"},{"nctId":"NCT01078142","phase":"Phase 1/2","title":"Temsirolimus, Bendamustine and Rituximab for Relapsed Follicular Lymphoma or Mantle Cell Lymphoma","status":"Completed","sponsor":"Georg Hess, MD","isPivotal":false,"enrollment":39,"indication":"Follicular Lymphoma","completionDate":"2017-09","primaryEndpoint":"This is a multicenter, open label, single arm, phase I/II study."},{"nctId":"NCT04951323","phase":"Phase 3","title":"Impact of the Immune System on Response to Anti-Coronavirus Disease 19 (COVID-19) Vaccine in Allogen","status":"Unknown","sponsor":"University of Liege","isPivotal":false,"enrollment":50,"indication":"Coronavirus Disease 2019 (Covid19)","completionDate":"2022-12","primaryEndpoint":"The present study is a prospective phase IV study."},{"nctId":"NCT01526057","phase":"Phase 2","title":"A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active R","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":220,"indication":"Rheumatoid Arthritis","completionDate":"2013-08","primaryEndpoint":"In this study, patients with moderate to severe rheumatoid arthritis who are being treated with methotrexate will receive 2 intravenous treatments with either PF-05280586 or Rituxan (Rituximab) or Mab"},{"nctId":"NCT02663518","phase":"Phase 1","title":"A Trial of PF-07901800 (TTI-621) for Patients With Hematologic Malignancies and Selected Solid Tumor","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":249,"indication":"Hematologic Malignancies","completionDate":"2022-11","primaryEndpoint":"Multicenter, open-label, phase 1a/1b trial of PF-07901800 (TTI-621) in subjects with relapsed or refractory hematologic malignancies and selected solid tumors."},{"nctId":"NCT03530683","phase":"Phase 1","title":"A Clinical Trial to Learn About the Study Medicine Called Maplirpacept (PF-07901801), Alone and When","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":189,"indication":"Lymphoma","completionDate":"2024-07","primaryEndpoint":"The purpose of this clinical trial is to learn how the experimental medicine maplirpacept (PF-07901801) affects people with various types of blood cancers: * relapsed or refractory (R/R) lymphoma * mu"},{"nctId":"NCT00299494","phase":"Phase 1/2","title":"Study Evaluating Inotuzumab Ozogamicin [CMC-544] Administered In Combination With Rituximab In Subje","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":119,"indication":"B-Cell Lymphoma","completionDate":"2014-05","primaryEndpoint":"The purpose of the study is to determine the tolerability, the initial safety profile and maximum tolerated dose, and to obtain preliminary information on the antitumor activity of inotuzumab ozogamic"},{"nctId":"NCT05487703","phase":"N/A","title":"A Study To Describe The Use Of Tofacitinib After Use Of Rituximab In Patients With Rheumatoid Arthri","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":318,"indication":"Arthritis, Rheumatoid","completionDate":"2022-12","primaryEndpoint":"This study is to characterize the use of tofacitinib after use of rituximab in patients with Rheumatoid Arthritis in a real-world setting."},{"nctId":"NCT05099471","phase":"Phase 2","title":"Efficacy of Venetoclax in Combination With Rituximab in Waldenström's Macroglobulinemia","status":"Recruiting","sponsor":"Christian Buske","isPivotal":false,"enrollment":80,"indication":"Waldenstrom Macroglobulinemia","completionDate":"2028-03","primaryEndpoint":"In Waldenström's macroglobulinemia (WM) chemotherapy induces only low CR/VGPR rates and response duration is limited."},{"nctId":"NCT06790420","phase":"N/A","title":"RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer] Post-marketing Database Study","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":1,"indication":"Lymphoma","completionDate":"2025-03","primaryEndpoint":"To evaluate the incidence of the outcomes for the safety specifications in patients of Medical Data Vision database in Japan diagnosed with CD20 positive B-cell non- Hodgkin's lymphoma who were treate"},{"nctId":"NCT02951156","phase":"Phase 3","title":"Avelumab In Combination Regimens That Include An Immune Agonist, Epigenetic Modulator, CD20 Antagoni","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":29,"indication":"Diffuse Large B-Cell Lymphoma","completionDate":"2019-12","primaryEndpoint":"Study B9991011 is a multi-center, international, randomized, open label, 2 component (Phase 1b followed by Phase 3), parallel-arm study of avelumab in combination with various agents for the treatment"},{"nctId":"NCT03636503","phase":"Phase 1","title":"Rituximab + Immunotherapy in Follicular Lymphoma","status":"Terminated","sponsor":"Dana-Farber Cancer Institute","isPivotal":false,"enrollment":24,"indication":"Follicular Lymphoma","completionDate":"2021-07","primaryEndpoint":"This research study is studying several new investigational drug combinations as a possible treatment for follicular lymphoma."},{"nctId":"NCT04404283","phase":"Phase 3","title":"Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL","status":"Active Not Recruiting","sponsor":"Seagen, a wholly owned subsidiary of Pfizer","isPivotal":false,"enrollment":238,"indication":"Diffuse Large B-cell Lymphoma","completionDate":"2026-12","primaryEndpoint":"Participants in this study will have diffuse large B-cell lymphoma (DLBCL) that has come back or not gotten better with treatment."},{"nctId":"NCT01134575","phase":"Phase 2","title":"CMC-544 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL)","status":"Completed","sponsor":"M.D. Anderson Cancer Center","isPivotal":false,"enrollment":90,"indication":"Acute Lymphoblastic Leukemia","completionDate":"2018-04","primaryEndpoint":"The goal of this clinical research study is to learn if CMC-544 given alone, and possibly given in combination with rituximab, can help to control the disease in patients with ALL."},{"nctId":"NCT01562990","phase":"Phase 1/2","title":"Phase Ib/II Study of the Efficacy and Safety of the R-CMC544/R-GEMOX Combination in Diffuse Lage B-c","status":"Completed","sponsor":"The Lymphoma Academic Research Organisation","isPivotal":false,"enrollment":11,"indication":"Diffuse Large B-Cell Lymphoma","completionDate":"2014-08","primaryEndpoint":"The purpose of this study is to determine the recommended dose of CMC544 administered in combination with rituximab (R-CMC544), and in alternance with rituximab, gemcitabine and oxaliplatin (R-GEMOX) "},{"nctId":"NCT00868608","phase":"Phase 2","title":"Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":81,"indication":"Lymphoma","completionDate":"2012-01","primaryEndpoint":"The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin (CMC-544) in subjects with indolent Non-Hodgkins lymphoma (NHL) that is refractory or has relapsed after multiple 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