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Rituxan

Rituxan

Drug

Drug Profile

Rituxan (rituximab) is a CD20-directed cytolytic monoclonal antibody used in hematologic malignancies and selected autoimmune conditions. Labeling lists indications including non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis (with methotrexate), and granulomatosis with polyangiitis/microscopic polyangiitis (with glucocorticoids). U.S. initial approval was in 1997.

Drug Class: CD20-directed cytolytic monoclonal antibody
Approval Status: FDA approved (Initial U.S. Approval: 1997)
Mechanism of Action: Targets CD20 on pre-B and mature B lymphocytes and mediates B-cell lysis via CDC and ADCC.

Brand Names

RITUXAN

Indications

\Non-Hodgkin's lymphoma\
\Chronic lymphocytic leukemia\
\Rheumatoid arthritis in combination with methotrexate after inadequate response to TNF antagonists\
\Granulomatosis with polyangiitis and microscopic polyangiitis in combination with glucocorticoids\

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Related Clinical Trials

NCT ID	Title	Status	Phase
NCT06790420	RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer] Post-marketing Database Study	COMPLETED
NCT04323748	Dose Dense Rituximab for High Risk Newly Diagnosed Acute Immune Thrombocytopenic Purpura	RECRUITING	PHASE1
NCT03531736	T Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Conditioned With a Reduced Intensity Regimen in Patients With Hematologic Malignancies and Aplastic Anemia	ACTIVE_NOT_RECRUITING	PHASE1
NCT02819726	PK, PD, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis	COMPLETED	PHASE1
NCT02296775	Comparative Pharmacokinetic, Pharmacodynamic, Safety and Efficacy Study of Three Anti-CD20 Monoclonal Antibodies in Patients With Moderate to Severe Rheumatoid Arthritis	COMPLETED	PHASE1/PHASE2
NCT02282514	Stem Cell Transplantation for Stiff Person Syndrome (SPS)	TERMINATED	PHASE1/PHASE2
NCT02260804	To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma	COMPLETED	PHASE3
NCT02240407	Re-administration of Intramuscular AAV9 in Patients With Late-Onset Pompe Disease	COMPLETED	PHASE1
NCT02162771	To Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan	COMPLETED	PHASE3
NCT02149121	PK Similarity Prospective Phase 3 Study in Patients With Rheumatoid Arthritis	COMPLETED	PHASE3