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CURRENT CLINICAL TRIALS

CLINICAL TRIALS CONDUCTED CURRENTLY BY MABION SA

 

MabionCD20-001RA

MabionCD20-002NHL

Objective of the Trial

Demonstrating the biosimilarity between MabionCD20 and MabThera (rituximab, Roche)

Therapeutic Area

Diffuse Large B-cell Lymphoma (DLBCL)

Rheumatoid Arthritis

Trial type and phase

Therapeutic confirmatory (Phase 3)

Scope of the Trial

Safety, Efficacy, Pharmacokinetic, Pharmacodynamic, Bioequivalence

Design of the Trial

Randomized, Double-blind, Parallel group

Number of countries involved in clinical operations

6

10

Number of sites involved in clinical operations

52

48

Number of patients required by Study protocol to complete the Study

624

112

Number of patients to be randomized according to Study protocol

734

140

Number of patients to be screened according to Study protocol

863

175

 

 

 

 

 

 

 

 

 

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