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MabionCD20® Compared to MabThera® and Rituxan® in Patients With Rheumatoid Arthritis

NCT04680962 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2023-08-07

No results posted yet for this study

Summary

Primary objective of the study is to establish a 3-way PK similarity bridge between MabionCD20 (candidate biosimilar to rituximab), MabThera® (EU-sourced rituximab) and Rituxan® (US-sourced rituximab) following the administration of these drugs to patients with moderate-to-severe rheumatoid arthritis. Main secondary objective is to confirm therapeutic similarity between MabionCD20 and the reference rituximab.

Conditions

Interventions

BIOLOGICAL

MabionCD20 (candidate biosimilar to rituximab)

Intravenous infusion, 10 mg/ml concentrate, 500 ml

BIOLOGICAL

MabThera®

Intravenous infusion, 10 mg/ml concentrate, 500 ml

BIOLOGICAL

Rituxan®

Intravenous infusion, 10 mg/ml concentrate, 500 ml

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Mabion SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-03
Primary Completion
2023-08-03
Completion
2023-08-03
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04680962 on ClinicalTrials.gov