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A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products

NCT04268771 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-11-18

Study results available
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Summary

The objective of the current study is to assess the immunogenicity and safety of transitioning subjects with RA to DRL\_RI from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab.

The primary objective of this study is to assess the immunogenicity of transitioning subjects with RA to DRL\_RI (biosimilar rituximab) from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab

To assess the safety of transitioning subjects with RA to DRL\_RI from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab.

Conditions

Interventions

BIOLOGICAL

Experimental: Arm A: DRL_RI

Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion

BIOLOGICAL

Arm B: Rituxan®/Mabthera®

Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-08
Primary Completion
2022-01-26
Completion
2022-04-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04268771 on ClinicalTrials.gov