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PK Similarity Prospective Phase 3 Study in Patients With Rheumatoid Arthritis

NCT02149121 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2021-12-16

Study results available
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Summary

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis.

Conditions

Interventions

BIOLOGICAL

CT-P10

1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion

DRUG

Rituxan

US-licensed reference product, 1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion

DRUG

MabThera

EU-approved reference product, 1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion

Sponsors & Collaborators

Principal Investigators

  • DaeHyun Yoo, M.D., Ph.D · Hanyang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-01-31
Completion
2017-01-31
FDA Drug
Yes

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Entities

Drugs
Diseases
Companies

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 NCT02149121 on ClinicalTrials.gov