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Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis

NCT01534884 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2015-05-22

No results posted yet for this study

Summary

This randomized,controlled, multicenter, 2-arm, parallel-group, double-blind, prospective, Phase 1 study is designed to demonstrate comparable pharmacokinetics in terms of AUC0-last and Cmax (after second infusion) between CT-P10 and MabThera in patients with active RA concomitantly treated with MTX during the Core Study Period.

Conditions

Interventions

BIOLOGICAL

rituximab

1000 mg by intravenous (IV) infusion. Each patient may receive 2 courses of treatment.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-08-31
Completion
2014-02-28

Countries

  • South Korea

Study Locations

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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 NCT01534884 on ClinicalTrials.gov