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

May 20, 2015 updated by: Celltrion

Phase 1, Randomized, Controlled, Multicenter, 2-Arm, Parallel-Group, Double-Blind Study to Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient has a diagnosis of RA according to the revised 1987 ACR classification criteria (Arnett et al 1987) for at least 6 months prior to randomization.
  2. Patient has active disease as defined by the presence of 6 or more swollen joints (of 66 assessed) and 6 or more tender joints (of 68 assessed), and serum CRP ≥1.5 mg/dL or an ESR ≥28 mm/hour.

Exclusion Criteria:

  1. Patient is unresponsive or intolerable to more than 2 biologic agents.
  2. Patient has allergies or hypersensitivity to murine, chimeric, human, or humanized proteins.
  3. Patient has current or past history of chronic infection with hepatitis B, hepatitis C, or infection with human immunodeficiency virus (HIV)-1 or -2 or who has a positive result to the screening test for these infections.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: MabThera
rituximab
Biological: rituximab
1000 mg by intravenous (IV) infusion. Each patient may receive 2 courses of treatment.
ACTIVE_COMPARATOR: CT-P10
rituximab
Biological: rituximab
1000 mg by intravenous (IV) infusion. Each patient may receive 2 courses of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK in terms of Cmax
Time Frame: Up to Week 24
maximum serum concentration
Up to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celltrion

Investigators

  • Study Director: DaeHyun Yoo, M.D., Ph.D., Hanyang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

August 1, 2013

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

February 8, 2012

First Submitted That Met QC Criteria

February 14, 2012

First Posted (ESTIMATE)

February 17, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 22, 2015

Last Update Submitted That Met QC Criteria

May 20, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-P10 1.1
  • 2011-002822-37 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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