Long-Term Efficacy and Safety of CT-P10 in Patients With RA

November 25, 2015 updated by: Celltrion

An Open-Label, Single-Arm, Maintenance Study to Demonstrate Long-Term Efficacy and Safety of CT-P10 in Patients With Rheumatoid Arthritis Who Were Treated With Rituximab (MabThera or CT-P10) in Study CT-P10 1.1

This is an open-label, single-arm, multicenter, efficacy, and safety maintenance study of the Phase 1 Study CT-P10 1.1. This study is designed to assess the long-term efficacy and safety of CT-P10 co-administered with MTX and folic acid in patients with RA who have completed the scheduled visits in Study CT-P10 1.1

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

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

  • Korea, Republic of
      • Incheon, Korea, Republic of
        • Inha University College of Medicine Hospital

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:

  • Patient has disease improvement (moderate or good response) according to Disease Activity Score using 28 joint counts (DAS28) during the last course of treatment in Study CT-P10 1.1.
  • Patient has completed all of the scheduled visits in the Study CT-P10 1.1 Main Study Period, including the Core Study Period and/or Extension Study Period.

Exclusion Criteria:

  • Patient has been withdrawn from Study CT-P10 1.1 for any reason.
  • Patient has, at the time of providing informed consent, any current medical issues such as serious adverse events (SAEs) or current or previous intolerance issues that mean continuation in this maintenance study could be detrimental to their health, in the opinion of the investigator.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rituximab, MTX, folic acid
Drug: Rituximab, MTX, folic acid
Rituximab IV 1000mg MTX 10~25mg/week Folic acid at least 5mg/week
Other Names:
  • Rituximab=CT-P10

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy evaluation by ACR criteria and safety evaluation by hypersensitivity monitoring
Time Frame: 8 week interval
Efficacy will be assessed by evaluation of ACR criteria (ACR 20% , ACR 50% , ACR 70%, and hybrid ACR response), Safety will be assessed by evaluation of hypersensitivity monitoring via vital sign measurements (including blood pressure, heart and respiratory rates, and body temperature),etc,.
8 week interval

Collaborators and Investigators

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

Sponsor

Celltrion

Investigators

  • Study Director: DaeHyun Yoo, 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

May 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

May 22, 2013

First Submitted That Met QC Criteria

June 6, 2013

First Posted (Estimate)

June 10, 2013

Study Record Updates

Last Update Posted (Estimate)

November 26, 2015

Last Update Submitted That Met QC Criteria

November 25, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-P10 1.3
  • 2012-005502-21 (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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