Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in RA Patients(PLANETRA)

March 11, 2013 updated by: Celltrion

Randomized, Double-blind, Parallel-group, Phase 3 Study

This is the trial to see how our product is similar to remicade by comparing the results of blood samples when co-administered with methotrexate between 12.5 to 25 mg/week, oral or parenteral dose and folic acid in rheumatoid arthritis patients who are not receiving adequate response to methotrexate alone up to week 30.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

617

Phase

  • Phase 3

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:

  • diagnosed with active rheumatoid arthritis
  • at least 3 months of treatment with methotrexate

Exclusion Criteria:

  • have allergies to infliximab
  • serious infection

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Remicade
Drug: Infliximab
Infliximab 3mg/kg is going to be administered for both arm as a 2-hour infusion per dose.
Other Names:
  • remicade
Active Comparator: CT-P13
Drug: Infliximab
Infliximab 3mg/kg is going to be administered for both arm as a 2-hour infusion per dose.
Other Names:
  • remicade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PK equivalence to remicade
Time Frame: PK sampling at week 30
PK sampling at week 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy endpoint
Time Frame: up to week 54.
-ACR criteria comparison with Baseline at Weeks 14,30,54
up to week 54.
efficacy endpoint
Time Frame: Up to week 54.
- Time to onset of ACR20 response
Up to week 54.
efficacy endpoint
Time Frame: Up to week 54.
- Mean decrease in disease activity measured by DAS28 comparison with Baseline at week 30
Up to week 54.
efficacy endpoint
Time Frame: Up to week 54.
- Proportion of patients with a good response, defined according to the EULAR response criteria
Up to week 54.
efficacy endpoint
Time Frame: Up to week 54.
- ACR20 at weeks 14 and 54
Up to week 54.
efficacy endpoint
Time Frame: Up to week 54.
- ACR50 and ACR70 at weeks 14, 30, and 54
Up to week 54.
efficacy endpoint
Time Frame: Up to week 54.
- Hybrid ACR response at weeks 14, 30, and 54
Up to week 54.
efficacy endpoint
Time Frame: Up to week 54.
- SDAI and CDAI at weeks 14, 30, and 54
Up to week 54.
efficacy endpoint
Time Frame: Up to week 54.
- Joint damage progression at week 54
Up to week 54.
efficacy endpoint
Time Frame: Up to week 54.
- SF-36 at weeks 14, 30, and 54
Up to week 54.
efficacy endpoint
Time Frame: Up to week 54.
- Fatigue
Up to week 54.
efficacy endpoint
Time Frame: Up to week 54.
- Number of patients requiring salvage retreatment at weeks 30 and 54
Up to week 54.

Collaborators and Investigators

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

Sponsor

Celltrion

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

October 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

October 4, 2010

First Submitted That Met QC Criteria

October 7, 2010

First Posted (Estimate)

October 8, 2010

Study Record Updates

Last Update Posted (Estimate)

March 12, 2013

Last Update Submitted That Met QC Criteria

March 11, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-P13 3.1

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.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Infliximab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe