Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in AS Patients(PLANETAS)

March 11, 2013 updated by: Celltrion

Randomized, Double-blind, Parallel-group, Phase 1 Study

This study is the trial to demonstrate how our product is similar to remicade by comparing the results of blood samples in active Ankylosing Spondylitis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

257

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:

  • diagnosed with active ankylosing spondylitis
  • BASDAI score ≥ 4 and visual analogue scale(VAS) score of spinal pain ≥ 4

Exclusion Criteria:

  • have total ankylosing of spine
  • 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: CT-P13
infliximab
Drug: Infliximab
Infliximab 5mg/kg is going to be administered for both arm as a 2-hour infusion per dose.
Active Comparator: Remicade
infliximab
Drug: Infliximab
Infliximab 5mg/kg is going to be administered for both arm as a 2-hour infusion per dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PK equivalence to remicade
Time Frame: PK sampling at week 22
PK sampling at week 22

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 20% criteria
Time Frame: at week 14, 30 and 54
at week 14, 30 and 54
Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 40 criteria
Time Frame: at week 14, 30 and 54
at week 14, 30 and 54
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 14, 30 and 54 compared with Baseline
Time Frame: at week 14, 30 and 54
at week 14, 30 and 54
Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 14, 30 and 54 compared with Baseline
Time Frame: at week 14, 30 and 54
at week 14, 30 and 54
Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 30 and 54 compared with Baseline
Time Frame: at weeks 14, 30 and 54
at weeks 14, 30 and 54
Chest expansion at Weeks 14, 30 and 54 compared with Baseline
Time Frame: at weeks 14, 30 and 54
at weeks 14, 30 and 54
Quality of life questionnaire (SF-36)
Time Frame: at week 14, 30 and 54
at week 14, 30 and 54

Collaborators and Investigators

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

Sponsor

Celltrion

Investigators

  • Principal Investigator: Won Park, M.D., Ph.D., Inha University Hospital

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)

June 1, 2012

Study Registration Dates

First Submitted

October 4, 2010

First Submitted That Met QC Criteria

October 12, 2010

First Posted (Estimate)

October 14, 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 1.1

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.

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