We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01217086
First Posted: October 8, 2010
Last Update Posted: March 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Celltrion
October 4, 2010
October 8, 2010
March 12, 2013
October 2010
November 2011   (Final data collection date for primary outcome measure)
PK equivalence to remicade [ Time Frame: PK sampling at week 30 ]
Same as current
Complete list of historical versions of study NCT01217086 on ClinicalTrials.gov Archive Site
  • efficacy endpoint [ Time Frame: up to week 54. ]
    -ACR criteria comparison with Baseline at Weeks 14,30,54
  • efficacy endpoint [ Time Frame: Up to week 54. ]
    - Time to onset of ACR20 response
  • efficacy endpoint [ Time Frame: Up to week 54. ]
    - Mean decrease in disease activity measured by DAS28 comparison with Baseline at week 30
  • efficacy endpoint [ Time Frame: Up to week 54. ]
    - Proportion of patients with a good response, defined according to the EULAR response criteria
  • efficacy endpoint [ Time Frame: Up to week 54. ]
    - ACR20 at weeks 14 and 54
  • efficacy endpoint [ Time Frame: Up to week 54. ]
    - ACR50 and ACR70 at weeks 14, 30, and 54
  • efficacy endpoint [ Time Frame: Up to week 54. ]
    - Hybrid ACR response at weeks 14, 30, and 54
  • efficacy endpoint [ Time Frame: Up to week 54. ]
    - SDAI and CDAI at weeks 14, 30, and 54
  • efficacy endpoint [ Time Frame: Up to week 54. ]
    - Joint damage progression at week 54
  • efficacy endpoint [ Time Frame: Up to week 54. ]
    - SF-36 at weeks 14, 30, and 54
  • efficacy endpoint [ Time Frame: Up to week 54. ]
    - Fatigue
  • efficacy endpoint [ Time Frame: Up to week 54. ]
    - Number of patients requiring salvage retreatment at weeks 30 and 54
efficacy endpoint [ Time Frame: Up to week 54. ]
Not Provided
Not Provided
 
Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in RA Patients(PLANETRA)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: Infliximab
Infliximab 3mg/kg is going to be administered for both arm as a 2-hour infusion per dose.
Other Name: remicade
  • Active Comparator: CT-P13
    Intervention: Drug: Infliximab
  • Active Comparator: Remicade
    Intervention: Drug: Infliximab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
617
July 2012
November 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • have allergies to infliximab
  • serious infection
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01217086
CT-P13 3.1
Yes
Not Provided
Not Provided
Celltrion
Celltrion
Not Provided
Principal Investigator: Dae Hyun Yoo Hanyang University
Celltrion
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP