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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celltrion
ClinicalTrials.gov Identifier:
NCT01217086
First received: October 4, 2010
Last updated: March 11, 2013
Last verified: March 2013

October 4, 2010
March 11, 2013
October 2010
November 2011   (final data collection date for primary outcome measure)
PK equivalence to remicade [ Time Frame: PK sampling at week 30 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01217086 on ClinicalTrials.gov Archive Site
  • efficacy endpoint [ Time Frame: up to week 54. ] [ Designated as safety issue: No ]
    -ACR criteria comparison with Baseline at Weeks 14,30,54
  • efficacy endpoint [ Time Frame: Up to week 54. ] [ Designated as safety issue: No ]
    - Time to onset of ACR20 response
  • efficacy endpoint [ Time Frame: Up to week 54. ] [ Designated as safety issue: No ]
    - Mean decrease in disease activity measured by DAS28 comparison with Baseline at week 30
  • efficacy endpoint [ Time Frame: Up to week 54. ] [ Designated as safety issue: No ]
    - Proportion of patients with a good response, defined according to the EULAR response criteria
  • efficacy endpoint [ Time Frame: Up to week 54. ] [ Designated as safety issue: No ]
    - ACR20 at weeks 14 and 54
  • efficacy endpoint [ Time Frame: Up to week 54. ] [ Designated as safety issue: No ]
    - ACR50 and ACR70 at weeks 14, 30, and 54
  • efficacy endpoint [ Time Frame: Up to week 54. ] [ Designated as safety issue: No ]
    - Hybrid ACR response at weeks 14, 30, and 54
  • efficacy endpoint [ Time Frame: Up to week 54. ] [ Designated as safety issue: No ]
    - SDAI and CDAI at weeks 14, 30, and 54
  • efficacy endpoint [ Time Frame: Up to week 54. ] [ Designated as safety issue: No ]
    - Joint damage progression at week 54
  • efficacy endpoint [ Time Frame: Up to week 54. ] [ Designated as safety issue: No ]
    - SF-36 at weeks 14, 30, and 54
  • efficacy endpoint [ Time Frame: Up to week 54. ] [ Designated as safety issue: No ]
    - Fatigue
  • efficacy endpoint [ Time Frame: Up to week 54. ] [ Designated as safety issue: No ]
    - Number of patients requiring salvage retreatment at weeks 30 and 54
efficacy endpoint [ Time Frame: up to week 54. ] [ Designated as safety issue: No ]
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 Blind (Subject, 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
Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, Kovalenko V, Prodanovic N, Abello-Banfi M, Gutierrez-Ureña S, Morales-Olazabal L, Tee M, Jimenez R, Zamani O, Lee SJ, Kim H, Park W, Müller-Ladner U. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013 Oct;72(10):1613-20. doi: 10.1136/annrheumdis-2012-203090. Epub 2013 May 16.

*   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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01217086
CT-P13 3.1
Yes
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