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

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.
 
ClinicalTrials.gov Identifier: NCT01217086
Recruitment Status : Completed
First Posted : October 8, 2010
Last Update Posted : March 12, 2013
Sponsor:
Information provided by (Responsible Party):
Celltrion

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Infliximab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 617 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Parallel-group, Phase 3 Study
Study Start Date : October 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis
Drug Information available for: Infliximab

Arms and Interventions
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Arm Intervention/treatment
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 Name: remicade
Active Comparator: Remicade Drug: Infliximab
Infliximab 3mg/kg is going to be administered for both arm as a 2-hour infusion per dose.
Other Name: remicade


Outcome Measures
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Primary Outcome Measures :
  1. PK equivalence to remicade [ Time Frame: PK sampling at week 30 ]

Secondary Outcome Measures :
  1. efficacy endpoint [ Time Frame: up to week 54. ]
    -ACR criteria comparison with Baseline at Weeks 14,30,54

  2. efficacy endpoint [ Time Frame: Up to week 54. ]
    - Time to onset of ACR20 response

  3. efficacy endpoint [ Time Frame: Up to week 54. ]
    - Mean decrease in disease activity measured by DAS28 comparison with Baseline at week 30

  4. efficacy endpoint [ Time Frame: Up to week 54. ]
    - Proportion of patients with a good response, defined according to the EULAR response criteria

  5. efficacy endpoint [ Time Frame: Up to week 54. ]
    - ACR20 at weeks 14 and 54

  6. efficacy endpoint [ Time Frame: Up to week 54. ]
    - ACR50 and ACR70 at weeks 14, 30, and 54

  7. efficacy endpoint [ Time Frame: Up to week 54. ]
    - Hybrid ACR response at weeks 14, 30, and 54

  8. efficacy endpoint [ Time Frame: Up to week 54. ]
    - SDAI and CDAI at weeks 14, 30, and 54

  9. efficacy endpoint [ Time Frame: Up to week 54. ]
    - Joint damage progression at week 54

  10. efficacy endpoint [ Time Frame: Up to week 54. ]
    - SF-36 at weeks 14, 30, and 54

  11. efficacy endpoint [ Time Frame: Up to week 54. ]
    - Fatigue

  12. efficacy endpoint [ Time Frame: Up to week 54. ]
    - Number of patients requiring salvage retreatment at weeks 30 and 54


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • have allergies to infliximab
  • serious infection
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01217086


Locations
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Korea, Republic of
Hanyang University Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Celltrion
Investigators
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Principal Investigator: Dae Hyun Yoo Hanyang University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT01217086    
Other Study ID Numbers: CT-P13 3.1
First Posted: October 8, 2010    Key Record Dates
Last Update Posted: March 12, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
 Immune System Diseases
Infliximab
Tumor Necrosis Factor Inhibitors
Anti-Inflammatory Agents
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents