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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
History of Changes
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
 Drug: Infliximab
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Parallel-group, Phase 3 Study

Resource links provided by NLM:

Drug Information available for: Infliximab
U.S. FDA Resources

Further study details as provided by Celltrion:

Primary Outcome Measures:
  • PK equivalence to remicade [ Time Frame: PK sampling at week 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Enrollment: 617
Study Start Date: October 2010
Study Completion Date: July 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01217086

Locations
Korea, Republic of
Hanyang University Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Celltrion
Investigators
Principal Investigator: Dae Hyun Yoo Hanyang University
  More Information

No publications provided

Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT01217086     History of Changes
Other Study ID Numbers: CT-P13 3.1
Study First Received: October 4, 2010
Last Updated: March 11, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Immune System Diseases
 Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 21, 2013