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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Celltrion

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Infliximab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014