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Completed

NCT Number: NCT01217086

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hanyang University Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • have allergies to infliximab
  • serious infection

Treatment and study plan

Infliximab

Drug

Infliximab 3mg/kg is going to be administered for both arm as a 2-hour infusion per dose.

Other names: remicade

Primary outcomes

  1. PK equivalence to remicade

    Time frame: PK sampling at week 30

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study title

Randomized, Double-blind, Parallel-group, Phase 3 Study

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Oct 8, 2010
Registry last updated
Mar 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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