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Open-label, Extension Study of CDP870 in Patients With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Certolizumab Pegol
Sponsored by
Korea Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Failed to achieve an ACR20 response at Week 12 in the Study 101-KOA-0801i or completed the entire Study 101-KOA-0801i through Week 24
  • Have a clear chest X-ray at the Entry visit
  • Negative urine pregnancy test at the Entry
  • Continue treatment on methotrexate

Exclusion Criteria:

  • Any other inflammatory arthritis (e.g., psoriatic arthritis, ankylosing spondylitis or reactive arthritis)
  • Secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
  • At study entry taking any of the prohibited medications as detailed in the Study (Protocol) # 101-KOA-0801i
  • NYHA (New York Heart Association) Class III or IV congestive heart failure
  • Current or history of tuberculosis
  • History of chronic infection, recent serious or life-threatening infection or any current sign or symptom that may indicate an infection (e.g., fever, cough)
  • History of a lymphoproliferative disorder including lymphoma or signs and symptoms suggesting lymphoproliferative disease
  • High risk of infection
  • Female breast feeding, pregnant or plan to become pregnant during the trial or for 12 weeks following the last dose of study drug

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Certolizumab Pegol

    Arm Description

    Single Arm

    Outcomes

    Primary Outcome Measures

    To assess the safety of CZP for a long term period as additional medication to MTX, in patients with active RA, as measured by adverse events frequency, severity and nature; PE and vitals; and laboratory values, blood parameters and urine parameters.
    Treatment will continue until the drug is commercially available in the country.

    Secondary Outcome Measures

    To assess the clinical response rate measured by ACR20, ACR50 and ACR70 responder rate.
    Treatment will continue until the drug is commercially available in the country.
    Improvement in patient's Health-Related Quality of Life (HRQOL) as measured by the 36-item Short Form Health Survey (SF-36)
    Treatment will continue until the drug is commercially available in the country.
    To assess the achievement of clinical remission measured by DAS28.
    Treatment will continue until the drug is commercially available in the country.
    The improvement in physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI).
    Treatment will continue until the drug is commercially available in the country.

    Full Information

    First Posted
    March 17, 2010
    Last Updated
    June 7, 2022
    Sponsor
    Korea Otsuka Pharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01197066
    Brief Title
    Open-label, Extension Study of CDP870 in Patients With Rheumatoid Arthritis
    Official Title
    A Phase Ⅲ Multicenter, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Certolizumab Pegol as Additional Medication to Methotrexate, in Patients With Active Rheumatoid Arthritis Who Participated in Study 101-KOA-0801i
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2010 (Actual)
    Primary Completion Date
    November 2016 (Actual)
    Study Completion Date
    November 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Korea Otsuka Pharmaceutical Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a phase Ⅲ multicenter, open-label, follow-up study, to assess the safety and efficacy of certolizumab pegol (CZP) as additional medication to methotrexate (MTX), in patients with active rheumatoid arthritis (RA) who participated in Study (Protocol) # 101-KOA-0801i.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    110 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Certolizumab Pegol
    Arm Type
    Other
    Arm Description
    Single Arm
    Intervention Type
    Drug
    Intervention Name(s)
    Certolizumab Pegol
    Other Intervention Name(s)
    CDP870, CIMZIA, Perstymab
    Intervention Description
    Certolizumab Pegol 200mg
    Primary Outcome Measure Information:
    Title
    To assess the safety of CZP for a long term period as additional medication to MTX, in patients with active RA, as measured by adverse events frequency, severity and nature; PE and vitals; and laboratory values, blood parameters and urine parameters.
    Description
    Treatment will continue until the drug is commercially available in the country.
    Time Frame
    Up to 7 years
    Secondary Outcome Measure Information:
    Title
    To assess the clinical response rate measured by ACR20, ACR50 and ACR70 responder rate.
    Description
    Treatment will continue until the drug is commercially available in the country.
    Time Frame
    Up to 7 years
    Title
    Improvement in patient's Health-Related Quality of Life (HRQOL) as measured by the 36-item Short Form Health Survey (SF-36)
    Description
    Treatment will continue until the drug is commercially available in the country.
    Time Frame
    Up to 7 years
    Title
    To assess the achievement of clinical remission measured by DAS28.
    Description
    Treatment will continue until the drug is commercially available in the country.
    Time Frame
    Up to 7 years
    Title
    The improvement in physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI).
    Description
    Treatment will continue until the drug is commercially available in the country.
    Time Frame
    Up to 7 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Failed to achieve an ACR20 response at Week 12 in the Study 101-KOA-0801i or completed the entire Study 101-KOA-0801i through Week 24 Have a clear chest X-ray at the Entry visit Negative urine pregnancy test at the Entry Continue treatment on methotrexate Exclusion Criteria: Any other inflammatory arthritis (e.g., psoriatic arthritis, ankylosing spondylitis or reactive arthritis) Secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia) At study entry taking any of the prohibited medications as detailed in the Study (Protocol) # 101-KOA-0801i NYHA (New York Heart Association) Class III or IV congestive heart failure Current or history of tuberculosis History of chronic infection, recent serious or life-threatening infection or any current sign or symptom that may indicate an infection (e.g., fever, cough) History of a lymphoproliferative disorder including lymphoma or signs and symptoms suggesting lymphoproliferative disease High risk of infection Female breast feeding, pregnant or plan to become pregnant during the trial or for 12 weeks following the last dose of study drug
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    YoungMo Kang, MD, PhD
    Organizational Affiliation
    Kyungpook National University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Open-label, Extension Study of CDP870 in Patients With Rheumatoid Arthritis

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