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
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
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
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
NCT ID
NCT01197066
First Posted
March 17, 2010
Last Updated
June 7, 2022
Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
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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