The objective of this trial is to compare the efficacy of Certolizumab (CZP) (CDP870) in combination with Methotrexate (MTX) to MTX alone in the treatment of signs and symptoms in patients with active rheumatoid arthritis (RA) who are incomplete responders to MTX.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
127
Given every 2 weeks until Week22 (SC)
400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week 22(SC)
Received treatment with Methotrexate(MTX)for at least 24 weeks prior to the Baseline Visit. The dose and route of administration of MTX had to have been stable for at least 8 weeks prior to the Baseline Visit. The minimum stable dose of MTX allowed is 10mg weekly.
Kyungpook National University Hospital
Daegu, South Korea
Catholic University Hospital of Daegu
Daegu, South Korea
Eulji University Hospital
Daejeon, South Korea
ACR20 Responses at Week 24
Achieving ACR20 means 20% or greater improvement in the number of tender joints, a 20% or more improvement in the number of swollen joints and a 20% or greater improvement in at least three of the five remaining core set measures: Patient's and physician's global assessments, Patient's assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.
Time frame: Week 24
ACR 20 Responses at Week 12
Achieving ACR20 means 20% or greater improvement in the number of tender joints, a 20% or more improvement in the number of swollen joints and a 20% or greater improvement in at least three of the five remaining core set measures: Patient's and physician's global assessments, Patient's assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.
Time frame: Week 12
ACR50 Responses at Week 12
Achieving ACR50 means 50% or greater improvement in the number of tender joints, a 50% or more improvement in the number of swollen joints and a 50% or greater improvement in at least three of the five remaining core set measures: Patient's and physician's global assessments, Patient's assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.
Time frame: Week 12
ACR70 Responses at Week 12
Achieving ACR70 means 70% or greater improvement in the number of tender joints, a 70% or more improvement in the number of swollen joints and a 70% or greater improvement in at least three of the five remaining core set measures: Patient's and physician's global assessments, Patient's assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.
Time frame: Week12
ACR50 Responses at Week 24
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Inha University Hospital
Inchon, South Korea
Chonnam National University Hospital
Kwangju, South Korea
Pusan National University Hospital
Pusan, South Korea
Yonsei University Severance Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Catholic University of Korea ST.Mary's Hospital
Seoul, South Korea
...and 5 more locations
Time frame: Week 24
ACR70 Responses at Week24
Time frame: Week 24
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Range of HAQ-DI score: 0-3 This outcome measures changes of HAQ-DI score at Week 24 from Baseline. Lower score of HAQ-DI represents a better outcome.
Time frame: Baseline and Week 24