A Study of CDP870 as Add-on Meditation to Methotrexate (MTX) in Patients With Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Interventions
- Registration Number
- NCT00993317
- Lead Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
- Adult-onset RA of at least 6 months but not longer than 15 years in duration as defined by the 1987 American College of Rheumatology classification criteria
- Active RA disease as defined by at least 9 tender joints and 9 swollen joints, ESR of 30 mm/hour or CRP of 1.5 mg/dL
- MTX (with or without folic acid) for at least 24 weeks prior to the Baseline visit, The dose of MTX and route of administration must have been stable for at least 8 weeks prior to the baseline visit. The minimum stable dose of MTX allowed is 10 mg weekly.
- Any other inflammatory arthritis (e.g., psoriatic arthritis, ankylosing spondylitis or reactive arthritis)
- Secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
- 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 (within 24 weeks , including herpes zoster), or any current sign or symptom that may indicate an infection (e.g., fever, cough)
- High risk of infection
- Have received any experimental non-biological therapy, within or outside a clinical trial in the 12 weeks prior to Baseline
- Have received previous B-cell therapy (eg. Rituximab)
- Have received any other biological therapy for RA within 24 weeks prior to Baseline visit, except for etanercept where a three month washout prior to baseline visit is acceptable
- Have received previous treatment with a biological therapy for RA that resulted in a severe hypersensitivity reaction or an anaphylactic reaction
- Failed to respond to previous treatment with an anti-TNF drug
- Female breast feeding, pregnant or plan to become pregnant during the trial or for 12 weeks following the last dose of study drug
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo of CDP870+MTX Placebo of CDP870 - CDP870 200mg+MTX CDP870 200mg - Placebo of CDP870+MTX Methotrexate - CDP870 200mg+MTX Methotrexate -
- Primary Outcome Measures
Name Time Method ACR20 Responses at Week 24 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.
- Secondary Outcome Measures
Name Time Method ACR 20 Responses at Week 12 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.
ACR50 Responses at Week 12 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.
ACR70 Responses at Week 12 Week12 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.
ACR50 Responses at Week 24 Week 24 ACR70 Responses at Week24 Week 24 Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Baseline and Week 24 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.
Trial Locations
- Locations (15)
Seoul national univeristy
🇰🇷Seoul, Korea, Republic of
Catholic University of Korea ST.Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Catholic University Hospital of Daegu
🇰🇷Daegu, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang Universoty Hospital
🇰🇷Seoul, Korea, Republic of
Eulji University Hospital
🇰🇷Daejeon, Korea, Republic of
Yonsei University Severance Hospital
🇰🇷Seoul, Korea, Republic of
KonKuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Inha University Hospital
🇰🇷Inchon, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Chonnam National University Hospital
🇰🇷Kwangju, Korea, Republic of