Anti-TNF-Study Utilizing Biomarker Assay to Monitor Early Response to Certolizumab Pegol
Not Applicable
- Conditions
- Rheumatoid Arthritis
- Registration Number
- JPRN-UMIN000022831
- Lead Sponsor
- niversity of Occupational and Environmental Health, Japan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
Patients were excluded if they had history of demyelinating or convulsive disease of the central nervous system (e.g., multiple sclerosis and epilepsy), New York Heart Association Class III or IV congestive heart failure, infectious disease, hepatitis B or hepatitis C, malignant tumor or lymphoproliferative disorder, including lymphoma or signs and symptoms suggestive of lymphoproliferative disease. Patients with any indication of current or past tuberculosis as shown by clinical history, chest X-ray and/or positive tuberculin reaction test were also excluded unless preventive therapy by isoniazid was first taken.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of DAS28-ESR at 12weeks
- Secondary Outcome Measures
Name Time Method (1)Change of DAS28-ESR at 24 hours, 48hours and 24weeks (2)Remission rate of DAS28 and CDAI at 24 hours, 48hours, 12 weeks and 24weeks (3) Adverse event (4) The factors for each outcomes