Multicenter, Open-Label, Phase IV Study to Evaluate the Safety,Tolerability, and Efficacy of Tocilizumab in Patients with Active Rheumatoid arthritis on background non-biologic DMARDs who have an inadequate response to current non-biologic DMARD and/or Anti- TNF therapy
Phase 4
- Conditions
- Rheumatoid Arthritis.Seropositive Rheumatoid Arthritis
- Registration Number
- IRCT201008312641N3
- Lead Sponsor
- Akbarieh Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Inclusion Criteria: age more than 18 years, moderate to severe rheumatoid arthritis (DAS28 >3.2) of 6 months duration, inadequate clinical response to non-biologic DMARDs or anti-TNF, body weight less than150 kg
Exclusion Criteria
rheumatic autoimmune disease or inflammatory joint disease other than RA, major surgery within 8 weeks prior to screening or planned major surgery within 6 months following screening
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Strokes. Timepoint: Each Visit. Method of measurement: Physical Examination ,BP,EKG.;Liver transaminase level. Timepoint: Each visit. Method of measurement: Liver Alkaline Phosphatase ,ALT ,AST.;Lipid Level. Timepoint: Each visit. Method of measurement: Lipid Profile.;Neutrophil count. Timepoint: Each visit. Method of measurement: CBC/dif.;To assess the safety. Timepoint: Each visit. Method of measurement: AEs happend within 24 weeks of treatment.;Infusion Reaction. Timepoint: Each visit. Method of measurement: An Infusion Reaction is defined as an AE occurring within 24 hours following the infusion.;Major adverse cardiac event. Timepoint: Each visit. Method of measurement: Physical Examination,BP,EKG.
- Secondary Outcome Measures
Name Time Method Severity of Disease. Timepoint: Each visit. Method of measurement: DAS Score.