Aim: Comparing the efficacy and safety of intra-articular injection of tocilizumab and compound betamethasone. Study design: A randomized, single-blind, parallel controlled and one center trial design. Sample size: 60 cases. Study content: Patients who meet inclusive criteria will be randomly divided into tocilizumab group and compound betamethasone group. In the baseline period, the investigators will collect patients' general information, disease information, disease activity score, laboratory results and images of articular ultrasound. After 4 weeks of injection, patients will be asked to come back, and their disease information, disease activity score, laboratory results as well as images of articular ultrasound will be collected. Finally, these data will be sorted and analyzed. Hypothesis: The efficacy and safety of intra-articular injection of tocilizumab is better than that of compound betamethasone.
Aim: Comparing the efficacy and safety of intra-articular injection of tocilizumab and compound betamethasone. Study design: A randomized, single-blind, parallel controlled and one center trial design, the study period is 4 weeks. Sample size: 60 cases. Study content: Patients who meet inclusive criteria will be randomly divided into tocilizumab group and compound betamethasone group according to the random number table. In the baseline period, the investigators will collect patients' general information, disease information, disease activity score, laboratory results and images of articular ultrasound. After 4 weeks of injection, patients will be asked to come back, and their disease information, disease activity score, laboratory results as well as images of articular ultrasound will be collected. Finally, these data will be sorted and analyzed. Index of effect evaluation: 1) Articular ultrasound, OMERACT-EULAR composite PDUS synovitis score will be used to evaluate the condition of articulation; 2) Disease activity score, DAS28-CRP, DAS28-ESR; 3) Health Assessment Questionnaire, HAQ; 4) Rheumatoid and arthritis outcome score, RAOS; 5) composite change index, CCI score; 6) diameter of knee joint; 7) knee flexion range. Hypothesis: The efficacy and safety of intra-articular injection of tocilizumab is better than that of compound betamethasone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Patients will be randomly chosen to be intra-articular injected of tocilizumab injection
Patients will be randomly chosen to be intra-articular injected of compound betamethasone injection
change from OMERACT-EULAR composite PDUS synovitis score at 4 weeks
use articular ultrasound to explore the condition of knee and evaluate the condition of knee by OMERACT-EULAR composite PDUS synovitis score
Time frame: 0 and 4 weeks
change from disease activity score at 4 weeks
DAS28-CRP, DAS28-ESR
Time frame: 0 and 4 weeks
change from Health Assessment Questionnaire at 4 weeks
HAQ
Time frame: 0 and 4 weeks
change from Rheumatoid and arthritis outcome score at 4 weeks
RAOS
Time frame: 0 and 4 weeks
change from composite change index at 4 weeks
CCI score
Time frame: 0 and 4 weeks
change from diameter of knee joint at 4 weeks
diameter of knee joint
Time frame: 0 and 4 weeks
change from knee flexion range at 4 weeks
knee flexion range
Time frame: 0 and 4 weeks
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