Rheumatoid Arthritis of Knee Clinical Trial
Official title:
The Comparative Study of Safety and Effectiveness of Intra-articular Injection of Tocilizumab and Compound Betamethasone in Rheumatoid Arthritis of the Knee
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.
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