NCT03215407

The Comparative Study of Intra-articular Injection of Tocilizumab and Compound Betamethasone

The Comparative Study of Safety and Effectiveness of Intra-articular Injection of Tocilizumab and Compound Betamethasone in Rheumatoid Arthritis of the Knee

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Rheumatoid Arthritis of Knee

Interventions

Type	Name	Description
DRUG	Intra-articular Tocilizumab	Patients will be randomly chosen to be intra-articular injected of tocilizumab injection
DRUG	Intra-articular Compound Betamethasone	Patients will be randomly chosen to be intra-articular injected of compound betamethasone injection

Timeline

• Start date: 2017-08-01
• Primary completion: 2017-12-12
• Completion: 2018-03-03
• First posted: 2017-07-12
• Last updated: 2017-07-14