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

Conditions

• Rheumatoid Arthritis of Knee

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Aug 1, 2017

Status verified

Jul 2017

Primary completion

Dec 12, 2017

Completion

Mar 3, 2018

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Intra-articular Tocilizumab
  Tocilizumab, solution, 80mg intra-articular.
• Active Comparator: Intra-articular Compound Betamethasone
  Compound betamethasone, solution, 14mg intra-articular

Primary Outcome Measure

change from OMERACT-EULAR composite PDUS synovitis score at 4 weeks [ Time Frame: 0 and 4 weeks ]