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

Overview

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.

Full Title of Study: “The Comparative Study of Safety and Effectiveness of Intra-articular Injection of Tocilizumab and Compound Betamethasone in Rheumatoid Arthritis of the Knee”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: December 12, 2017

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.

Interventions

  • 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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • change from OMERACT-EULAR composite PDUS synovitis score at 4 weeks
    • Time Frame: 0 and 4 weeks
    • use articular ultrasound to explore the condition of knee and evaluate the condition of knee by OMERACT-EULAR composite PDUS synovitis score

Secondary Measures

  • change from disease activity score at 4 weeks
    • Time Frame: 0 and 4 weeks
    • DAS28-CRP, DAS28-ESR
  • change from Health Assessment Questionnaire at 4 weeks
    • Time Frame: 0 and 4 weeks
    • HAQ
  • change from Rheumatoid and arthritis outcome score at 4 weeks
    • Time Frame: 0 and 4 weeks
    • RAOS
  • change from composite change index at 4 weeks
    • Time Frame: 0 and 4 weeks
    • CCI score
  • change from diameter of knee joint at 4 weeks
    • Time Frame: 0 and 4 weeks
    • diameter of knee joint
  • change from knee flexion range at 4 weeks
    • Time Frame: 0 and 4 weeks
    • knee flexion range

Participating in This Clinical Trial

Inclusion Criteria

1. Age range: 18-65 years

2. Patients must be diagnosed as rheumatoid arthritis according to the 2010 ACR classification diagnostic criteria for RA for at least 6 months.

3. Patients' knee is swelling or has effusion.

4. Patients have used the same dosage of DMARDs or biologics for at least 6 weeks and continue using the drug until the end of the study.

5. If patients are using glucocorticoid or NSAIDs, the dosage must be stabilized for at least 4 weeks and continue until the end of the study.

6. Patients must understand the aim and steps of this study, can come back for follow-up timely.

Exclusion Criteria

1. Patients' knee is out of shape. X-ray shows a moderate or severe damage of subchondral bone, or joint space is less than 3 mm.

2. Patients have received intra-articular injection of glucocorticoid or TNFi, joint replacement, or synovectomy.

3. Patients is suffering from other autoimmune diseases or Spondyloarthritis.

4. The skin of knee is damaged severely.

5. Patients is suffering from pulmonary tuberculosis, or Chest X-ray shows lesion signs related to tuberculosis.

6. For the last 3 months, patients have participated in other new drug's clinical trial.

7. Other patients who have been thought not suitable for the study by researchers.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese PLA General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jian Zhu, Associated Prof. of Medicine, Deputy Director of Rheumatology – Chinese PLA General Hospital

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