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

Phase 4

• Conditions: Rheumatoid Arthritis of Knee
• Interventions: Drug: Intra-articular Tocilizumab; Drug: Intra-articular Compound Betamethasone

• Registration Number: NCT03215407
• Lead Sponsor: Chinese PLA General Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2017-06-22
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-12
• Last Update Submitted: 2017-07-12
• Last Update Posted: 2017-07-14
• Study Start: 2017-08-01
• Primary Completion: 2017-12-12
• Study Completion: 2018-03-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-articular Tocilizumab	Intra-articular Tocilizumab	Tocilizumab, solution, 80mg intra-articular.
Intra-articular Compound Betamethasone	Intra-articular Compound Betamethasone	Compound betamethasone, solution, 14mg intra-articular

Primary Outcome Measures

Name	Time	Method
change from OMERACT-EULAR composite PDUS synovitis score at 4 weeks	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 Outcome Measures

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