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

NCT ID: NCT03215407

Last Updated: 2017-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2018-03-03

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.

Conditions

Rheumatoid Arthritis of Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intra-articular Tocilizumab

Tocilizumab, solution, 80mg intra-articular.

Group Type: EXPERIMENTAL

Intra-articular Tocilizumab

Intervention Type: DRUG

Patients will be randomly chosen to be intra-articular injected of tocilizumab injection

Intra-articular Compound Betamethasone

Compound betamethasone, solution, 14mg intra-articular

Group Type: ACTIVE_COMPARATOR

Intra-articular Compound Betamethasone

Intervention Type: DRUG

Patients will be randomly chosen to be intra-articular injected of compound betamethasone injection

Interventions

Intra-articular Tocilizumab

Patients will be randomly chosen to be intra-articular injected of tocilizumab injection

Intervention Type: DRUG

Intra-articular Compound Betamethasone

Patients will be randomly chosen to be intra-articular injected of compound betamethasone injection

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jian Zhu

Associated Prof. of Medicine, Deputy Director of Rheumatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ChinaPLAGH(Intraarticular+TCZ)

Identifier Type: -

Identifier Source: org_study_id