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

NCT03215407 | Unknown Phase 4

• 1 other identifier: ChinaPLAGH(Intraarticular+TCZ)
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis of Knee

Outcome Measures

Primary Outcomes (1)

• change from OMERACT-EULAR composite PDUS synovitis score at 4 weeks

  use articular ultrasound to explore the condition of knee and evaluate the condition of knee by OMERACT-EULAR composite PDUS synovitis score

  0 and 4 weeks

Secondary Outcomes (6)

• change from disease activity score at 4 weeks

  0 and 4 weeks

• change from Health Assessment Questionnaire at 4 weeks

  0 and 4 weeks

• change from Rheumatoid and arthritis outcome score at 4 weeks

  0 and 4 weeks

• change from composite change index at 4 weeks

  0 and 4 weeks

• change from diameter of knee joint at 4 weeks

  0 and 4 weeks

Study Arms (2)

Intra-articular Tocilizumab

EXPERIMENTAL

Tocilizumab, solution, 80mg intra-articular.

Drug: Intra-articular Tocilizumab

Intra-articular Compound Betamethasone

ACTIVE COMPARATOR

Compound betamethasone, solution, 14mg intra-articular

Drug: Intra-articular Compound Betamethasone

Interventions

Intra-articular Tocilizumab DRUG

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

Intra-articular Tocilizumab

Intra-articular Compound Betamethasone DRUG

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

Intra-articular Compound Betamethasone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range: 18-65 years
• Patients must be diagnosed as rheumatoid arthritis according to the 2010 ACR classification diagnostic criteria for RA for at least 6 months.
• Patients' knee is swelling or has effusion.
• 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.
• 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.
• Patients must understand the aim and steps of this study, can come back for follow-up timely.

You may not qualify if:

• 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.
• Patients have received intra-articular injection of glucocorticoid or TNFi, joint replacement, or synovectomy.
• Patients is suffering from other autoimmune diseases or Spondyloarthritis.
• The skin of knee is damaged severely.
• Patients is suffering from pulmonary tuberculosis, or Chest X-ray shows lesion signs related to tuberculosis.
• For the last 3 months, patients have participated in other new drug's clinical trial.
• Other patients who have been thought not suitable for the study by researchers.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

MeSH Terms

Interventions

tocilizumab

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Prof. of Medicine, Deputy Director of Rheumatology

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: July 12, 2017
• Study Start: August 1, 2017
• Primary Completion: December 12, 2017
• Study Completion: March 3, 2018
• Last Updated: July 14, 2017

Record last verified: 2017-07