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

The Comparative Study of Safety and Effectiveness of Intra-articular Injection of Tocilizumab and Compound Betamethasone in Rheumatoid Arthritis of the Knee

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.

Study Overview

• Status: Unknown
• Conditions: Rheumatoid Arthritis of Knee
• Intervention / Treatment: Drug: Intra-articular Tocilizumab; Drug: Intra-articular 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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intra-articular Tocilizumab; Tocilizumab, solution, 80mg intra-articular.	Drug: Intra-articular Tocilizumab; Patients will be randomly chosen to be intra-articular injected of tocilizumab injection
ACTIVE_COMPARATOR: Intra-articular Compound Betamethasone; Compound betamethasone, solution, 14mg intra-articular	Drug: Intra-articular Compound Betamethasone; Patients will be randomly chosen to be intra-articular injected of compound betamethasone injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2017
• Primary Completion (ANTICIPATED): December 12, 2017
• Study Completion (ANTICIPATED): March 3, 2018

Study Registration Dates

• First Submitted: June 22, 2017
• First Submitted That Met QC Criteria: July 11, 2017
• First Posted (ACTUAL): July 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone
• Other Study ID Numbers: ChinaPLAGH(Intraarticular+TCZ)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No