The Comparative Study of Intra-articular Injection of Toc... | NCT03215407

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

NCT03215407

Sponsor

Chinese PLA General Hospital

Status

Unknown status

Last Update Posted

Jul 14, 2017Actual

Enrollment

60Estimated

Phase

Phase 4

Conditions

Rheumatoid Arthritis of Knee

Interventions

Intra-articular Tocilizumab
Intra-articular Compound Betamethasone

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2017Estimated

Primary Completion Date

Dec 12, 2017Estimated

Completion Date

Mar 3, 2018Estimated

First Submitted Date

Jun 22, 2017

First Submission Date that Met QC Criteria

Jul 11, 2017

First Posted Date

Jul 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2017

Last Update Posted Date

Jul 14, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Intra-articular Tocilizumab	Drug	Patients will be randomly chosen to be intra-articular injected of tocilizumab injection	Intra-articular Tocilizumab

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided