Arthroscopic Synovectomy Combined With DMARDs in the Treatment of Refractory Elbow Rheumatoid Arthritis

June 25, 2021 updated by: Peking University Third Hospital
Rheumatoid arthritis (RA) is an autoimmune disease characterized by chronic and aggressive polyarthritis. The prevalence of RA in China is about 0.42%. Arthroscopic synovectomy (AS) is an important method to save the function of joint in the treatment of refractory RA. The clinical trial is to study the value of AS combine with DMARDs in the early stage of refractory RA.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking Univerisity Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

the patients who fullfill the Eligibility Criteria

Description

Inclusion Criteria:

  • The patients who fulfilled the 1987 ACR（American College of Rheumatology) or 2010 ACR/EULAR（European League Against Rheumatism） RA classification criteria.
  • The age is more than 18 years old and less than 60 years old.
  • They received stable traditional DMARDs (including Chrysopidae, leflunomide, sulfasalazine, hydroxychloroquine, eilamod) or biological dmrads (including tumor necrosis factor antagonists, IL(Interleukin)-6 receptor antagonists, CD20 monoclonal antibodies) for at least 6 months.
  • The disease is still in the active stage, which means the disease activity score (DAS28) is more than 3.2, and the elbow joint function is obviously limited.
  • The patient agreed to undergo arthroscopic synovectomy.
  • No contraindications were found.

Exclusion Criteria:

  • The disease is in remission.
  • The patient has contraindications.
  • Arthroscopic synovectomy was performed in different patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group1
The refractory elbow RA who undergo arthroscopic synovectomy
Procedure: arthroscopic synovectomy
arthroscopic synovectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ACR70 remission
Time Frame: 6 months after surgery
the percent of patients who meet ACR70 remission
6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Activity Score (DAS) 28-erythrocyte sedimentation rate (ESR) (range 0-9.4)
Time Frame: 1,3,6 and 12 months after surgery
Remission: 2.6 Low activity: 2.6 to ,3.2 Moderate activity: 3.2 to 5.1 High activity: .5.1
1,3,6 and 12 months after surgery
tender joint count
Time Frame: 1,3,6 and 12 months after surgery
the number of tender joints
1,3,6 and 12 months after surgery
swollen joint count
Time Frame: 1,3,6 and 12 months after surgery
the number of swollen joints
1,3,6 and 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2019

Primary Completion (ANTICIPATED)

July 31, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

June 27, 2020

First Submitted That Met QC Criteria

June 27, 2020

First Posted (ACTUAL)

July 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 28, 2021

Last Update Submitted That Met QC Criteria

June 25, 2021

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2019072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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