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

• Conditions: Rheumatoid Arthritis of Ankle
• Interventions: Procedure: arthroscopic synovectomy

• Registration Number: NCT04454034
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-01
• Status Verified: 2020-06
• Study First Submitted: 2020-06-27
• Study First Submitted QC: 2020-06-27
• Study First Posted: 2020-07-01
• Last Update Submitted: 2021-06-25
• Last Update Posted: 2021-06-28
• Primary Completion: 2021-07-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group1	arthroscopic synovectomy	The refractory elbow RA who undergo arthroscopic synovectomy

Primary Outcome Measures

Name	Time	Method
ACR70 remission	6 months after surgery	the percent of patients who meet ACR70 remission

Secondary Outcome Measures

Name	Time	Method
Disease Activity Score (DAS) 28-erythrocyte sedimentation rate (ESR) (range 0-9.4)	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
swollen joint count	1,3,6 and 12 months after surgery	the number of swollen joints
tender joint count	1,3,6 and 12 months after surgery	the number of tender joints

Trial Locations

Locations (1)

Peking Univerisity Third Hospital; 🇨🇳 Beijing, Beijing, China