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

Rheumatoid Arthritis of Ankle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04454034
• Other study ID #: M2019072
• Status: Enrolling by invitation
• Start date: August 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2020
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 25
• Est. completion date: December 31, 2021
• Est. primary completion date: July 31, 2021
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis of Ankle

Intervention

Procedure:
• arthroscopic synovectomy
arthroscopic synovectomy

Locations

Country	Name	City	State
China	Peking Univerisity Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR70 remission	the percent of patients who meet ACR70 remission	6 months after surgery
Secondary	Disease Activity Score (DAS) 28-erythrocyte sedimentation rate (ESR) (range 0-9.4)	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
Secondary	tender joint count	the number of tender joints	1,3,6 and 12 months after surgery
Secondary	swollen joint count	the number of swollen joints	1,3,6 and 12 months after surgery