Arthroscopic Synovectomy Combined With DMARDs in the Treatment of Refractory Elbow Rheumatoid Arthritis
1 other identifier
observational
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2019
CompletedFirst Submitted
Initial submission to the registry
June 27, 2020
CompletedFirst Posted
Study publicly available on registry
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJune 28, 2021
June 1, 2020
2 years
June 27, 2020
June 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ACR70 remission
the percent of patients who meet ACR70 remission
6 months after surgery
Secondary Outcomes (3)
Disease Activity Score (DAS) 28-erythrocyte sedimentation rate (ESR) (range 0-9.4)
1,3,6 and 12 months after surgery
tender joint count
1,3,6 and 12 months after surgery
swollen joint count
1,3,6 and 12 months after surgery
Study Arms (1)
Group1
The refractory elbow RA who undergo arthroscopic synovectomy
Interventions
Eligibility Criteria
the patients who fullfill the Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- The disease is in remission.
- The patient has contraindications.
- Arthroscopic synovectomy was performed in different patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Univerisity Third Hospital
Beijing, Beijing Municipality, 100191, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2020
First Posted
July 1, 2020
Study Start
August 1, 2019
Primary Completion
July 31, 2021
Study Completion
December 31, 2021
Last Updated
June 28, 2021
Record last verified: 2020-06