Rheumatoid Arthritis of AnkleNCT04454034
Arthroscopic Synovectomy Combined With DMARDs in the Treatment of Refractory Elbow Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis of Ankle, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rheumatoid Arthritis of Ankle
- What is being tested?
- arthroscopic synovectomy
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
Study population: the patients who fullfill the Eligibility Criteria
Who may be able to join
- 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.
Who cannot join
- The disease is in remission.
- The patient has contraindications.
- Arthroscopic synovectomy was performed in different patients.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Univerisity Third Hospital
Beijing, Beijing Municipality, 100191
About this study
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.
- Conditions
- Rheumatoid Arthritis of Ankle
- Being tested
- arthroscopic synovectomy
- Keywords
- Rheumatoid Arthritis, Arthroscopic Synovectomy
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroscopic synovectomyProcedure or surgery
arthroscopic synovectomy
| Study group | Role | What they receive |
|---|---|---|
| Group1 | The refractory elbow RA who undergo arthroscopic synovectomy Receives: Procedure: arthroscopic synovectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR70 remission
the percent of patients who meet ACR70 remission
Measured: 6 months after surgery
Secondary outcomes (3)
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
Measured: 1,3,6 and 12 months after surgery
tender joint count
the number of tender joints
Measured: 1,3,6 and 12 months after surgery
swollen joint count
the number of swollen joints
Measured: 1,3,6 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 Aug 2019
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis of AnkleStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454034
- Sponsor's protocol ID
- M2019072
- Status last verified
- Jun 2020
- First submitted
- 27 Jun 2020
- Last updated
- 28 Jun 2021
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Synovectomy Combined With DMARDs in the Treatment of Refractory Elbow Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT04454034
- Acronym / sponsor ID
- M2019072
- Conditions
- Rheumatoid Arthritis of Ankle
- Keywords
- Rheumatoid Arthritis, Arthroscopic Synovectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group1 | – | Procedure: arthroscopic synovectomyThe refractory elbow RA who undergo arthroscopic synovectomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- the patients who fullfill the Eligibility Criteria
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- The disease is in remission.
- The patient has contraindications.
- Arthroscopic synovectomy was performed in different patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arthroscopic synovectomyarthroscopic synovectomy | Procedure or surgery | Group1 |
Primary outcome
ACR70 remission
Time frame: 6 months after surgery
the percent of patients who meet ACR70 remission
3 secondary outcomes
Disease Activity Score (DAS) 28-erythrocyte sedimentation rate (ESR) (range 0-9.4)
Time frame: 1,3,6 and 12 months after surgery
tender joint count
Time frame: 1,3,6 and 12 months after surgery
swollen joint count
Time frame: 1,3,6 and 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis of Ankle, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACR70 remission (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2021.