Rheumatoid Arthritis (RA)NCT06791980
Integrated Care Approach for Rheumatoid Arthritis Patients
A study testing ETLA in people with Rheumatoid Arthritis (RA), run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
The goal of this study is to learn about the long-term effects of integrated care approach in persons over the age of 20 who take part in integrated care approach to treat their rheumatoid arthritis (RA). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- ETLA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2024to 31 Dec 2025
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age of at least 20 years; willingness to participate in the survey; having the physician-diagnosed RA with the International Classification of Diseases, 9th Revision, Clinical Modification code of 714.0
Who cannot join
- having physician-based diagnosis of cognitive impairment and with the ability to express opinion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Pro-inflammatory Cytokines and Depressive Symptoms in Patients With Rheumatoid Arthritis: Evaluating the Impact of an Integrated Care Approach
The goal of this study is to learn about the long-term effects of integrated care approach in persons over the age of 20 who take part in integrated care approach to treat their rheumatoid arthritis (RA). The main question is to explore whether adding the integrated care approach into routine care can lower pro-inflammatory cytokines and depressive symptom in RA persons over age 20 when taken long-term to treat RA?
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- ETLA
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETLAOther
To assess the long-term effects of integrated case management model involving traditional Chinese medicine (CM-TCM) model. The persons participating will be invited to enroll in this stage, and they will be assigned to receive either the usual care or a usual care plus integrated 3-month CM-TCM
| Study group | Role | What they receive |
|---|---|---|
| Routine care | No intervention | This consisted of consultation about disease symptoms and conventional disease management. |
| ETLA care | Experimental | Subhects in the experimental group receive exercise training plus laser acupuncture Receives: Other: ETLA |
What is being measured
The primary outcome is the main question the study is designed to answer.
cytokines
Serum cytokine levels contained interleukin (IL)-6, IL-1, IL-17 and tumor necrosis factor (TNF)-alpha,
Measured: From enrollment to the end of treatment at 12 weeks"
Secondary outcomes (1)
depressive symptom
It is measured by self-reported scale
Measured: From enrollment to the end of treatment at 12 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Oct 2024
- Primary completion31 Oct 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- To set up an exercise training plus laser acupuncture (ETLA) program and to assess its long-term effects towards changes of metabolic profiles, pro-inflammatory cytokines, and muscle functions among RA persons.
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalin Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tzung-Yi Tsai, Dalin Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791980
- Sponsor's protocol ID
- B11204006
- Status last verified
- Apr 2026
- First submitted
- 20 Jan 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Pro-inflammatory Cytokines and Depressive Symptoms in Patients With Rheumatoid Arthritis: Evaluating the Impact of an Integrated Care Approach
- ClinicalTrials.gov ID
- NCT06791980
- Acronym / sponsor ID
- B11204006
- Conditions
- Rheumatoid Arthritis (RA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Dalin Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 24 Jan 2025 (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.
The goal of this study is to learn about the long-term effects of integrated care approach in persons over the age of 20 who take part in integrated care approach to treat their rheumatoid arthritis (RA). The main question is to explore whether adding the integrated care approach into routine care can lower pro-inflammatory cytokines and depressive symptom in RA persons over age 20 when taken long-term to treat RA?
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To set up an exercise training plus laser acupuncture (ETLA) program and to assess its long-term effects towards changes of metabolic profiles, pro-inflammatory cytokines, and muscle functions among RA persons.
| Arm | Type | Receives |
|---|---|---|
| Routine care | No intervention | –This consisted of consultation about disease symptoms and conventional disease management. |
| ETLA care | Experimental | Other: ETLASubhects in the experimental group receive exercise training plus laser acupuncture |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age of at least 20 years; willingness to participate in the survey; having the physician-diagnosed RA with the International Classification of Diseases, 9th Revision, Clinical Modification code of 714.0
Key exclusion criteria (1 listed)
- having physician-based diagnosis of cognitive impairment and with the ability to express opinion
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 |
|---|---|---|
| ETLATo assess the long-term effects of integrated case management model involving traditional Chinese medicine (CM-TCM) model. The persons participating will be invited to enroll in this stage, and they will be assigned to receive either the usual care or a usual care plus integrated 3-month CM-TCM | Other | ETLA care |
Primary outcome
cytokines
Time frame: From enrollment to the end of treatment at 12 weeks"
Serum cytokine levels contained interleukin (IL)-6, IL-1, IL-17 and tumor necrosis factor (TNF)-alpha,
1 secondary outcome
depressive symptom
Time frame: From enrollment to the end of treatment at 12 weeks"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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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?
A study testing ETLA in people with Rheumatoid Arthritis (RA), run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 9 Apr 2026. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
cytokines (time frame: From enrollment to the end of treatment at 12 weeks"). 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 9 Apr 2026.