Ankylosing SpondylitisNCT06846021
Integral Single-cell Landscape of Immunological Hallmarks for Ankylosing Spondylitis
A study testing Disease status in people with Ankylosing Spondylitis, run by Fujian Provincial Hospital at 1 site in China.
Trial summary
Three HLA-B27-positive health donors (HDs) with matching age were enrolled via genetic screening, and fourteen AS patients were recruited at Fujian provincial hospital from May to July 2021. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Disease status
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2021to 25 Aug 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of ankylosing spondylitis Clinical hallmarks and imaging evidences
Who cannot join
- Pregnant patients Other diseases, tumors and injuries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-cell Immunomics Research on the Onset and Different Outcomes in Patients with Ankylosing Spondylitis
Three HLA-B27-positive health donors (HDs) with matching age were enrolled via genetic screening, and fourteen AS patients were recruited at Fujian provincial hospital from May to July 2021. All AS patients satisfied the modified New York (NY) criteria, and the categorization of three disease groups (EA, LD and RM) was according to clinical hallmarks and imaging evidences. The five patients in the EA group were in the early stage of disease, showing obvious symptoms, and had not yet received standard treatments, including various NSAIDs and DMARDs. The five patients in the LD group were all disabled, and confirmed by radiographic evidence of structural damage in hip joints and spinal deformity. The four patients in the RM group received standardized treatment under the guidance of specialist doctors, and maintained clinical remission and normal laboratory indicators for over six months. Patients in both EA and RM groups were confirmed to have no structural damage or deformities by radiographic evidences.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Disease status
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disease statusOther
According to the disease status, patients are divided into four groups including healthy donors, initial patients with high activity, patients with deformities and patients with clinical remission
| Study group | Role | What they receive |
|---|---|---|
| The investigators performed single-cell RNA sequencing based on PBMCs | Experimental | Not described Receives: Other: Disease status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the immunological characteristics regarding the onset and outcomes of ankylosing-spondylitis patients relying on single-cell transcriptomics analysis for four groups of subjects (including health donors and patients in early active stage, l
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start17 May 2021
- Primary completion30 Jun 2021
- Study completion25 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dianshan Ke, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846021
- Sponsor's protocol ID
- K2022-09-055
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-cell Immunomics Research on the Onset and Different Outcomes in Patients with Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT06846021
- Acronym / sponsor ID
- K2022-09-055
- Conditions
- Ankylosing Spondylitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 25 Aug 2021 (actual)
- First posted
- 25 Feb 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.
Three HLA-B27-positive health donors (HDs) with matching age were enrolled via genetic screening, and fourteen AS patients were recruited at Fujian provincial hospital from May to July 2021. All AS patients satisfied the modified New York (NY) criteria, and the categorization of three disease groups (EA, LD and RM) was according to clinical hallmarks and imaging evidences. The five patients in the EA group were in the early stage of disease, showing obvious symptoms, and had not yet received standard treatments, including various NSAIDs and DMARDs. The five patients in the LD group were all disabled, and confirmed by radiographic evidence of structural damage in hip joints and spinal deformity. The four patients in the RM group received standardized treatment under the guidance of specialist doctors, and maintained clinical remission and normal laboratory indicators for over six months. Patients in both EA and RM groups were confirmed to have no structural damage or deformities by radiographic evidences.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The investigators performed single-cell RNA sequencing based on PBMCs | Experimental | Other: Disease status |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of ankylosing spondylitis Clinical hallmarks and imaging evidences
Key exclusion criteria (1 listed)
- Pregnant patients Other diseases, tumors and injuries
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 |
|---|---|---|
| Disease statusAccording to the disease status, patients are divided into four groups including healthy donors, initial patients with high activity, patients with deformities and patients with clinical remission | Other | The investigators performed single-cell RNA sequencing based on PBMCs |
Primary outcome
Assessment of the immunological characteristics regarding the onset and outcomes of ankylosing-spondylitis patients relying on single-cell transcriptomics analysis for four groups of subjects (including health donors and patients in early active stage, l
Time frame: 8 months
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 4 Mar 2025.
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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 Disease status in people with Ankylosing Spondylitis, run by Fujian Provincial 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 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 4 Mar 2025. 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?
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?
Assessment of the immunological characteristics regarding the onset and outcomes of ankylosing-spondylitis patients relying on single-cell transcriptomics analysis for four groups of subjects (including health donors and patients in early active stage, l (time frame: 8 months). 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 4 Mar 2025.