Spondyloarthritis (SpA)Phase 4NCT06707194
Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis
A Phase 4 study testing Etanercept and Benzathine Penicillin in people with Spondyloarthritis (SpA) and Ankylosing Spondylitis (AS), run by Nanfang Hospital, Southern Medical University at 6 sites in China.
Trial summary
The purpose of the study is to verify the clinical feasibility of Benzathine penicillin (BPG) /Etanercept (ETN) combination regimen in patients with spondyloarthritis (SpA) and at the same time compare Benzathine penicillin /Etanercept combination regimen and Etanercept maintenance therapy in reducing disease… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Spondyloarthritis (SpA), Ankylosing Spondylitis (AS)
- What is being tested?
- Etanercept and Benzathine Penicillin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- 6 sitesChina
- Study dates
- 14 Jun 2025to 31 Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The following patients would be included: (1) The subjects voluntarily participate and sign an informed consent form; (2) patients aged 18-59 years; (3) According to the following guidelines or diagnostic criteria, a standardized diagnosis of spinal arthritis patients is made, which meets one of the following diagnostic criteria: ① 2009 ASAS classification criteria for axial spinal arthritis; ② Classification criteria for ASAS peripheral spondyloarthritis in 2011. And subjects with spinal arthritis who are in a relatively active period (ASDAS-CRP>1.2 )of infection;
Who cannot join
- he exclusion criteria are as follows: (1) Subjects with nasopharyngitis, active tuberculosis, inflammatory bowel disease and other infections, other rheumatic and immune diseases, malignant tumors, and concomitant bone and joint diseases; (2) Individuals who are allergic to the components of the experimental drug; (3)Severe abnormalities in liver and kidney function (liver enzymes ≥ 2 times normal; creatinine ≥ 2 times normal); (4)Pregnant, preparing for pregnancy or breastfeeding women; (5)Moderate to severe heart failure (New York Heart Association grades 3-4); (6)Some researchers believe that other situations are not suitable for the use of etanercept or other experimental drugs; (7)Active gastrointestinal ulcer/bleeding; (8) According to the researcher's judgment, it is not suitable to participate in this study; (9)Patients in the acute phase of streptococcal infection: present with clinical manifestations of acute pharyngitis, acute tonsillitis, scarlet fever, and streptococcal pyoderma, and ASO or ADNS>normal range, and/or CRP>normal range.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Not yet recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
- Not yet recruiting
Ganzhou People's Hospital
Ganzhou, Jiangxi, 341000
- Recruiting
Nan Fang Hospital, Southern Medical University
Guangzhou, Guangdong, 510080
Jun Xiao, Dr, 18665000156, orthopaedxj@163.com
- Recruiting
Nan Fang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Jun Xiao, 0086-20-18665000156, orthopaedxj@163.com
- Not yet recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230001
- Not yet recruiting
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia, 010010
About this study
Official title: Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis: a Multicenter Randomized Controlled Clinical Study
The purpose of the study is to verify the clinical feasibility of Benzathine penicillin (BPG) /Etanercept (ETN) combination regimen in patients with spondyloarthritis (SpA) and at the same time compare Benzathine penicillin /Etanercept combination regimen and Etanercept maintenance therapy in reducing disease activity, improving patients' clinical symptoms and body function scores, enhancing quality of life, improving imaging performance and safety.
Read the detailed description
This trial is a randomised, double-blinded, placebo-controlled, polycentric study. The study consisted of a screening period (up to 2 weeks before randomization), a treatment period (24 weeks), and 5 follow-up visits (Weeks 0, 6, 12,18 and 24).
After a 2-week preparation period, 340 patients with SpA will be randomly and equally assigned to either experimental group consisting of BPG (injection form, 1.2 million units of intramuscular injection, once every two weeks) with ETN (injection form, 25mg of hypodermic injection, twice a week) or the control group consisting of placebos (injection form, once every two weeks) with ETN (injection form, 25mg of hypodermic injection, twice a week),with treatment lasting for 12 weeks. After 12 weeks of treatment, the label will be opened, and all patients will choose to use BPG combined with ETN maintenance therapy for another 12 weeks of treatment. Follow-up will be conducted at baseline, 6 weeks,12 weeks,18 weeks and 24 weeks after the end of treatment. The primary outcome is the response rate of ASAS40 in patients after 12 weeks of medication. The secondary outcomes are the severity of symptoms, disease activity, quality of life, and imaging progression scale scores of patients at each follow-up point. We will synchronize the recording of adverse events to compare the safety of the two treatment regimens
- Being tested
- Etanercept, Benzathine Penicillin, Placebo
- Keywords
- spondyloarthritis, benzathine penicillin, Etanercept
- Medical subject headings
- Spondylarthritis, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptBiological
Prefilled syringe, 25mg of hypodermic injection, twice a week
Benzathine PenicillinDrug
Preparation of suspension with appropriate amount of sterilized water (4-5ml) for injection, 1.2 million units of intramuscular injection, once every two weeks
PlaceboOther
Preparation of suspension with appropriate amount of sterilized water (4-5ml) for injection, intramuscular injection, once every two weeks
| Study group | Role | What they receive |
|---|---|---|
| BPG with ETN | Experimental | Blinded "BPG with ETN" from Week 0 to Week 12, open-label "BPG with ETN" from Week 12 to Week 24. Receives: Biological: Etanercept; Drug: Benzathine Penicillin |
| Placebo with ETN | Placebo comparator | Blinded "Placebo with ETN" from Week 0 to Week 12, open-label "BPG with ETN" from Week 12 to Week 24. Receives: Biological: Etanercept; Drug: Benzathine Penicillin; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient ASAS40 remission rate after 12 weeks of patient medication
Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the VAS signifies higher severity.
Measured: Week 12
Secondary outcomes (15)
Improvement rate of Spondyloarthritis Research Consortium of Canada Score （SPARCC）
The patients' sacroiliac joint MRIs were scored with reference to the Spondyloarthritis Research Consortium of Canada Score criteria, and the patients' pre-treatment scores were compared to calculate the rate of improvement
Measured: Baseline and Week 12、24
ASAS20 remission rate
Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS20 response is defined as an improvement of ≥20% and ≥1 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the VAS signifies higher severity.
Measured: Week 6、12、18、24
Improvement rate of Spondyloarthritis Research Consortium of Canada Sacroiliac Joint Structural Score（SPARCCSSS）
The patients' sacroiliac joint MRIs were scored with reference to the Spondyloarthritis Research Consortium of Canada Sacroiliac Joint Structural Score criteria, and the patients' pre-treatment scores were compared to calculate the rate of improvement
Measured: Baseline and Week 12、24
Change From Baseline in Patient Global Assessment
Follow-up questionnaires were administered to the patients, including 1. average activity score of the spondylitis condition in the past week (0-10: never active to very active); 2. activity score of spondylitis in nocturnal pain (0-10: never active to very active)
Measured: Baseline and Week 6、12、18、24
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index （BASDAI）Score
Follow-up questionnaires were administered to patients, including: 1. overall degree of fatigue/drowsiness felt in the past week; 2. overall degree of neck, back, and hip pain felt in the past week; 3. overall degree of painful swelling in other joints (excluding neck, back, and hip pain) felt in the past week; 4. overall degree of discomfort felt in the past week due to touch or pressure; 5. overall degree of morning stiffness felt in the past week Overall degree of morning stiffness felt while awake; 6. Duration of morning stiffness when awake. Ranges from no impact (0 points) to very significant (10 points)
Measured: Baseline and Week 6、12、18、24
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
Participants assessed their ability to perform 10 selected activities (e.g., putting on socks or tights without help or aids, bending forward from the waist to pick up a pen from the floor without an aid) during the preceding week. Responses ranged from 0 (easy) to 100 (impossible). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 100.
Measured: Baseline and Week 6、12、18、24
C-reactive protein-based Ankylosing Spondylitis Disease Activity Score（ASDASCRP）
0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1)
Measured: Baseline and Week 6、12、18、24
Change From Baseline in the scale of quality of life for ankylosing spondylitis (SQOL-AS)
The scale consists of four areas: physiological functioning, psychological state, social functioning, and self-perception, with eight items to rate physiological functioning, six to rate psychological state, five to rate social functioning, and six to rate self-perception
Measured: Baseline and Week 6、12、18、24
Terms and Conditions for Using the 36-Item Short Form Survey（SF-36）（Physical Functioning (PF)、Mental Health (MH) ）
The scale consists of two dimensions: physical functioning and mental health, with 10 items assessing physical functioning and 5 items assessing mental health.
Measured: Baseline and Week 6、12、18、24
Bath Ankylosing Spondylitis Metrology Index (BASMI) Score
measure the lateral spinal flexion、tragus-to-wall distance、lumbar flexion (modified Schober)、maximal intermalleolar distance、cervical rotation
Measured: Baseline and Week 12、24
Change From Baseline in Maastricht ankylosing spondylitis enthesitis （MASES） score
costochondral 1 right/left、costochondral 7 right/left、spina iliaca anterior superior right/left、crista iliaca right/left、spina iliaca posterior right/left、processus spinosus L5、achilles tendon, proximal insertion right/left. All sites are scored as 0 or 1. The MASES is the sum of all site scores (from 0 to 13)
Measured: Baseline and Week 12、24
Change From Baseline in Bath Ankylosing Spondylitis-Global （BAS-G） Score
patient evaluation : 1. assess the impact of ankylosing spondylitis on health status in the past 1 week; 2. assess the impact of ankylosing spondylitis on health status in the past 6 months. (Scores range from 0 (none) to 10 (very severe).)
Measured: Baseline and Week 6、12、18、24
Change From Baseline in Work Productivity and Activity Impairment Specific Health Problem (WPAI-SHP) Questionnaire
patient evaluation : 1. To what extent has the disease affected productivity while at work during the past seven days; 2. To what extent has the disease affected the ability to perform daily activities (other than work)? (Everyday activities are housework, shopping, child care, exercise, study, etc.) (Scores range from 0 (mild) to 10 (very severe))
Measured: Baseline and Week 6、12、18、24
Change From Baseline in Swollen Joint Count, Tender Joint Count
Number of joints assessed by the patient for swelling and tenderness. All sites are scored as 0 or 1.
Measured: Baseline and Week 12、24
Change From Baseline in Indicators of streptococcal infection
Patients had blood drawn for ASO, ADNase B, CRP, ESR indicators
Measured: Baseline and Week 6、12、18、24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start14 Jun 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spondyloarthritis (SpA)Studies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707194
- Sponsor's protocol ID
- NFEC-2025-283
- Other IDs
- NFSC-2024-060
- Status last verified
- Jun 2025
- First submitted
- 24 Nov 2024
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis: a Multicenter Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06707194
- Acronym / sponsor ID
- NFEC-2025-283
- Keywords
- spondyloarthritis, benzathine penicillin, Etanercept
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 14 Jun 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 27 Nov 2024 (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 purpose of the study is to verify the clinical feasibility of Benzathine penicillin (BPG) /Etanercept (ETN) combination regimen in patients with spondyloarthritis (SpA) and at the same time compare Benzathine penicillin /Etanercept combination regimen and Etanercept maintenance therapy in reducing disease activity, improving patients' clinical symptoms and body function scores, enhancing quality of life, improving imaging performance and safety.
Detailed description
This trial is a randomised, double-blinded, placebo-controlled, polycentric study. The study consisted of a screening period (up to 2 weeks before randomization), a treatment period (24 weeks), and 5 follow-up visits (Weeks 0, 6, 12,18 and 24).
After a 2-week preparation period, 340 patients with SpA will be randomly and equally assigned to either experimental group consisting of BPG (injection form, 1.2 million units of intramuscular injection, once every two weeks) with ETN (injection form, 25mg of hypodermic injection, twice a week) or the control group consisting of placebos (injection form, once every two weeks) with ETN (injection form, 25mg of hypodermic injection, twice a week),with treatment lasting for 12 weeks. After 12 weeks of treatment, the label will be opened, and all patients will choose to use BPG combined with ETN maintenance therapy for another 12 weeks of treatment. Follow-up will be conducted at baseline, 6 weeks,12 weeks,18 weeks and 24 weeks after the end of treatment. The primary outcome is the response rate of ASAS40 in patients after 12 weeks of medication. The secondary outcomes are the severity of symptoms, disease activity, quality of life, and imaging progression scale scores of patients at each follow-up point. We will synchronize the recording of adverse events to compare the safety of the two treatment regimens
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPG with ETN | Experimental | Biological: Etanercept, Drug: Benzathine PenicillinBlinded "BPG with ETN" from Week 0 to Week 12, open-label "BPG with ETN" from Week 12 to Week 24. |
| Placebo with ETN | Placebo comparator | Biological: Etanercept, Drug: Benzathine Penicillin, Other: PlaceboBlinded "Placebo with ETN" from Week 0 to Week 12, open-label "BPG with ETN" from Week 12 to Week 24. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The following patients would be included: (1) The subjects voluntarily participate and sign an informed consent form; (2) patients aged 18-59 years; (3) According to the following guidelines or diagnostic criteria, a standardized diagnosis of spinal arthritis patients is made, which meets one of the following diagnostic criteria: ① 2009 ASAS classification criteria for axial spinal arthritis; ② Classification criteria for ASAS peripheral spondyloarthritis in 2011. And subjects with spinal arthritis who are in a relatively active period (ASDAS-CRP>1.2 )of infection;
Key exclusion criteria (1 listed)
- he exclusion criteria are as follows: (1) Subjects with nasopharyngitis, active tuberculosis, inflammatory bowel disease and other infections, other rheumatic and immune diseases, malignant tumors, and concomitant bone and joint diseases; (2) Individuals who are allergic to the components of the experimental drug; (3)Severe abnormalities in liver and kidney function (liver enzymes ≥ 2 times normal; creatinine ≥ 2 times normal); (4)Pregnant, preparing for pregnancy or breastfeeding women; (5)Moderate to severe heart failure (New York Heart Association grades 3-4); (6)Some researchers believe that other situations are not suitable for the use of etanercept or other experimental drugs; (7)Active gastrointestinal ulcer/bleeding; (8) According to the researcher's judgment, it is not suitable to participate in this study; (9)Patients in the acute phase of streptococcal infection: present with clinical manifestations of acute pharyngitis, acute tonsillitis, scarlet fever, and streptococcal pyoderma, and ASO or ADNS>normal range, and/or CRP>normal range.
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 |
|---|---|---|
| EtanerceptPrefilled syringe, 25mg of hypodermic injection, twice a week | Biological | BPG with ETN, Placebo with ETN |
| Benzathine PenicillinPreparation of suspension with appropriate amount of sterilized water (4-5ml) for injection, 1.2 million units of intramuscular injection, once every two weeks | Drug | BPG with ETN, Placebo with ETN |
| PlaceboPreparation of suspension with appropriate amount of sterilized water (4-5ml) for injection, intramuscular injection, once every two weeks | Other | Placebo with ETN |
Primary outcome
Patient ASAS40 remission rate after 12 weeks of patient medication
Time frame: Week 12
Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the VAS signifies higher severity.
15 secondary outcomes
Improvement rate of Spondyloarthritis Research Consortium of Canada Score （SPARCC）
Time frame: Baseline and Week 12、24
ASAS20 remission rate
Time frame: Week 6、12、18、24
Improvement rate of Spondyloarthritis Research Consortium of Canada Sacroiliac Joint Structural Score（SPARCCSSS）
Time frame: Baseline and Week 12、24
Change From Baseline in Patient Global Assessment
Time frame: Baseline and Week 6、12、18、24
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index （BASDAI）Score
Time frame: Baseline and Week 6、12、18、24
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
Time frame: Baseline and Week 6、12、18、24
C-reactive protein-based Ankylosing Spondylitis Disease Activity Score（ASDASCRP）
Time frame: Baseline and Week 6、12、18、24
Change From Baseline in the scale of quality of life for ankylosing spondylitis (SQOL-AS)
Time frame: Baseline and Week 6、12、18、24
Terms and Conditions for Using the 36-Item Short Form Survey（SF-36）（Physical Functioning (PF)、Mental Health (MH) ）
Time frame: Baseline and Week 6、12、18、24
Bath Ankylosing Spondylitis Metrology Index (BASMI) Score
Time frame: Baseline and Week 12、24
Change From Baseline in Maastricht ankylosing spondylitis enthesitis （MASES） score
Time frame: Baseline and Week 12、24
Change From Baseline in Bath Ankylosing Spondylitis-Global （BAS-G） Score
Time frame: Baseline and Week 6、12、18、24
Change From Baseline in Work Productivity and Activity Impairment Specific Health Problem (WPAI-SHP) Questionnaire
Time frame: Baseline and Week 6、12、18、24
Change From Baseline in Swollen Joint Count, Tender Joint Count
Time frame: Baseline and Week 12、24
Change From Baseline in Indicators of streptococcal infection
Time frame: Baseline and Week 6、12、18、24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- 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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etanercept and Benzathine Penicillin in people with Spondyloarthritis (SpA) and Ankylosing Spondylitis (AS), run by Nanfang Hospital, Southern Medical University at 6 sites 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: looking for participants now, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Xiao (0086-20-18665000156, orthopaedxj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient ASAS40 remission rate after 12 weeks of patient medication (time frame: Week 12). 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 26 Jun 2025.