An interventional study of To withdraw NSAIDs therapy and To continue NSAIDs therapy in Axial Spondyloarthritis, sponsored by The First Affiliated Hospital of Xiamen University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-18.
Sponsored by The First Affiliated Hospital of Xiamen University · Not applicable, Interventional, and Treatment
Among 16 studies in Axial Spondyloarthritis with a site in China — 6 open to participants now, 7 under way, none of them phase 3. Axial Spondyloarthritis · China.
Among the 16 studies in Axial Spondyloarthritis with a site in China, this one is the 11th largest by planned enrollment of the 13 interventional ones that give a count, is one of 2 that started in 2018, is one of 2 with no phase, and was the 2nd registered.
186 studies on the registry are indexed under Axial Spondyloarthritis; 56 are open to participants now.
Browse Axial Spondyloarthritis studies →6 of the 16 studies in Axial Spondyloarthritis with a site in China are open now. Recruiting first, the newest first:
Chinese PLA General Hospital · Sites in China
Ages 18–45
China-Japan Friendship Hospital · Sites in China
Ages 18+
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Sites in China
Ages 18+
The First Affiliated Hospital of Xiamen University · Sites in China
Ages 18–65
Chinese PLA General Hospital · Sites in China
Ages 18–65
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 38 Axial Spondyloarthritis studies recruiting now, 20 (53%) set no upper age limit and 12 (32%) stop at 75 or younger; 5 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 140 is above the median of 108 across 122 interventional studies indexed under Axial Spondyloarthritis.
Median enrollment 274 across the 13 interventional studies, 247 across the 3 observational. Of the 9 that completed or were terminated, 4 (44%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 16 have an industry lead sponsor. The 10 most frequent:
The First Affiliated Hospital of Xiamen University is the lead sponsor of 120 studies on the registry; 81 are open to participants now.
The First Affiliated Hospital of Xiamen University has 2 studies filed under Axial Spondyloarthritis — fewer than ten, so there is no comparison to draw.
2 of the studies in Axial Spondyloarthritis with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07133633Merck Sharp & Dohme LLCA Clinical Study of Tulisokibart (MK-7240) to Treat Radiographic Axial Spondyloarthritis (MK-7240-013) | 2027-03-29 |
| NCT07724847Chinese PLA General HospitalMulticenter Validation of the 2025 Classification Criteria for Axial Spondyloarthritis | 2027-04-10 |
Add all 2 to your calendar (.ics) → With an account.
Among the 16 studies in Axial Spondyloarthritis with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The multicenter, randomized controlled trial is to investigate and evaluate the effect of NSAIDs therapy on recurrence in patients with axial spondyloarthritis;
To investigate the recurrence rate in remission patients who withdraw NSAIDs therapy in axial spondyloarthritis;
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
To withdraw NSAIDS therapy
Drug: To withdraw NSAIDs therapy
To continue NSAIDS therapy
Drug: To continue NSAIDs therapy
NSAIDs therapy will be withdrew after washout period.
Also known as: Non-NSAIDs, Break-off (on-demand) NSAID therapy, Break-off NSAID use (on-demand) group
NSAIDs therapy will be continued.
Also known as: NSAIDs, Regular (continuous) NSAID therapy, Regular (continuous) group
Percentage of participants with Ankylosing Spondylitis Disease Activity Score (ASDAS) active disease
ASDAS active disease is defined as ΔASDAS-CRP≥0.9. The ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation.
Time frame: From Week 0 (baseline) to Week24
Change in Patient global assessment of disease activity
Participant rated instrument to measure participants' global assessment of disease activity on a 10 cm visual analogue scale, ranging from no activity to highest possible activity.
Time frame: From Week 0 (baseline) to Week24
Change in total Back Pain
Participants assessed the total back pain they had in the previous 1 week on a scale from 0 (no pain) to 10 (most severe pain).
Time frame: From Week 0 (baseline) to Week24
Change in Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major Ankylosing Spondylitis (AS) symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.
Time frame: From Week 0 (baseline) to Week24
Change in Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
The BASFI is a participant's self-assessment represented as a mean (VAS; 0 to 10) of 10 questions, 8 of which relate to the participant's functional anatomy and 2 of which relate to a participant's ability to cope with everyday life. An increase along the scale indicates a worsening condition.
Time frame: From Week 0 (baseline) to Week24
Change in Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
Time frame: From Week 0 (baseline) to Week24
Change in Short Form-36 Physical Component Summary (SF-36 PCS)
The change from Baseline in Short Form-36 Physical Component Summary (SF-36 PCS)
Time frame: From Week 0 (baseline) to Week24
Change in European Quality of Life-5 Dimensions (EQ-5D) Questionnaire
The EQ-5D is an international, standardized, generic instrument for describing and valuing health status.In description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. In evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS).Visual analogue scale is the second part of the questionnaire, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine".
Time frame: From Week 0 (baseline) to Week24
Change in Chest Expansion
Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values.
Time frame: From Week 0 (baseline) to Week24
Change in Maastricht Ankylosing Spondylitis Enthesitis Index (MASES)
The MASES evaluation will be conducted at the designated study visits to assess the presence or absence of enthesitis at 13 different sites, noting the subjects' responses.
Time frame: From Week 0 (baseline) to Week24
Change in Number of swelling and tendons affected by enthesitis
An assessment of 44 swelling joints and 46 tendons joints will be done by physical examination at the designated study visits. Joint swelling will be classified as present (1), absent (0), replaced (9), or no assessment (NA).
Time frame: From Week 0 (baseline) to Week24
Change in Blood samples: C-reactive protein (CRP) and Erythrocyte sedimentation rate(ESR)
General and specific markers of inflammation. ESR will be evaluated at the site and expressed in mm/hg (1st hour).
Time frame: From Week 0 (baseline) to Week24
Observation of relapse time after withdrawal of NSAIDs in remission patients
ASDAS active disease is defined as ΔASDAS-CRP≥0.9
Time frame: From Week 0 (baseline) to Week24
The difference of flare rate between different treatment groups
ASDAS active disease is defined as ΔASDAS-CRP≥0.9
Time frame: Week12 and Week24
The difference of flare rate between in patients with different sacroiliac joint grades on X-ray among different groups.
To grade radiographic sacroiliitis according to the New York criteria: grade0 normal; grade1 suspicious; grade2 minimal sacroiliitis; grade3 moderate sacroiliitis; grade4 ankylosis.
Time frame: Week12 and Week24
The difference of osteophyte formation between different groups on Modified Stoke ankylosing spondylitis spine score (mSASSS).
mSASSS focuses on the anterior vertebral body angles from the lower T12 endplate to the upper S1 endplate on a lateral radiograph. Each angle is scored 0 (normal), 1 (shiny corner sign, squaring, or sclerosis), 2 (enthesophyte), or 3 (bridging), so that the total score can range from 0 to 72.
Time frame: Week0 and Week24
Comparison of BASFI and BASMI scores between different groups
The BASFI is a participant's self-assessment represented as a mean (VAS; 0 to 10) of 10 questions, 8 of which relate to the participant's functional anatomy and 2 of which relate to a participant's ability to cope with everyday life. An increase along the scale indicates a worsening condition. BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
Time frame: Week12 and Week24
Differences in MRI scores among different groups by SPARCC SSS method.
The SPARCC SSS method was developed based on semicoronal T1WSE sequences of the sacroiliac joints (SIJ). The transitional slice is identified by scrolling from anterior to posterior through the SIJ and viewing DICOM images depicting semicoronal slices through the joint. Scoring ranges are fat metaplasia (0-40), erosion (0-40), backfill (0-20), and ankylosis (0-20).
Time frame: weeks-16, week 0, week 12 and week 24
The difference of flare rate in patients with different MRI scores of sacroiliac joint.
MRI scores are measured by SPARCC SSS method.
Time frame: Week0 and Week24
Plan to share: Undecided
Started Feb 2018 (actual). Primary completion is estimated for Dec 2025, 94 months after the start.
Of 45 non-industry interventional studies with no phase under Axial Spondyloarthritis, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 42. This study's planned 94 months is above that.
Counting every sponsor, half of 45 studies reached it within 28 months; a quarter within 11 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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The First Affiliated Hospital of Xiamen University →