Axial SpondyloarthritisNCT03425812
Effects of Nonsteroidal Anti-Inflammatory Drugs in Recurrence of Spondyloarthritis Patients After Remission
A study testing To withdraw NSAIDs therapy and To continue NSAIDs therapy in people with Axial Spondyloarthritis, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
The multicenter, randomized controlled trial is to investigate and evaluate the effect of NSAIDs therapy on recurrence in patients with axial spondyloarthritis; Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- To withdraw NSAIDs therapy and To continue NSAIDs therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2018to 20 Dec 2028
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of giving informed consent and complying with the examination program of the protocol;
- Participants with axial SpA fulfilling the Assessment of Spondyloarthritis international Society 2009 (ASAS) axial SpA classification criteria;
- Participants must fulfill the criteria of maintaining remission of aSpA, defined as ASDAS<1.3；
- Participants must fulfill the criteria of remission of aSpA defined as ASDAS<1.3，then continuous to evaluate every four weeks for three times and ASDAS<1.3 each time.
- Laboratory results must fulfill following requirements: Hb≥85g/L；3.5×109/L≤WBC Count ≤10×109/L；Platelet count ≥ Normal lower limit; Liver function (ALT、TBIL) ≤Twofold of normal upper limit; Renal function (SCr) ≤Normal upper limit;
- The pregnancy test must be negative for women of childbearing age; Efficient contraception must be taken for both male and female participants during the trial period and within three months after the end of the trial.
Who cannot join
- Participants who previously have experienced allergic reactions to NSAIDs or sulfa-drugs;
- Participants who are intolerant of NSAIDs;
- Participants who are in active axSpA episodes;
- Participants with previous or currant ulcers and/or gastrointestinal conditions or bleeding in three months
- Participants who were in acute infection or acute attack of chronic infection during screening period;
- At the time of screening, participants who were in the acute stage of acute infection or chronic infection, and if the acute infection had improved, they could be re-screened.
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- Participants who suffer from invasive fungal infections (e.g. histoplasma, coccidiosis's, candida, aspergillus, blastomyces, pneumocystis, etc.) within the first 6 months of screening; Or opportunistic bacterial infections (e.g. bacterial, viral or other infections, including Legionella and Listeria);
- Participants with other autoimmune diseases which are expected to influence the evaluation of experimental medications, such as inflammatory enteritis, psoriasis, uveitis, etc.
- Participants with previous or currant congestive heart failure, coronary heart disease, serious arrhythmia;
- Participants with severe, progressive, uncontrolled vital organ and systematic disorders, and other conditions that are considered inappropriate to participate in this trial;
- Participants with circumstances that may affect the compliance (e.g. prolonged travel or leave, planned relocation, mental illness, lack of motivation to participate, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Shi Guixiu, PhD, 13600932661, Gshi@xmu.edu.cn
Zheng Qing, PhD, 18650383162, drmichaelzheng@qq.com
About this study
Official title: Effects of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) in Recurrence of Spondyloarthritis (SPA) Patients After Remission：A Multicenter, Randomized, Controlled Study
The multicenter, randomized controlled trial is to investigate and evaluate the effect of NSAIDs therapy on recurrence in patients with axial spondyloarthritis;
Read the detailed description
To investigate the recurrence rate in remission patients who withdraw NSAIDs therapy in axial spondyloarthritis;
- Conditions
- Axial Spondyloarthritis
- Being tested
- To withdraw NSAIDs therapy, To continue NSAIDs therapy
- Keywords
- Axial Spondyloarthritis, Anti-Inflammatory Drugs, Flare
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To withdraw NSAIDs therapyDrug
Also called Non-NSAIDs, Break-off (on-demand) NSAID therapy, Break-off NSAID use (on-demand) group
NSAIDs therapy will be withdrew after washout period.
To continue NSAIDs therapyDrug
Also called NSAIDs, Regular (continuous) NSAID therapy, Regular (continuous) group
NSAIDs therapy will be continued.
| Study group | Role | What they receive |
|---|---|---|
| Non- NSAIDS group | Experimental | To withdraw NSAIDS therapy Receives: Drug: To withdraw NSAIDs therapy |
| NSAIDS group | Active comparator | To continue NSAIDS therapy Receives: Drug: To continue NSAIDs therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Week 0 (baseline) to Week24
Secondary outcomes (18)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Week0 and Week24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start15 Feb 2018
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Fujian Medical University, Peking University Shenzhen Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University, Quanzhou Orthopedic-traumatological Hospital of Fujian Traditional Chinese Medicine University, Fujian Medical University Union Hospital
- Responsible party
- Sponsor
- Investigators
- Shi Guixiu, PhD, Study director, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425812
- Sponsor's protocol ID
- 20180101
- Status last verified
- Apr 2022
- First submitted
- 19 Jan 2018
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zheng Q, Liu W, Huang Y, Gao Z, Wu Y, Wang X, Cai M, He Y, Chen S, Wang B, Liu L, Chen S, Huang H, Zheng L, Kang R, Zeng X, Chen J, Chen H, Chen J, Li Z, Shi G. Predictive Value of Active Sacroiliitis in MRI for Flare Among Chinese Patients with Axial Spondyloarthritis in Remission. Rheumatol Ther. 2021 Mar;8(1):411-424. doi: 10.1007/s40744-021-00279-y. Epub 2021 Feb 18.
PubMed 33598865
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) in Recurrence of Spondyloarthritis (SPA) Patients After Remission：A Multicenter, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT03425812
- Acronym / sponsor ID
- 20180101
- Conditions
- Axial Spondyloarthritis
- Keywords
- Axial Spondyloarthritis, Anti-Inflammatory Drugs, Flare
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Fujian Medical University, Peking University Shenzhen Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University, Quanzhou Orthopedic-traumatological Hospital of Fujian Traditional Chinese Medicine University, Fujian Medical University Union Hospital
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Dec 2028 (estimated)
- First posted
- 8 Feb 2018 (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 multicenter, randomized controlled trial is to investigate and evaluate the effect of NSAIDs therapy on recurrence in patients with axial spondyloarthritis;
Detailed description
To investigate the recurrence rate in remission patients who withdraw NSAIDs therapy in axial spondyloarthritis;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non- NSAIDS group | Experimental | Drug: To withdraw NSAIDs therapyTo withdraw NSAIDS therapy |
| NSAIDS group | Active comparator | Drug: To continue NSAIDs therapyTo continue NSAIDS therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Capable of giving informed consent and complying with the examination program of the protocol;
- Participants with axial SpA fulfilling the Assessment of Spondyloarthritis international Society 2009 (ASAS) axial SpA classification criteria;
- Participants must fulfill the criteria of maintaining remission of aSpA, defined as ASDAS<1.3；
- Participants must fulfill the criteria of remission of aSpA defined as ASDAS<1.3，then continuous to evaluate every four weeks for three times and ASDAS<1.3 each time.
- Laboratory results must fulfill following requirements: Hb≥85g/L；3.5×109/L≤WBC Count ≤10×109/L；Platelet count ≥ Normal lower limit; Liver function (ALT、TBIL) ≤Twofold of normal upper limit; Renal function (SCr) ≤Normal upper limit;
Key exclusion criteria (11 listed)
- Participants who previously have experienced allergic reactions to NSAIDs or sulfa-drugs;
- Participants who are intolerant of NSAIDs;
- Participants who are in active axSpA episodes;
- Participants with previous or currant ulcers and/or gastrointestinal conditions or bleeding in three months
- Participants who were in acute infection or acute attack of chronic infection during screening period;
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 |
|---|---|---|
| To withdraw NSAIDs therapyAlso: Non-NSAIDs, Break-off (on-demand) NSAID therapy, Break-off NSAID use (on-demand) groupNSAIDs therapy will be withdrew after washout period. | Drug | Non- NSAIDS group |
| To continue NSAIDs therapyAlso: NSAIDs, Regular (continuous) NSAID therapy, Regular (continuous) groupNSAIDs therapy will be continued. | Drug | NSAIDS group |
Primary outcome
Percentage of participants with Ankylosing Spondylitis Disease Activity Score (ASDAS) active disease
Time frame: From Week 0 (baseline) to Week24
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.
18 secondary outcomes
Change in Patient global assessment of disease activity
Time frame: From Week 0 (baseline) to Week24
Change in total Back Pain
Time frame: From Week 0 (baseline) to Week24
Change in Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: From Week 0 (baseline) to Week24
Change in Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: From Week 0 (baseline) to Week24
Change in Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time frame: From Week 0 (baseline) to Week24
Change 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
Time frame: From Week 0 (baseline) to Week24
Change in Chest Expansion
Time frame: From Week 0 (baseline) to Week24
Change in Maastricht Ankylosing Spondylitis Enthesitis Index (MASES)
Time frame: From Week 0 (baseline) to Week24
Change in Number of swelling and tendons affected by enthesitis
Time frame: From Week 0 (baseline) to Week24
Change in Blood samples: C-reactive protein (CRP) and Erythrocyte sedimentation rate(ESR)
Time frame: From Week 0 (baseline) to Week24
Observation of relapse time after withdrawal of NSAIDs in remission patients
Time frame: From Week 0 (baseline) to Week24
The difference of flare rate between different treatment groups
Time frame: Week12 and Week24
The difference of flare rate between in patients with different sacroiliac joint grades on X-ray among different groups.
Time frame: Week12 and Week24
The difference of osteophyte formation between different groups on Modified Stoke ankylosing spondylitis spine score (mSASSS).
Time frame: Week0 and Week24
Comparison of BASFI and BASMI scores between different groups
Time frame: Week12 and Week24
Differences in MRI scores among different groups by SPARCC SSS method.
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.
Time frame: Week0 and Week24
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 18 Apr 2022.
- Derived from this study: PubMed 33598865Zheng Q, Liu W, Huang Y, Gao Z, Wu Y, Wang X, Cai M, He Y, Chen S, Wang B, Liu L, Chen S, Huang H, Zheng L, Kang R, Zeng X, Chen J, Chen H, Chen J, Li Z, Shi G. Predictive Value of Active Sacroiliitis in MRI for Flare Among Chinese Patients with Axial Spondyloarthritis in Remission. Rheumatol Ther. 2021 Mar;8(1):411-424. doi: 10.1007/s40744-021-00279-y. Epub 2021 Feb 18.
- 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.
Shi Guixiu, PhD study director
The First Affiliated Hospital of Xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing To withdraw NSAIDs therapy and To continue NSAIDs therapy in people with Axial Spondyloarthritis, run by The First Affiliated Hospital of Xiamen University 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 11 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 18 Apr 2022. 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?
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 Shi Guixiu, PhD (86-0592-13600932661, Gshi@xmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with Ankylosing Spondylitis Disease Activity Score (ASDAS) active disease (time frame: From Week 0 (baseline) to Week24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03425812, which also lists 1 linked publication.
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 18 Apr 2022.