NCT03425812 Effects of Nonsteroidal Anti-Inflammatory Drugs in Recurrence of Spondyloarthritis Patients After Remission
| NCT ID | NCT03425812 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital of Xiamen University |
| Condition | Axial Spondyloarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2018-02-15 |
| Primary Completion | 2025-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2018-02-15 with a primary completion date of 2025-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The multicenter, randomized controlled trial is to investigate and evaluate the effect of NSAIDs therapy on recurrence in patients with axial spondyloarthritis;
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.).
Contact & Investigator
Shi Guixiu, PhD
STUDY DIRECTOR
The First Affiliated Hospital of Xiamen University
Frequently Asked Questions
Who can join the NCT03425812 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Axial Spondyloarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03425812 currently recruiting?
Yes, NCT03425812 is actively recruiting participants. Contact the research team at Gshi@xmu.edu.cn for enrollment information.
Where is the NCT03425812 trial being conducted?
This trial is being conducted at Xiamen, China.
Who is sponsoring the NCT03425812 clinical trial?
NCT03425812 is sponsored by The First Affiliated Hospital of Xiamen University. The principal investigator is Shi Guixiu, PhD at The First Affiliated Hospital of Xiamen University. The trial plans to enroll 140 participants.