Investigating the effects of stopping anti-inflammatory drugs in patients with axial spondyloarthritis

Effects of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) in Recurrence of Spondyloarthritis (SPA) Patients After Remission：A Multicenter, Randomized, Controlled Study

This study is testing whether stopping anti-inflammatory drugs helps people with axial spondyloarthritis who are in remission stay that way without having flare-ups.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of Xiamen University (Academic / other)
• Locations: 1 site (Xiamen, Fujian)
• Trial ID: NCT03425812 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized controlled trial aims to evaluate the impact of withdrawing nonsteroidal anti-inflammatory drugs (NSAIDs) on the recurrence of axial spondyloarthritis in patients who are in remission. Participants who meet specific criteria will either continue or stop their NSAID therapy, and their recurrence rates will be monitored over time. The study will assess the effectiveness of NSAIDs in maintaining remission and preventing flare-ups in this patient population.

Who should consider this trial

Good fit: Ideal candidates are patients with axial spondyloarthritis who are currently in remission and meet the study's inclusion criteria.

Not a fit: Patients who are not in remission or do not meet the specific eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help determine the best management strategies for patients with axial spondyloarthritis, potentially improving their quality of life.

How similar studies have performed: Similar studies have shown varying results regarding the management of axial spondyloarthritis, making this approach both relevant and necessary for further exploration.

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.).

Where this trial is running

Xiamen, Fujian

• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Recruiting)

Study contacts

• Study coordinator: Shi Guixiu, PhD

Conditions Axial Spondyloarthritis; Anti-Inflammatory Drugs; Flare