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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Shi Guixiu, PhD
• Email: Gshi@xmu.edu.cn
• Phone: 86-0592-13600932661

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.