Effects of Nonsteroidal Anti-Inflammatory Drugs in Recurrence of Spondyloarthritis Patients After Remission

• Status: Recruiting
• Trial end date: 2028-12-20
• Target enrollment: 0
• Participant gender: All

Summary

The multicenter, randomized controlled trial is to investigate and evaluate the effect of NSAIDs therapy on recurrence in patients with axial spondyloarthritis;

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Xiamen University
• Collaborators: First Affiliated Hospital of Fujian Medical University; Fujian Medical University Union Hospital; Peking University Shenzhen Hospital; Quanzhou Orthopedic-traumatological Hospital of Fujian Traditional Chinese Medicine University; Zhangzhou Affiliated Hospital of Fujian Medical University
• Treatments: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal

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.).