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

STATUS

Recruiting
End date

Dec 20, 2028
participants needed

140
sponsor

The First Affiliated Hospital of Xiamen University

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Updated on 3 May 2022

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renal function

remission

steroidal anti-inflammatory drugs

NSAID

Summary

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

Description

To investigate the recurrence rate in remission patients who withdraw NSAIDs therapy in axial spondyloarthritis;

Details

Condition	Axial Spondyloarthritis
Treatment	To withdraw NSAIDs therapy, To continue NSAIDs therapy
Clinical Study Identifier	NCT03425812
Sponsor	The First Affiliated Hospital of Xiamen University
Last Modified on	3 May 2022

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Eligibility		Yes	No	Not Sure
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.)

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