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
Updated on 25 January 2021
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 IdentifierNCT03425812
SponsorThe First Affiliated Hospital of Xiamen University
Last Modified on25 January 2021

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<1.3then continuous to evaluate every four weeks for three times and ASDAS<1.3 each time
Laboratory results must fulfill following requirements: Hb85g/L3.5109/LWBC Count 10109/LPlatelet count Normal lower limit; Liver function (ALTTBIL) 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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