Status:
RECRUITING
Effects of Nonsteroidal Anti-Inflammatory Drugs in Recurrence of Spondyloarthritis Patients After Remission
Lead Sponsor:
The First Affiliated Hospital of Xiamen University
Collaborating Sponsors:
First Affiliated Hospital of Fujian Medical University
Peking University Shenzhen Hospital
Conditions:
Axial Spondyloarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The multicenter, randomized controlled trial is to investigate and evaluate the effect of NSAIDs therapy on recurrence in patients with axial spondyloarthritis;
Detailed Description
To investigate the recurrence rate in remission patients who withdraw NSAIDs therapy in axial spondyloarthritis;
Eligibility Criteria
Inclusion
- 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
- 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.).
Key Trial Info
Start Date :
February 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2028
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03425812
Start Date
February 15 2018
End Date
December 20 2028
Last Update
April 18 2022
Active Locations (1)
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1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003