Actively Recruiting
Effects of Nonsteroidal Anti-Inflammatory Drugs in Recurrence of Spondyloarthritis Patients After Remission
Led by The First Affiliated Hospital of Xiamen University · Updated on 2022-04-18
140
Participants Needed
1
Research Sites
565 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Xiamen University
Lead Sponsor
F
First Affiliated Hospital of Fujian Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The multicenter, randomized controlled trial is to investigate and evaluate the effect of NSAIDs therapy on recurrence in patients with axial spondyloarthritis;
CONDITIONS
Official Title
Effects of Nonsteroidal Anti-Inflammatory Drugs in Recurrence of Spondyloarthritis Patients After Remission
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give informed consent and follow the study procedures
- Diagnosed with axial spondyloarthritis meeting the ASAS 2009 classification criteria
- In remission with ASDAS score less than 1.3
- Maintained remission with ASDAS below 1.3 for three consecutive assessments every four weeks
- Laboratory tests within specified normal ranges (Hb ≥85g/L; WBC count ≤10×10⁹/L; platelet count above normal lower limit; liver and kidney function within limits)
- Negative pregnancy test for women of childbearing age
- Effective contraception used by both male and female participants during the trial and for three months after
You will not qualify if you...
- History of allergic reactions to NSAIDs or sulfa drugs
- Intolerance to NSAIDs
- Active axial spondyloarthritis episodes
- Ulcers, gastrointestinal conditions, or bleeding within the past three months
- Acute infection or acute attack of chronic infection during screening
- Invasive fungal infections within six months before screening or opportunistic bacterial infections
- Other autoimmune diseases affecting evaluation, such as inflammatory enteritis, psoriasis, or uveitis
- Previous or current congestive heart failure, coronary heart disease, or serious arrhythmia
- Severe, progressive, uncontrolled vital organ or systemic disorders
- Conditions that may impair study compliance (e.g., prolonged travel, planned relocation, mental illness, lack of motivation)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
Research Team
S
Shi Guixiu, PhD
CONTACT
Z
Zheng Qing, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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