Predictive Value of Active Sacroiliitis in MRI for Flare Among Chinese Patients with Axial Spondyloarthritis in Remission.
Qing Zheng, Wen Liu, Yu Huang...
https://pubmed.ncbi.nlm.nih.gov/33598865Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID03425812
Effects of Nonsteroidal Anti-Inflammatory Drugs in Recurrence of Spondyloarthritis Patients After Remission: A Multicenter, Randomized, Controlled Study
Led by The First Affiliated Hospital of Xiamen University · Updated on 2022-04-18
140
Participants Needed
1
Research Sites
156 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
Researchers are evaluating the effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on the recurrence of axial spondyloarthritis in patients who have achieved remission. This multicenter, randomized controlled trial aims to compare the recurrence rates between patients who stop NSAIDs therapy and those who continue it after remission. The study focuses on understanding how NSAIDs influence disease activity and flare rates in this condition. Participants are randomly assigned to one of two groups: one group will withdraw from NSAIDs therapy following a washout period, while the other will continue their NSAIDs treatment. The study does not use masking, and treatments are monitored over a period of 24 weeks. Various disease activity and functional indices, imaging scores, and blood tests will be assessed to evaluate changes and flare rates between the groups. During the 24-week study period, participants will undergo regular evaluations including Ankylosing Spondylitis Disease Activity Score (ASDAS), patient global assessments, back pain measurements, functional and metrology indices, quality of life questionnaires, and blood tests for inflammation markers. Imaging assessments such as MRI and X-rays will also be performed at specified intervals. Researchers will monitor relapse timing, flare rates, and structural changes to better understand NSAIDs therapy's role in disease management.
CONDITIONS
Brief Title
Effects of Nonsteroidal Anti-Inflammatory Drugs in Recurrence of Spondyloarthritis Patients After Remission
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Capable of giving informed consent and complying with the protocol examinations
- Diagnosed with axial spondyloarthritis meeting ASAS 2009 classification criteria
- Currently in remission with ASDAS score less than 1.3
- ASDAS less than 1.3 maintained for three consecutive evaluations every four weeks
- Laboratory values within specified normal ranges for hemoglobin, white blood cell count, platelets, liver and kidney function
- 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 episodes of axial spondyloarthritis
- Recent ulcers, gastrointestinal conditions, or bleeding within three months
- Acute infection or acute attack of chronic infection at screening
- Invasive fungal or opportunistic bacterial infections within six months before screening
- Other autoimmune diseases affecting medication evaluation such as inflammatory enteritis, psoriasis, or uveitis
- Congestive heart failure, coronary heart disease, or serious arrhythmia
- Severe, progressive, uncontrolled organ or systemic diseases
- Conditions affecting study compliance such as prolonged travel, planned relocation, mental illness, or lack of motivation to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 24 weeks
Participants will either withdraw or continue NSAIDs therapy to study its effects on disease recurrence.
Visits at baseline, Week 12, Week 16, and Week 24 for assessments and monitoring
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
Loading map...
Research Team
S
Shi Guixiu, PhD
Z
Zheng Qing, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here