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/33598865/Actively Recruiting
Led by The First Affiliated Hospital of Xiamen University · Updated on 2022-04-18
140
Participants Needed
1
Research Sites
156 weeks
Total Duration
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 therapys role in disease management.
CONDITIONS
Effects of Nonsteroidal Anti-Inflammatory Drugs in Recurrence of Spondyloarthritis Patients After Remission
S
Shi Guixiu, PhD
Z
Zheng Qing, PhD
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The First Affiliated Hospital of Xiamen University
Lead Sponsor
First Affiliated Hospital of Fujian Medical University
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Qing Zheng, Wen Liu, Yu Huang...
https://pubmed.ncbi.nlm.nih.gov/33598865/The First Affiliated Hospital of Xiamen University
Lead Sponsor
First Affiliated Hospital of Fujian Medical University
Collaborating Sponsor