The multicenter, randomized controlled trial is to investigate and evaluate the effect of NSAIDs therapy on recurrence in patients with axial spondyloarthritis;
To investigate the recurrence rate in remission patients who withdraw NSAIDs therapy in axial spondyloarthritis;
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
NSAIDs therapy will be withdrew after washout period.
NSAIDs therapy will be continued.
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
RECRUITINGPercentage of participants with Ankylosing Spondylitis Disease Activity Score (ASDAS) active disease
ASDAS active disease is defined as ΔASDAS-CRP≥0.9. The ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation.
Time frame: From Week 0 (baseline) to Week24
Change in Patient global assessment of disease activity
Participant rated instrument to measure participants' global assessment of disease activity on a 10 cm visual analogue scale, ranging from no activity to highest possible activity.
Time frame: From Week 0 (baseline) to Week24
Change in total Back Pain
Participants assessed the total back pain they had in the previous 1 week on a scale from 0 (no pain) to 10 (most severe pain).
Time frame: From Week 0 (baseline) to Week24
Change in Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major Ankylosing Spondylitis (AS) symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.
Time frame: From Week 0 (baseline) to Week24
Change in Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
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The BASFI is a participant's self-assessment represented as a mean (VAS; 0 to 10) of 10 questions, 8 of which relate to the participant's functional anatomy and 2 of which relate to a participant's ability to cope with everyday life. An increase along the scale indicates a worsening condition.
Time frame: From Week 0 (baseline) to Week24
Change in Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
Time frame: From Week 0 (baseline) to Week24
Change in Short Form-36 Physical Component Summary (SF-36 PCS)
The change from Baseline in Short Form-36 Physical Component Summary (SF-36 PCS)
Time frame: From Week 0 (baseline) to Week24
Change in European Quality of Life-5 Dimensions (EQ-5D) Questionnaire
The EQ-5D is an international, standardized, generic instrument for describing and valuing health status.In description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. In evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS).Visual analogue scale is the second part of the questionnaire, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine".
Time frame: From Week 0 (baseline) to Week24
Change in Chest Expansion
Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values.
Time frame: From Week 0 (baseline) to Week24
Change in Maastricht Ankylosing Spondylitis Enthesitis Index (MASES)
The MASES evaluation will be conducted at the designated study visits to assess the presence or absence of enthesitis at 13 different sites, noting the subjects' responses.
Time frame: From Week 0 (baseline) to Week24
Change in Number of swelling and tendons affected by enthesitis
An assessment of 44 swelling joints and 46 tendons joints will be done by physical examination at the designated study visits. Joint swelling will be classified as present (1), absent (0), replaced (9), or no assessment (NA).
Time frame: From Week 0 (baseline) to Week24
Change in Blood samples: C-reactive protein (CRP) and Erythrocyte sedimentation rate(ESR)
General and specific markers of inflammation. ESR will be evaluated at the site and expressed in mm/hg (1st hour).
Time frame: From Week 0 (baseline) to Week24
Observation of relapse time after withdrawal of NSAIDs in remission patients
ASDAS active disease is defined as ΔASDAS-CRP≥0.9
Time frame: From Week 0 (baseline) to Week24
The difference of flare rate between different treatment groups
ASDAS active disease is defined as ΔASDAS-CRP≥0.9
Time frame: Week12 and Week24
The difference of flare rate between in patients with different sacroiliac joint grades on X-ray among different groups.
To grade radiographic sacroiliitis according to the New York criteria: grade0 normal; grade1 suspicious; grade2 minimal sacroiliitis; grade3 moderate sacroiliitis; grade4 ankylosis.
Time frame: Week12 and Week24
The difference of osteophyte formation between different groups on Modified Stoke ankylosing spondylitis spine score (mSASSS).
mSASSS focuses on the anterior vertebral body angles from the lower T12 endplate to the upper S1 endplate on a lateral radiograph. Each angle is scored 0 (normal), 1 (shiny corner sign, squaring, or sclerosis), 2 (enthesophyte), or 3 (bridging), so that the total score can range from 0 to 72.
Time frame: Week0 and Week24
Comparison of BASFI and BASMI scores between different groups
The BASFI is a participant's self-assessment represented as a mean (VAS; 0 to 10) of 10 questions, 8 of which relate to the participant's functional anatomy and 2 of which relate to a participant's ability to cope with everyday life. An increase along the scale indicates a worsening condition. BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
Time frame: Week12 and Week24
Differences in MRI scores among different groups by SPARCC SSS method.
The SPARCC SSS method was developed based on semicoronal T1WSE sequences of the sacroiliac joints (SIJ). The transitional slice is identified by scrolling from anterior to posterior through the SIJ and viewing DICOM images depicting semicoronal slices through the joint. Scoring ranges are fat metaplasia (0-40), erosion (0-40), backfill (0-20), and ankylosis (0-20).
Time frame: weeks-16, week 0, week 12 and week 24
The difference of flare rate in patients with different MRI scores of sacroiliac joint.
MRI scores are measured by SPARCC SSS method.
Time frame: Week0 and Week24