The primary objective of this study is to evaluate the efficacy of safety of etanercept dose reduction combined with sulfasalazine in ankylosing spondylitis (AS) patients who have achieved a significant clinical response.
This single-centre, open-labeled randomized study will evaluate the efficacy of safety of etanercept dose reduction combined with sulfasalazine in patients who achieved a significant clinical response. AS patients who meet the inclusion criteria will take celecoxib (0.4g/d) during the whole period of study. In the first period, all patients will be given etanercept 50 mg subcutaneous injections weekly from baseline to week12. In the second period, patients who satisfied the criteria for disease remission will be randomized to one of the following three treatment arms: (1) Dose reduction arm: Patients will receive etanercept 50 mg subcutaneous injections every other weeks plus sulfasalazine (2g/d) oral administration till week24. (2) Dose maintenance arm: Etanercept remains unchange from week12 to week24. (3) Etanercept discontinuation arm: Patients will be treated with sulfasalazine (2g/d) oral administration till week24. In the third period, all patients will take sulfasalazine (2g/d) till week 48. Ankylosing spondylitis disease activity score (ASDAS), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Bath ankylosing spondylitis functional index (BASFI), Bath ankylosing spondylitis metrology index (BASMI),Spondyloarthritis research consortium of Canada(SPARCC) score for the sacroiliac joint and adverse effect will be assessed in the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
AS patients who satisfied the criteria for disease remission (ASDAS\<1.3) will be randomized to one of the three treatment arms. In the dose reduction arm, patients will receive etanercept 50 mg subcutaneous injections every other weeks .
AS patients who satisfied the criteria for disease remission (ASDAS\<1.3) will be randomized to one of the three treatment arms. In the dose maintenance arm, patients will receive etanercept 50 mg subcutaneous injections every weeks.
AS patients who satisfied the criteria for disease remission (ASDAS\<1.3) will take sulfasalazine (2g/d) from week12 to week48.
Change in ASDAS from baseline to week48.
ASDAS includes CRP (mg/L); Apart from the value of CRP, the four additional self-reported items (rated on 0-10 numerical rating scale \[NRS\]) included in this index are back pain, duration of morning stiffness, peripheral pain/swelling and patient global assessment of disease activity. The ASDAS scores are calculated as follows: ASDAS= (0.121×total back pain) + (0.110×subject global) + (0.073×peripheral pain/swelling) + (0.058×duration of morning stiffness) + (0.579×Ln(CRP+1)).
Time frame: Baseline, Week12, Week24, Week48
Change in ESR from baseline to week48.
ESR is a laboratory test that provides a non-specific measure of inflammation. This test assesses the rate at which red blood cells fall in a test tube and is measured in mm/h. Normal range is 0 to 30 mm/h. A higher rate is consistent with inflammation.
Time frame: Baseline, Week12, Week24, Week48
Change in CRP from baseline to week48.
CRP is a marker of inflammation and measured in mg/L. A higher level is consistent with inflammation.
Time frame: Baseline, Week12, Week24, Week48
Change in BASFI from baseline to Week48.
BASFI is a validated self assessment tool that determines the degree of functional limitation in AS patients. Participants answered 10 questions, consisting of 8 specific questions regarding function in AS patients and 2 questions reflecting the participant's ability to cope with everyday life. Each question was answered on a 0-10 scale (0 being no problem and 10 being the worst problem), the sum of which (divided by 10) resulted in the BASFI score (0-10).
Time frame: Baseline, Week12, Week24, Week48
Change in BASMI from baseline to Week48.
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.
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Celecoxib (0.4g/d) will be the background therapy.
Time frame: Baseline, Week12, Week24, Week48
Change in SPARCC score for the sacroiliac joint from baseline to Week48.
SPARCC score for the sacroiliac joint was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion/1 = increased signal. For each slice, the score is increased by 1 for each joint that exhibits an intense signal in any quadrant. Also, for each slice, an additional score of 1 will be given for each joint that includes a lesion demonstrating continuous increased signal of a depth ≥1 cm from the articular surface. The maximum possible score is 72.
Time frame: Baseline, Week12, Week24, Week48
Percentage of participants with serious adverse events (SAEs) or adverse events (AEs) by co-morbidity from baseline to Week48.
Any untoward medical occurrence in a participant who received study regents was considered an AE, without regard to possibility of relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Baseline, Week12, Week24, Week48