A Study of the MASEI in the Treatment of Anti-TNF Blocker to Peripheral Tendonitis in Patients With Spondyloarthritis
Spondyloarthropathy
About this trial
This is an interventional treatment trial for Spondyloarthropathy focused on measuring Mardird sonographic enthesis index, Spondyloarthropathy, Ultrasonics, Etanercept
Eligibility Criteria
Inclusion Criteria:
- Fulfill the 2009 ASAS criteria for axial spondyloarthritis(SpA), and without bilateral more than grave 2 or unilateral more than grave 3 sacroilitis on X ray plan
- Active disease phase of SpA, defined as BASDAI≥4 or ASDAS≥2.1
- Inadequate response to NSAID≥4 week
- Application of NSAID with stable dose for no less than 2 weeks
- Stable dose of prenisone for at least four weeks at ≤10mg per day if used at screening, or stop use for at least 4 weeks
- Stable dose of any DMARD for at least four weeks if used at screening, or stop use for at least 4 weeks
- Stop and receiving washing out for at least 4 week if receiving Chinese traditional drug for AS, physical treatment, vaccication or IVIG
The lab exam should achieve the criteria as below:
- Hb ≥ 85g/L
- 3.5×109/L ≤ WBC count ≤ 10×109/L
- PLT ≥ lower limit of normal range
- ALT ≤ 2 fold of upper limit of normal range
- serum creatine ≤ upper limit of normal range
- Negative pregnacy test for female patients. And promise to carry out contraception during the trial and 6 weeks after the trial is ended
- Sign the informed consent
Exclusion Criteria:
- Previous application of any biologic agents
- Allergic to any element of Yisaipu®
- Intolerance to NASID
- History of active tubercolosis, or radiographic evidence of present or previous history of pulmonary tubercolosis, or close contact with patients with tubercolosis, or with high risk of infection of tubercolosis such as immune suppression status, or strong positive of PPD skin test with diameter ≥10mm
- Presence of acute infection or acute onset of chronic infection at screen
- Invasive fungal infection or conditional infection within 6 months prior to screen
- Present or history of serious liver disease
- History of infection on artifitial joints
- Organ transplantation surgery within 6 months prior to screen
- Presence of other autoimmune diseases, including IBD, psoriasis, uveitis, SLE, multiple sclerosis, etc
- History of congestive heart failure
- History of malignancies within 5 years prior to screen, excluding complete resection of squamous cell carcinoma, or basal cell carcinoma or cervical carcinoma in situ
- AIDS or HIV infection
- History of lymphoma or lymphoproliferative disorders
- Presence of serious disorder of important organs or system
- Presence of factors which may influence the compliance
Sites / Locations
- Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
etanercept 50mg/week
etanercept 25mg/week
PLACEBO
Patients who entered the study continued on the same NSAIDs medications. The NSAIDs dose was kept unchanged throughout the study. All patients were provided with the once-weekly 50 mg dose in the form of etanercept for 24 weeks. After 24 weeks, those patients who had maintained a ASDAS-CRP ≤2.1 during period 1 will be randomised to one of three arms (period 2): this arms will receive ETN 50 mg weekly (unchanged). In all three arms, the patients continued NSAIDs, and other medications, at the same dose.
Patients who entered the study continued on the same NSAIDs medications. The NSAIDs dose was kept unchanged throughout the study. All patients were provided with the once-weekly 50 mg dose in the form of etanercept for 24 weeks. After 24 weeks, those patients who had maintained a ASDAS-CRP ≤2.1 during period 1 were randomised to one of three arms (period 2): this arms will receive ETN 25 mg weekly (half dose). In all three arms, the patients continued NSAIDs, and other medications, at the same dose.
Patients who entered the study continued on the same NSAIDs medications. The NSAIDs dose was kept unchanged throughout the study. All patients were provided with the once-weekly 50 mg dose in the form of etanercept for 24 weeks. After 24 weeks, those patients who had maintained a ASDAS-CRP ≤2.1 during period 1 were randomised to one of three arms (period 2): this arms will receive placebo weekly. In all three arms, the patients continued NSAIDs, and other medications, at the same dose.