A Study of the MASEI in the Treatment of Anti-TNF Blocker to Peripheral Tendonitis in Patients Wi… (NCT02960035) | Clinical Trial Compass
CompletedPhase 4
A Study of the MASEI in the Treatment of Anti-TNF Blocker to Peripheral Tendonitis in Patients With Spondyloarthritis
China96 participantsStarted 2014-04
Plain-language summary
This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc fusion protein injection (Yisaipu®) in the treatment of peripheral enthesitis in active axial spondyloarthritis(SpA) patients.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 s…
What they're measuring
1
The change of Mardird sonographic enthesis index (MASEI) at 24 weeks