Clinical trial NCT02960035: A Study of the MASEI in the Treatment of Anti-TNF Blocker to Peripheral Tendonitis in Patients With Spondyloarthritis
Official title: A Prospective Study of the Use of the Madrid Ultrasound Scoring System in the Treatment of Anti-TNF Blocker to Peripheral Tendonitis in Patients With Spondyloarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spondyloarthropathy
Keywords: Mardird sonographic enthesis index
Spondyloarthropathy
Ultrasonics
Etanercept
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Mardird sonographic enthesis index (MASEI) was one of the most wide used scoring systems for peripheral enthesitis and the only one based on OMERACT definition of enthesopathy by EULAR. The primary purpose is to assess the MASEI to discover the value of US in diagnosis and prognosis. The second prupose is to assess different maintaining treatment programme in SpA patients with improvement of MASEI. The trial will include 96 patients with stable NSAIDs therapy, and at the first stage they will receive 24-week full-dose of Yisaipu®. Then at the second stage the patients who achieve low disease activity (LDA, ASDAS\<2.1) at 24th week will be randomizedly divided into three group: full-dose of Yisaipu® group, half-dose of Yisaipu® group and placebo group. And the blind stage will last for 24 weeks. Patients who complete the 48-week therapy or achieve disease-flare criteria during the blind stage would finish the study.

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

Primary outcomes:
measure: The change of Mardird sonographic enthesis index (MASEI) at 24 weeks
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
name: Jieruo Gu, Prof.
role: STUDY_DIRECTOR
References: