Safety and Efficacy Study of Prefilled Liquid Etanercept(Yisaipu) for Active Ankylosing Spondylitis

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.640 enrolled

Overview

This randomized, double-blind, phase III parallel-group non-inferiority study aimed to investigate the efficacy and safety of prefilled liquid etanercept (Yisaipu) versus lyophilized etanercept powder (Yisaipu) in active ankylosing spondylitis patients.

The study carried out between March 6, 2014 and July 13, 2015 across multiple medical centers in China enrolled adult active ankylosing spondylitis patients aged between 18 and 65 years. Patients were randomized in a 3:1:1 ratio to receive twice weekly 25 mg prefilled liquid etanercept for totally 24 injections (group I) or once weekly 50 mg prefilled liquid etanercept for totally 48 injections (group II), or 25 mg twice weekly lyophilized etanercept powder for totally 48 injections (group III). The primary efficacy outcome was the proportion of patients who achieved ASAS20 at week 24.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

640

Conditions

Ankylosing Spondylitis

Interventions

prefilled liquid etanercept(Yisaipu)DRUG

lyophilized etanercept powder(Yisaipu)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age 18-65，male or female * Sign the informed consent * Fulfill the 1966 AS New York criteria for axial spondyloarthritis(SpA) * Active disease phase of SpA, defined as BASDAI≥4 or night back pain≥4 at screening * Inadequate response to NSAID≥4 week * Application of NSAID with stable dose for no less than 2 weeks at screening * Stable dose of prenisone for at least four weeks at ≤10mg per day if used at screening, or stop oral use for at least 4 weeks or stop local injection at least 12 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 * Stop and receiving washing out for at least 12 week if receiving other biologics or other drug trials * 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 Exclusion Criteria: * Allergic condition or Allergic to IgG or any element of Yisaipu® * Clinical or radiographic evidence of Complete ankylosis of spine * Previous receiving TNF-a blockers therapy ≥3 months with poor response * Achieve any following tuberculosis criteria 1. History of active tubercolosis, or radiographic evidence of present or previous history of pulmonary tubercolosis 2. close contact with patients with tubercolosis, or with high risk of infection of tubercolosis such as immune suppression status 3. Strong positive of PPD skin test with diameter ≥10mm. at screen or within 3 weeks prior to screen * Presence of acute infection or acute onset of chronic infection at screen * Invasive fungal infection or conditional infection within 6 months prior to screen * HBS-Ag or HBC-Ab positive at screen or history of HBS/HBC infection * 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

Locations (1)

Chinese PLA General Hospital clinical trial center

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

the proportion of patients who achieved ASAS20

Axial SpondyloArthritis international Society (ASAS) ASAS20 was defined as an improvement of at least 20% in at least three of the following four domains: 1) patient global assessment VAS, 2) nocturnal back pain and total back pain VAS, 3) Bath AS Function Index (BASFI) VAS, and 4) inflammation (mean of intensity and duration of morning stiffness components from the an improvement at least one unit relative to baseline VAS score; no worsening in the remaining fourth domain.

Time frame: at week 24

Secondary Outcomes

the proportion of patients who achieved ASAS40, ASAS partial remission

Axial SpondyloArthritis international Society (ASAS) ASAS40 was defined as improvement of at least 40% in at least three of the four abovementioned domains and an absolute improvement of at least two versus baseline VAS scores and no worsening versus the baseline in the remaining fourth domain. ASAS partial remission was defined as VAS scores ≤2 in each of the four abovementioned domains.

Time frame: at weeks 12 and 24

the proportion of patients who achieved ASAS 5/6

Axial SpondyloArthritis international Society (ASAS) ASAS 5/6 was defined as an improvement of at least 20% in at least five of the following six domains: 1) C-reactive protein (CRP), and 2) spinalmobility (scoliosis) in addition to the four above mentioned domains

Time frame: at weeks 12 and 24

the proportion of patients who achieved the ASDAS clinically important and major improvement and inactive disease

Time frame: at weeks 12 and 24

the proportion of patients who achieved BASDAI50

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) BASDAI50 was defined as a 50% or greater improvement versus the baseline BASDAI.

Time frame: at weeks 12 and 24

Data from ClinicalTrials.gov

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