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

NCT04345458 | Completed Phase 3

• 1 other identifier: C301S-AS III
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ankylosing Spondylitis

Keywords

prefilled liquid etanercept; lyophilized etanercept powder; ankylosing spondylitis

Outcome Measures

Primary Outcomes (1)

• 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.

  at week 24

Secondary Outcomes (12)

• the proportion of patients who achieved ASAS40, ASAS partial remission

  at weeks 12 and 24

• the proportion of patients who achieved ASAS 5/6

  at weeks 12 and 24

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

  at weeks 12 and 24

• the proportion of patients who achieved BASDAI50

  at weeks 12 and 24

• the proportion of patients who achieved improvement in BASDAI

  at weeks 12 and 24

Other Outcomes (1)

• AEs

  at weeks 2, 4, 8, 12, 16, 20 and 24

Study Arms (3)

group I

EXPERIMENTAL

twice weekly 25 mg prefilled liquid etanercept

Drug: prefilled liquid etanercept(Yisaipu)

group II

EXPERIMENTAL

once weekly 50 mg prefilled liquid etanercept

Drug: prefilled liquid etanercept(Yisaipu)

group III

ACTIVE COMPARATOR

25 mg twice weekly lyophilized etanercept powder

Drug: lyophilized etanercept powder(Yisaipu)

Interventions

prefilled liquid etanercept(Yisaipu) DRUG

group I; group II

lyophilized etanercept powder(Yisaipu) DRUG

group III

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• History of active tubercolosis, or radiographic evidence of present or previous history of pulmonary tubercolosis
• close contact with patients with tubercolosis, or with high risk of infection of tubercolosis such as immune suppression status
• 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.

Sponsors & Collaborators

• Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.: lead

Study Sites (1)

Chinese PLA General Hospital clinical trial center

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (1)

• Zhao D, He D, Bi L, Wu H, Liu Y, Wu Z, Li Y, Wang G, Li X, Bao C, Jiang L, Zhang Z, Xiao W, Tong G, Wang D, Huang F. Safety and Efficacy of Prefilled Liquid Etanercept-Biosimilar Yisaipu for Active Ankylosing Spondylitis: A Multi-Center Phase III Trial. Rheumatol Ther. 2021 Mar;8(1):361-374. doi: 10.1007/s40744-021-00276-1. Epub 2021 Feb 9.

  PMID: 33559842 DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 14, 2020
• Study Start: March 6, 2014
• Primary Completion: July 13, 2015
• Study Completion: July 20, 2015
• Last Updated: April 14, 2020

Record last verified: 2020-04

Locations

CN (1)