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

NCT04345458 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 640

Last updated 2020-04-14

No results posted yet for this study

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

Interventions

DRUG

prefilled liquid etanercept(Yisaipu)

DRUG

lyophilized etanercept powder(Yisaipu)

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-06
Primary Completion
2015-07-13
Completion
2015-07-20

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04345458 on ClinicalTrials.gov