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Treatment of Axial Spondyloarthritis by Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein

NCT02364479 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-12-19

No results posted yet for this study

Summary

This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy and safety of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc fusion protein injection (Yisaipu®) in the treatment of active axial spondyloarthritis(SpA). The primary purpose is to assess the different situations in maintaining treatment programme in SpA patients with controlled inflammation by Yisaipu®. And the second purpose is to assess the eficacy and safety of Yisaipu® in axial SpAs. The trial will include 150 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 48 weeks. Patients who complete the 72-week therapy or achieve disease-flare criteria during the blind stage would finish the study.

Conditions

  • Spondyloarthritis

Interventions

DRUG

50mg Yisaipu

Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 50mg per week

DRUG

25mg etanercept

Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 25mg per week

DRUG

Placebo

The injection method and frequency of placebo is the same as the other arms.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Jieruo Gu, Professor · 3rd Affiliated Hospital of Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-10
Primary Completion
2016-07-28
Completion
2016-08-28

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT02364479 on ClinicalTrials.gov