Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-01-04 @ 12:09 AM
Study NCT ID:
NCT02960035
Status:
COMPLETED
Last Update Posted:
2019-12-19
First Post:
2016-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the MASEI in the Treatment of Anti-TNF Blocker to Peripheral Tendonitis in Patients With Spondyloarthritis
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: