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A Study of the MASEI in the Treatment of Anti-TNF Blocker to Peripheral Tendonitis in Patients With Spondyloarthritis

Primary Purpose

Spondyloarthropathy

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
50mg etanercept
25mg etanercept
placebo
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondyloarthropathy focused on measuring Mardird sonographic enthesis index, Spondyloarthropathy, Ultrasonics, Etanercept

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Fulfill the 2009 ASAS criteria for axial spondyloarthritis(SpA), and without bilateral more than grave 2 or unilateral more than grave 3 sacroilitis on X ray plan
  • Active disease phase of SpA, defined as BASDAI≥4 or ASDAS≥2.1
  • Inadequate response to NSAID≥4 week
  • Application of NSAID with stable dose for no less than 2 weeks
  • Stable dose of prenisone for at least four weeks at ≤10mg per day if used at screening, or stop use for at least 4 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
  • 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
  • Sign the informed consent

Exclusion Criteria:

  • Previous application of any biologic agents
  • Allergic to any element of Yisaipu®
  • Intolerance to NASID
  • History of active tubercolosis, or radiographic evidence of present or previous history of pulmonary tubercolosis, or close contact with patients with tubercolosis, or with high risk of infection of tubercolosis such as immune suppression status, or strong positive of PPD skin test with diameter ≥10mm
  • Presence of acute infection or acute onset of chronic infection at screen
  • Invasive fungal infection or conditional infection within 6 months prior to screen
  • Present or history of serious liver disease
  • 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

Sites / Locations

  • Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

etanercept 50mg/week

etanercept 25mg/week

PLACEBO

Arm Description

Patients who entered the study continued on the same NSAIDs medications. The NSAIDs dose was kept unchanged throughout the study. All patients were provided with the once-weekly 50 mg dose in the form of etanercept for 24 weeks. After 24 weeks, those patients who had maintained a ASDAS-CRP ≤2.1 during period 1 will be randomised to one of three arms (period 2): this arms will receive ETN 50 mg weekly (unchanged). In all three arms, the patients continued NSAIDs, and other medications, at the same dose.

Patients who entered the study continued on the same NSAIDs medications. The NSAIDs dose was kept unchanged throughout the study. All patients were provided with the once-weekly 50 mg dose in the form of etanercept for 24 weeks. After 24 weeks, those patients who had maintained a ASDAS-CRP ≤2.1 during period 1 were randomised to one of three arms (period 2): this arms will receive ETN 25 mg weekly (half dose). In all three arms, the patients continued NSAIDs, and other medications, at the same dose.

Patients who entered the study continued on the same NSAIDs medications. The NSAIDs dose was kept unchanged throughout the study. All patients were provided with the once-weekly 50 mg dose in the form of etanercept for 24 weeks. After 24 weeks, those patients who had maintained a ASDAS-CRP ≤2.1 during period 1 were randomised to one of three arms (period 2): this arms will receive placebo weekly. In all three arms, the patients continued NSAIDs, and other medications, at the same dose.

Outcomes

Primary Outcome Measures

The change of Mardird sonographic enthesis index (MASEI) at 24 weeks
The change of Mardird sonographic enthesis index (MASEI) from week 0 to week24

Secondary Outcome Measures

Full Information

First Posted
October 6, 2016
Last Updated
December 17, 2019
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02960035
Brief Title
A Study of the MASEI in the Treatment of Anti-TNF Blocker to Peripheral Tendonitis in Patients With Spondyloarthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondyloarthropathy
Keywords
Mardird sonographic enthesis index, Spondyloarthropathy, Ultrasonics, Etanercept

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
etanercept 50mg/week
Arm Type
Experimental
Arm Description
Patients who entered the study continued on the same NSAIDs medications. The NSAIDs dose was kept unchanged throughout the study. All patients were provided with the once-weekly 50 mg dose in the form of etanercept for 24 weeks. After 24 weeks, those patients who had maintained a ASDAS-CRP ≤2.1 during period 1 will be randomised to one of three arms (period 2): this arms will receive ETN 50 mg weekly (unchanged). In all three arms, the patients continued NSAIDs, and other medications, at the same dose.
Arm Title
etanercept 25mg/week
Arm Type
Experimental
Arm Description
Patients who entered the study continued on the same NSAIDs medications. The NSAIDs dose was kept unchanged throughout the study. All patients were provided with the once-weekly 50 mg dose in the form of etanercept for 24 weeks. After 24 weeks, those patients who had maintained a ASDAS-CRP ≤2.1 during period 1 were randomised to one of three arms (period 2): this arms will receive ETN 25 mg weekly (half dose). In all three arms, the patients continued NSAIDs, and other medications, at the same dose.
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
Patients who entered the study continued on the same NSAIDs medications. The NSAIDs dose was kept unchanged throughout the study. All patients were provided with the once-weekly 50 mg dose in the form of etanercept for 24 weeks. After 24 weeks, those patients who had maintained a ASDAS-CRP ≤2.1 during period 1 were randomised to one of three arms (period 2): this arms will receive placebo weekly. In all three arms, the patients continued NSAIDs, and other medications, at the same dose.
Intervention Type
Drug
Intervention Name(s)
50mg etanercept
Other Intervention Name(s)
50mg Yisaipu®
Intervention Description
Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 50mg per week
Intervention Type
Drug
Intervention Name(s)
25mg etanercept
Other Intervention Name(s)
25mg Yisaipu®
Intervention Description
Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 25mg per week
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
The change of Mardird sonographic enthesis index (MASEI) at 24 weeks
Description
The change of Mardird sonographic enthesis index (MASEI) from week 0 to week24
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Fulfill the 2009 ASAS criteria for axial spondyloarthritis(SpA), and without bilateral more than grave 2 or unilateral more than grave 3 sacroilitis on X ray plan Active disease phase of SpA, defined as BASDAI≥4 or ASDAS≥2.1 Inadequate response to NSAID≥4 week Application of NSAID with stable dose for no less than 2 weeks Stable dose of prenisone for at least four weeks at ≤10mg per day if used at screening, or stop use for at least 4 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 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 Sign the informed consent Exclusion Criteria: Previous application of any biologic agents Allergic to any element of Yisaipu® Intolerance to NASID History of active tubercolosis, or radiographic evidence of present or previous history of pulmonary tubercolosis, or close contact with patients with tubercolosis, or with high risk of infection of tubercolosis such as immune suppression status, or strong positive of PPD skin test with diameter ≥10mm Presence of acute infection or acute onset of chronic infection at screen Invasive fungal infection or conditional infection within 6 months prior to screen Present or history of serious liver disease 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jieruo Gu, Prof.
Organizational Affiliation
Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

Learn more about this trial

A Study of the MASEI in the Treatment of Anti-TNF Blocker to Peripheral Tendonitis in Patients With Spondyloarthritis

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