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

December 17, 2019 updated by: Gu Jieruo, Sun Yat-sen University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: etanercept 50mg/week
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.
Drug: 50mg etanercept
Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 50mg per week
Other Names:
  • 50mg Yisaipu®
Experimental: etanercept 25mg/week
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.
Drug: 25mg etanercept
Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 25mg per week
Other Names:
  • 25mg Yisaipu®
Placebo Comparator: PLACEBO
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.
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The change of Mardird sonographic enthesis index (MASEI) at 24 weeks
Time Frame: 24 weeks
The change of Mardird sonographic enthesis index (MASEI) from week 0 to week24
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jieruo Gu, Prof., Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • [2015]2-158

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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