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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

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

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

NCT ID

NCT02960035

First Posted

October 6, 2016

Last Updated

December 17, 2019

Sponsor

Sun Yat-sen University

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

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

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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