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

NCT ID: NCT02960035

Last Updated: 2019-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2018-10-31

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.

Conditions

Spondyloarthropathy

Keywords

Mardird sonographic enthesis index; Spondyloarthropathy; Ultrasonics; Etanercept

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

50mg etanercept

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

25mg etanercept

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

50mg etanercept

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

Intervention Type: DRUG

25mg etanercept

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

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Other Intervention Names

50mg Yisaipu®; 25mg Yisaipu®

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Gu Jieruo

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jieruo Gu, Prof.

Role: STUDY_DIRECTOR

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

Locations

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

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

[2015]2-158

Identifier Type: -

Identifier Source: org_study_id