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

NCT02960035 | Completed Phase 4 DMC

• 1 other identifier: [2015]2-158
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Spondyloarthropathy

Keywords

Mardird sonographic enthesis index; Spondyloarthropathy; Ultrasonics; Etanercept

Outcome Measures

Primary Outcomes (1)

• The change of Mardird sonographic enthesis index (MASEI) at 24 weeks

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

  24 weeks

Study Arms (3)

etanercept 50mg/week

EXPERIMENTAL

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

etanercept 25mg/week

EXPERIMENTAL

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

PLACEBO

PLACEBO COMPARATOR

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

Interventions

50mg etanercept DRUG

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

Also known as: 50mg Yisaipu®

etanercept 50mg/week

25mg etanercept DRUG

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

Also known as: 25mg Yisaipu®

etanercept 25mg/week

placebo DRUG

PLACEBO

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ×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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Spondylarthropathies

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Jieruo Gu, Prof.

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: November 9, 2016
• Study Start: April 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2018
• Last Updated: December 19, 2019

Record last verified: 2019-12

Locations

CN (1)