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A Study of the Use of the Madrid Ultrasound Scoring System in the Treatment of Anti-TNF Blocker to Peripheral Tendonitis in Patients With Spondyloarthritis

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ClinicalTrials.gov Identifier: NCT02960035
Recruitment Status : Completed
First Posted : November 9, 2016
Last Update Posted : November 9, 2016
Sponsor:
Information provided by (Responsible Party):
Gu Jieruo, Sun Yat-sen University

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. 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.

Condition or disease Intervention/treatment Phase
Spondyloarthropathy Drug: etanercept Drug: etanercept (half dose) Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2014
Actual Primary Completion Date : September 2016

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Drug Information available for: Etanercept

Arm Intervention/treatment
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: etanercept
Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 50mg per week
Other Name: 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: etanercept (half dose)
Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 25mg per week
Other Name: 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



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960035


Locations
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China, Guangdong
Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Sponsors and Collaborators
Sun Yat-sen University

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Responsible Party: Gu Jieruo, Prof, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02960035     History of Changes
Other Study ID Numbers: [2015]2-158
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: November 9, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be published on the Journals.

Keywords provided by Gu Jieruo, Sun Yat-sen University:
Mardird sonographic enthesis index
Spondyloarthropathy
Ultrasonics
Etanercept

Additional relevant MeSH terms:
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Spondylarthritis
Tendinopathy
Spondylarthropathies
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Muscular Diseases
Tendon Injuries
Wounds and Injuries
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors