Treatment of Axial Spondyloarthritis by Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein

NCT02364479 | Completed Phase 4

• 1 other identifier: [2013]2-21
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy and safety of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc fusion protein injection (Yisaipu®) in the treatment of active axial spondyloarthritis(SpA). The primary purpose is to assess the different situations in maintaining treatment programme in SpA patients with controlled inflammation by Yisaipu®. And the second purpose is to assess the eficacy and safety of Yisaipu® in axial SpAs. The trial will include 150 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 48 weeks. Patients who complete the 72-week therapy or achieve disease-flare criteria during the blind stage would finish the study.

Conditions

Spondyloarthritis

Keywords

relapse; Yisaipu

Outcome Measures

Primary Outcomes (1)

• proportion of patients achieving ASDAS<2.1

  in the groups given 50 mg Yisaipu, 25mg Yisaipu compared to placebo in the double-blind period

  72 week

Secondary Outcomes (16)

• proportion of patients achieving ASDAS<1.3

  72 weeks

• proportion of ASDAS major improvement

  72 weeks

• proportion of ASDAS clinically important improvement

  72 weeks

• ASAS 20

  72 weeks

• ASAS 40

  72 weeks

Study Arms (3)

50mg etanercept

EXPERIMENTAL

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

Drug: 50mg Yisaipu

25mg etanercept

EXPERIMENTAL

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

Drug: 25mg etanercept

Placebo

PLACEBO COMPARATOR

Placebo, Subcutaneous injection per week

Drug: Placebo

Interventions

50mg Yisaipu DRUG

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

Also known as: 50mg entanercept(Yisaipu)

50mg etanercept

25mg etanercept DRUG

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

Also known as: 25mg entanercept(Yisaipu)

25mg etanercept

Placebo DRUG

The injection method and frequency of placebo is the same as the other arms.

Also known as: placebo arm

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• 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, 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.

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, 510060, China

Location

MeSH Terms

Conditions

Spondylarthritis; Recurrence

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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, Professor

  3rd Affiliated Hospital of Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

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: Division of Rheumatology of Third Affiliated Hospital of Sun Yat-sen University

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 18, 2015
• Study Start: February 10, 2014
• Primary Completion: July 28, 2016
• Study Completion: August 28, 2016
• Last Updated: December 19, 2019

Record last verified: 2019-12

Locations

CN (1)