Overview

This trial is active, not recruiting.

Condition spondyloarthritis
Treatments etanercept, etanercept (half dose), placebo
Phase phase 4
Sponsor Sun Yat-sen University
Start date July 2014
End date December 2016
Trial size 180 participants
Trial identifier NCT02364479, [2013]2-21

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 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 180 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 50mg per week, Subcutaneous injection
etanercept Yisaipu®
Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 50mg per week
(Experimental)
Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injectio, 25mg per week, Subcutaneous injection
etanercept (half dose) Yisaipu®
Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 25mg per week
(Placebo Comparator)
placebo, Subcutaneous injection per week
placebo

Primary Outcomes

Measure
proportion of patients achieving ASDAS<2.1 in Yisaipu® full-dose group
time frame: 48 week

Secondary Outcomes

Measure
proportion of patients achieving ASDAS<2.1 in Yisaipu® half-dose group
time frame: 48 week

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

Official title Treatment of Active Axial Spondyloarthritis by Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection: a Randomized, Double-blind, Multicentral Clinical Trial to Investigate the Efficacy and Safety of Yisaipu®
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Sun Yat-sen University.