Safety and Efficacy Study of Prefilled Liquid Etanercept(Yisaipu) for Active Ankylosing Spondylitis

April 10, 2020 updated by: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Safety and Efficacy of Prefilled Liquid Etanercept(Yisaipu) for Active Ankylosing Spondylitis on the Basis of NSAID Therapy: A Multicenter Randomized, Double-blind, Parallel Group Phase III Trial

This randomized, double-blind, phase III parallel-group non-inferiority study aimed to investigate the efficacy and safety of prefilled liquid etanercept (Yisaipu) versus lyophilized etanercept powder (Yisaipu) in active ankylosing spondylitis patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study carried out between March 6, 2014 and July 13, 2015 across multiple medical centers in China enrolled adult active ankylosing spondylitis patients aged between 18 and 65 years. Patients were randomized in a 3:1:1 ratio to receive twice weekly 25 mg prefilled liquid etanercept for totally 24 injections (group I) or once weekly 50 mg prefilled liquid etanercept for totally 48 injections (group II), or 25 mg twice weekly lyophilized etanercept powder for totally 48 injections (group III). The primary efficacy outcome was the proportion of patients who achieved ASAS20 at week 24.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
640

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Chinese PLA General Hospital clinical trial center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18-65，male or female
  • Sign the informed consent
  • Fulfill the 1966 AS New York criteria for axial spondyloarthritis(SpA)
  • Active disease phase of SpA, defined as BASDAI≥4 or night back pain≥4 at screening
  • Inadequate response to NSAID≥4 week
  • Application of NSAID with stable dose for no less than 2 weeks at screening
  • Stable dose of prenisone for at least four weeks at ≤10mg per day if used at screening, or stop oral use for at least 4 weeks or stop local injection at least 12 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
  • Stop and receiving washing out for at least 12 week if receiving other biologics or other drug trials
  • 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

Exclusion Criteria:

  • Allergic condition or Allergic to IgG or any element of Yisaipu®
  • Clinical or radiographic evidence of Complete ankylosis of spine
  • Previous receiving TNF-a blockers therapy ≥3 months with poor response

  • Achieve any following tuberculosis criteria

    1. History of active tubercolosis, or radiographic evidence of present or previous history of pulmonary tubercolosis
    2. close contact with patients with tubercolosis, or with high risk of infection of tubercolosis such as immune suppression status
    3. Strong positive of PPD skin test with diameter ≥10mm. at screen or within 3 weeks prior to screen
  • Presence of acute infection or acute onset of chronic infection at screen
  • Invasive fungal infection or conditional infection within 6 months prior to screen
  • HBS-Ag or HBC-Ab positive at screen or history of HBS/HBC infection
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: group I
twice weekly 25 mg prefilled liquid etanercept
Drug: prefilled liquid etanercept(Yisaipu)
Experimental: group II
once weekly 50 mg prefilled liquid etanercept
Drug: prefilled liquid etanercept(Yisaipu)
Active Comparator: group III
25 mg twice weekly lyophilized etanercept powder
Drug: lyophilized etanercept powder(Yisaipu)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the proportion of patients who achieved ASAS20
Time Frame: at week 24
Axial SpondyloArthritis international Society (ASAS) ASAS20 was defined as an improvement of at least 20% in at least three of the following four domains: 1) patient global assessment VAS, 2) nocturnal back pain and total back pain VAS, 3) Bath AS Function Index (BASFI) VAS, and 4) inflammation (mean of intensity and duration of morning stiffness components from the an improvement at least one unit relative to baseline VAS score; no worsening in the remaining fourth domain.
at week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the proportion of patients who achieved ASAS40, ASAS partial remission
Time Frame: at weeks 12 and 24
Axial SpondyloArthritis international Society (ASAS) ASAS40 was defined as improvement of at least 40% in at least three of the four abovementioned domains and an absolute improvement of at least two versus baseline VAS scores and no worsening versus the baseline in the remaining fourth domain. ASAS partial remission was defined as VAS scores ≤2 in each of the four abovementioned domains.
at weeks 12 and 24
the proportion of patients who achieved ASAS 5/6
Time Frame: at weeks 12 and 24
Axial SpondyloArthritis international Society (ASAS) ASAS 5/6 was defined as an improvement of at least 20% in at least five of the following six domains: 1) C-reactive protein (CRP), and 2) spinalmobility (scoliosis) in addition to the four above mentioned domains
at weeks 12 and 24
the proportion of patients who achieved the ASDAS clinically important and major improvement and inactive disease
Time Frame: at weeks 12 and 24
at weeks 12 and 24
the proportion of patients who achieved BASDAI50
Time Frame: at weeks 12 and 24
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) BASDAI50 was defined as a 50% or greater improvement versus the baseline BASDAI.
at weeks 12 and 24
the proportion of patients who achieved improvement in BASDAI
Time Frame: at weeks 12 and 24
It was evaluated with a 6-question questionnaire,including: 1) fatigue; 2)spinal pain; 3) pain and swelling of peripheral joints; 4) pain at entheseal sites; 5) severity of morning stiffness and 6) duration of morning stiffness by using a single-item visual analog scale (VAS), with scores ranging from 0-10 cm. After taking the answer of each question out of 10 , the BASDAI score was calculated by formula 0.2 [1+2+3+4+0.5(5+6)].
at weeks 12 and 24
the proportion of patients who achieved improvement in BASFI
Time Frame: at weeks 12 and 24
Bath AS Function Index (BASFI)
at weeks 12 and 24
the proportion of patients who achieved improvement in BASMI scores
Time Frame: at weeks 12 and 24
The Bath Ankylosing Spondylitis Metrology Index (BASMI) is a combined measure of spinal mobility and hip function.Cervical rotation, tragus-wall distance, lateral lumbar flexion( the distance of the middle fingertip moves on the side of the thigh), anterior lumbar flexion(modified schober) , intermalleolar distance were measured. And according to the measurement result, each score with 0, 1, 2 points was recorded.
at weeks 12 and 24
the proportion of patients who achieved improvement in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
Time Frame: at weeks 12 and 24
The (MASES) index based on 13 entheses. Enthesial sites assessed include the bilateral 1st costochondral joints(L and R), 7th costochondral joints(L and R), posterior superior iliac spines(L and R), anterior superior iliac spines(L and R), iliac crests(L and R), proximal insertion of Achilles tendons(L and R), and the 5th lumbar spinous process.The score of each part with 0 or 1 points was recorded.
at weeks 12 and 24
the proportion of patients who achieved improvement in nocturnal back pain and total back pain VAS
Time Frame: at weeks 12 and 24
Nocturnal back pain and total back pain in the past week was assessed using a single-item visual analog scale (VAS), with scores ranging from 0-10 cm, where 0 represented no pain and 10 represented worst possible pain.
at weeks 12 and 24
the proportion of patients who achieved improvement in patient global assessment and physician global assessment
Time Frame: at weeks 12 and 24
Patient global assessment (PGA,disease activity rated by the patient) was recorded on a VAS from 0 to 10 cm, where 0 represented very good and 10 represented very worse. Physician global assessment (PhGA,disease activity rated by the physician) was recorded on a VAS from 0 to 10 cm, where 0 defined as no disease activity state and 10 defined as most serious disease activity state .
at weeks 12 and 24
the proportion of patients who achieved improvement in number of swollen joints and number of tender joints
Time Frame: at weeks 12 and 24
at weeks 12 and 24
the proportion of patients who achieved improvement in ESR and CRP
Time Frame: at weeks 12 and 24
at weeks 12 and 24

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AEs
Time Frame: at weeks 2, 4, 8, 12, 16, 20 and 24
To assesse the safety
at weeks 2, 4, 8, 12, 16, 20 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 13, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C301S-AS III

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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