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Ankylosing SpondylitisPhase 3NCT04345458

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

A Phase 3 study testing prefilled liquid etanercept(Yisaipu) and lyophilized etanercept powder(Yisaipu) in people with Ankylosing Spondylitis, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
prefilled liquid etanercept(Yisaipu) and lyophilized etanercept powder(Yisaipu)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
640 participants
Where
1 siteChina
Study dates
6 Mar 2014to 20 Jul 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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
  • History of active tubercolosis, or radiographic evidence of present or previous history of pulmonary tubercolosis
  • close contact with patients with tubercolosis, or with high risk of infection of tubercolosis such as immune suppression status
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Chinese PLA General Hospital clinical trial center

    Beijing, Beijing Municipality, 100853

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
prefilled liquid etanercept(Yisaipu), lyophilized etanercept powder(Yisaipu)
Keywords
prefilled liquid etanercept, lyophilized etanercept powder, ankylosing spondylitis
Medical subject headings
Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • prefilled liquid etanercept(Yisaipu)Drug

  • lyophilized etanercept powder(Yisaipu)Drug

Study groups in NCT04345458
Study groupRoleWhat they receive
group IExperimentaltwice weekly 25 mg prefilled liquid etanercept
Receives: Drug: prefilled liquid etanercept(Yisaipu)
group IIExperimentalonce weekly 50 mg prefilled liquid etanercept
Receives: Drug: prefilled liquid etanercept(Yisaipu)
group IIIActive comparator25 mg twice weekly lyophilized etanercept powder
Receives: Drug: lyophilized etanercept powder(Yisaipu)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the proportion of patients who achieved ASAS20

    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.

    Measured: at week 24

Secondary outcomes (12)

  1. the proportion of patients who achieved ASAS40, ASAS partial remission

    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.

    Measured: at weeks 12 and 24

  2. the proportion of patients who achieved ASAS 5/6

    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

    Measured: at weeks 12 and 24

  3. the proportion of patients who achieved the ASDAS clinically important and major improvement and inactive disease

    Measured: at weeks 12 and 24

  4. the proportion of patients who achieved BASDAI50

    Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) BASDAI50 was defined as a 50% or greater improvement versus the baseline BASDAI.

    Measured: at weeks 12 and 24

  5. the proportion of patients who achieved improvement in BASDAI

    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)].

    Measured: at weeks 12 and 24

  6. the proportion of patients who achieved improvement in BASFI

    Bath AS Function Index (BASFI)

    Measured: at weeks 12 and 24

  7. the proportion of patients who achieved improvement in BASMI scores

    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.

    Measured: at weeks 12 and 24

  8. the proportion of patients who achieved improvement in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)

    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.

    Measured: at weeks 12 and 24

  9. the proportion of patients who achieved improvement in nocturnal back pain and total back pain VAS

    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.

    Measured: at weeks 12 and 24

  10. the proportion of patients who achieved improvement in patient global assessment and physician global assessment

    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 .

    Measured: at weeks 12 and 24

  11. the proportion of patients who achieved improvement in number of swollen joints and number of tender joints

    Measured: at weeks 12 and 24

  12. the proportion of patients who achieved improvement in ESR and CRP

    Measured: at weeks 12 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2020
  2. Study start6 Mar 2014
  3. Primary completion13 Jul 2015
  4. Study completion20 Jul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
640 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04345458
Sponsor's protocol ID
C301S-AS III
Status last verified
Apr 2020
First submitted
3 Apr 2020
Last updated
14 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zhao D, He D, Bi L, Wu H, Liu Y, Wu Z, Li Y, Wang G, Li X, Bao C, Jiang L, Zhang Z, Xiao W, Tong G, Wang D, Huang F. Safety and Efficacy of Prefilled Liquid Etanercept-Biosimilar Yisaipu for Active Ankylosing Spondylitis: A Multi-Center Phase III Trial. Rheumatol Ther. 2021 Mar;8(1):361-374. doi: 10.1007/s40744-021-00276-1. Epub 2021 Feb 9.

    PubMed 33559842

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing prefilled liquid etanercept(Yisaipu) and lyophilized etanercept powder(Yisaipu) in people with Ankylosing Spondylitis, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the proportion of patients who achieved ASAS20 (time frame: at week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04345458, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.

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