A Phase 4 interventional study of 50mg Yisaipu and 25mg etanercept in Spondyloarthritis, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-19.
Sponsored by Sun Yat-sen University · Phase 4, Interventional, and Treatment
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.
This randomised controlled trial enrolled adult patients aged 18 years or older diagnosed with non-radiographic axial spondyloarthritis at 3 centres in China. Patients had to fulfil ASAS axial spondyloarthritis criteria but could not fulfil the modified New York radiologic criterion for ankylosing spondylitis,and had to have objective evidence of active inflammation or chronic structral change，such as bone erosion or fat metaplasia in the sacroiliac joints on MRI at screening. Active disease activity was defined as a disease activity score in ASDAS-CRP ≥2.1,or Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] ≥4 on a numerical rating scale of 0-10, and an inadequate response to more than one non-steroidal anti-inflammatory drugs (NSAIDs) for 4 weeks at least, intolerance to NSAIDs, or contraindication for NSAIDs. No change in NSAIDs dose was required from 2 weeks before screening to the end of the study. Dose stability or discontinuation was required for 4 weeks before baseline for concomitant DMARDs or corticosteroids (prednisone or equivalent at a dose of less than 10 mg/day). Chinese herbal medicine, physical therapy, or live (attenuated) vaccine, or intravenous immunoglobulin IgG, was required for discontinuation and wash period for at least 4 weeks. Patients were excluded if they had previously taken or were taking biologic treatment, any biologic Dmards such as IL-6 or CD-20 inhibitors. Patients with latent tuberculosis infection were included only when local guidelines were followed for prophylactic treatment and if treatment was initiated before Yisaipu.
All patients provided written informed consent, and the study protocol was approved by an institutional review board or independent ethics committee at each study site. The study was conducted in accordance with applicable regulations and the ethical principles of Good Clinical Practice as defined by the International Conference on Harmonisation (ICH) and the Declaration of Helsinki.
A randomized envelope was used to enrol all patients at the baseline visit and to randomly assign qualifying patients in a 1:1:1 ratio to receive either blinded Yisaipu 50 mg subcutaneously every week or 25 mg subcutaneously every week or matching placebo at week 24. All study personnel, including the sponsor (with the exception of the Sanshengguojian drug supply management team), investigator, and study site personnel, and the patient remained blinded to treatment throughout the double-blinded period from week 24 through week 72 of the study. Investigational products were provided to maintain blinding.
In the initial open-label period, enrolled patients were given subcutaneous injections of 50 mg Yisaipu every week for 36 weeks. Participants were given the dose of NSAIDs they had been receiving at screening; a dose decrease or discontinuation was allowed when the patients were intolerance to NSAIDs, or contraindication for NSAIDs. Patients who achieved clinical remission, defined as achieving ASDAS inactive or moderate disease (ASDAS score \<2.1) at weeks 24, were randomly assigned to receive either blinded 50mg Yisaipu (continuation arm), 25mg Yisaipu(reduction arm) or matching placebo (withdrawal arm) for 48 weeks during the double-blind period, for a total of 72 weeks of treatment.
During the double-blind period, patients who experienced a flare (defined as an increase in BASDAI ≥2 points compare to the BASDAI score when randomization) were allocate to termination of this trial.
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's enrollment of 150 is above the median of 92 across 349 interventional studies indexed under Spondylitis.
Browse Spondylitis studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 50mg per week, Subcutaneous injection
Drug: 50mg Yisaipu
Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injectio, 25mg per week, Subcutaneous injection
Drug: 25mg etanercept
Placebo, Subcutaneous injection per week
Drug: Placebo
Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 50mg per week
Also known as: 50mg entanercept(Yisaipu)
Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 25mg per week
Also known as: 25mg entanercept(Yisaipu)
The injection method and frequency of placebo is the same as the other arms.
Also known as: placebo arm
proportion of patients achieving ASDAS<2.1
in the groups given 50 mg Yisaipu, 25mg Yisaipu compared to placebo in the double-blind period
Time frame: 72 week
proportion of patients achieving ASDAS<1.3
in the groups given 50 mg Yisaipu, 25mg Yisaipu compared to placebo in the double-blind period
Time frame: 72 weeks
proportion of ASDAS major improvement
in the groups given 50 mg Yisaipu, 25mg Yisaipu compared to placebo in the double-blind period
Time frame: 72 weeks
proportion of ASDAS clinically important improvement
in the groups given 50 mg Yisaipu, 25mg Yisaipu compared to placebo in the double-blind period
Time frame: 72 weeks
ASAS 20
in the groups given 50 mg Yisaipu, 25mg Yisaipu compared to placebo in the double-blind period
Time frame: 72 weeks
ASAS 40
in the groups given 50 mg Yisaipu, 25mg Yisaipu compared to placebo in the double-blind period
Time frame: 72 weeks
ASAS5/6
in the groups given 50 mg Yisaipu, 25mg Yisaipu compared to placebo in the double-blind period
Time frame: 72 weeks
ASAS PR
in the groups given 50 mg Yisaipu, 25mg Yisaipu compared to placebo in the double-blind period
Time frame: 72 weeks
BASDAI50
in the groups given 50 mg Yisaipu, 25mg Yisaipu compared to placebo in the double-blind period
Time frame: 72 weeks
BASDAI
in the groups given 50 mg Yisaipu, 25mg Yisaipu compared to placebo in the double-blind period
Time frame: 72 weeks
BASFI
in the groups given 50 mg Yisaipu, 25mg Yisaipu compared to placebo in the double-blind period
Time frame: 72 weeks
BASMI
in the groups given 50 mg Yisaipu, 25mg Yisaipu compared to placebo in the double-blind period
Time frame: 72 weeks
spinal pain score
The unabbreviated scale title is VAS from 0 to 100mm. 100 mm mean the most severe pain
Time frame: 72 weeks
patient global assessment(PGA) score
in the groups given 50 mg Yisaipu, 25mg Yisaipu compared to placebo in the double-blind period
Time frame: 72 weeks
physician global assessment(PhGA) score
in the groups given 50 mg Yisaipu, 25mg Yisaipu compared to placebo in the double-blind period
Time frame: 72 weeks
ESR
in the groups given 50 mg Yisaipu, 25mg Yisaipu compared to placebo in the double-blind period
Time frame: 72 weeks
CRP
in the groups given 50 mg Yisaipu, 25mg Yisaipu compared to placebo in the double-blind period
Time frame: 72 weeks
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sun Yat-sen University