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

Browse trials for

• Spondylitis 623
• Spondylarthritis 597
• Spondylitis, Ankylosing 498

Keywords

• prefilled liquid etanercept
• lyophilized etanercept powder
• ankylosing spondylitis

Spondylitis

623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.

This study's enrollment of 640 is above the median of 92 across 349 interventional studies indexed under Spondylitis.

Lead sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. is the lead sponsor of 56 studies on the registry; 21 are open to participants now.

Study arms

• 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)

Interventions

• Drugprefilled liquid etanercept(Yisaipu)
• Druglyophilized etanercept powder(Yisaipu)

Primary outcomes

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.

   Time frame: at week 24

Secondary outcomes

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.

   Time frame: 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

   Time frame: at weeks 12 and 24

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

   Time frame: 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.

   Time frame: 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 \[1+2+3+4+0.5(5+6)\].

   Time frame: at weeks 12 and 24

6. the proportion of patients who achieved improvement in BASFI

   Bath AS Function Index (BASFI)

   Time frame: 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.

   Time frame: 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.

   Time frame: 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.

   Time frame: 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 .

    Time frame: at weeks 12 and 24

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

    Time frame: at weeks 12 and 24

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

    Time frame: at weeks 12 and 24

Other outcomes

1. AEs

   To assesse the safety

   Time frame: at weeks 2, 4, 8, 12, 16, 20 and 24

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 ↗

Individual participant data

Plan to share: Undecided