2025-520632-42-00招募中3 期
Evaluation of the efficacy and safety of bimekizumab (BZK) or adalimumab (ADA) in the treatment of anterior chest wall pain associated with active axial spondyloarthritis refractory to NSAIDs with hypothesis of superiority of bimekizumab. Randomized, open-label, in parallel arms, head to head trial (ThoracSPA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 28
- 主要终点
- The primary endpoint will be the ASAS40 response (Spondyloarthritis international Society 40% response) at the 6-month visit. ASAS40 indicates a ≥ 40% improvement in 3 of the 4 domains (BASFI, patient global assessment of disease activity, total spine pain and inflammation (Morning stiffness)
研究概览
简要总结
The primary objective is to demonstrate the superiority of BKZ (dual inhibition of IL-17A and IL-17F) on the ASAS40 response at 6 months compared to a reference treatment (ADA) in patients with active axial or predominantly axial SpA, bDMARD and/or JAKi naïve, with an inadequate response to NSAIDs, one of the main complaints of which being focused on ACW.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Female or male adult-patients aged between 18 and ≤ 60 years
- •History of inadequate response to at least 2 NSAIDs at a therapeutic dose range for >= 2 weeks each or intolerance to >= 2 NSAIDs for at least 3 months
- •Patient with active disease defined by ASDAS-CRP ≥ 2,1
- •Patient with spontaneous pain of the ACW ≥ 4/10 on NS
- •Patient with tenderness at the pressure of at least one of the four chondro-sternal joints of enthesitis MASES score
- •Stable dose of ongoing drug prescriptions (analgesics, NSAIDs) during the last month
- •Patient with at least one unequivocal inflammatory lesion of the ACW highlighted by MRI and/or ultrasonography and/or scintigraphy and/or CT scan < 6 months at the time of randomization, validated by the investigator of each center (no central reading for inclusion procedure)
- •Patient having read and understood the information letter and signed the consent form
- •Patient affiliated with, or beneficiary of a social security (health insurance) category
- •Women of childbearing potential (in accordance with CTCG recommendations, a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile): - with effective contraception (Cf. CTCG recommendations) (progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide) since 1 month, during treatment and for 5 months after cessation of ADA and BKZ treatments and, - a negative blood pregnancy test by b-HCG at inclusion
- •Women permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy)
- •Postmenopausal women: In accordance with CTCG recommendations, a postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- •Patient having an established diagnosis by a rheumatologist of axial or predominantly axial SpA with or without psoriasis fulfilling the 2009 ASAS classification criteria
- •SpA evolving > 3 months
- •bDMARD and JAKi naïve
排除标准
- •Pregnant woman;
- •One of the pre-biotherapy assessment not respected (viral serology, oral health consultation, evaluation of active or inactive (“latent”) tuberculosis infection, …).
- •Patient with contraindication to BIMZELX® 160 mg, solution for injection in pre-filled syringe or pre-filled pen : -Hypersensitivity to the active substance or to any of the excipients, -Clinically important active infections (e.g. active tuberculosis)
- •Patient with contraindication to adalimumab (HUMIRA or one of its biosimilars (AMGEVITA, IMRALDI, HULIO, IDACIO, YUFLYMA, AMSPARITY, HYRIMOZ, HUKYNDRA) : -Hypersensitivity to the active substance or to any of the excipients, -Active tuberculosis or other severe infections such as sepsis and opportunistic infections, -Moderate to severe heart failure (NYHA classes III/IV).
- •Patient with a contraindication to performing MRI in centers performing MRI for the study
- •Person deprived of liberty by an administrative or judiciary decision or person placed under judicial protection, under guardianship or supervision
- •Patient participating or having participated in a therapeutic drug trial in the 3 months prior to inclusion
- •Woman of childbearing potential not using contraception;
- •Patient with an history of chest trauma and/or chest surgery;
- •Patient with an history of radiotherapy in the anterior thoracic region;
- •Infiltration of a cortisone derivative performed in one or more joints of the ACW during the last 3 months
- •Satisfaction of the 2016 ACR diagnostic criteria of fibromyalgia (Appendix 9);
- •Concomitant inflammatory bowel disease (IBD) (contraindication for IL-17i use);
- •Moderate or severe plaque psoriasis requiring higher doses of ADA or BKZ;
- •Analgesic treatment with strong opioids (WHO level III) with an average daily dose > 30 mg/day of morphine (or equivalent)
研究组 & 干预措施
Bimzelx 160 mg solution for injection in pre-filled syringe
Test
干预措施: Bimzelx 160 mg solution for injection in pre-filled syringe (Drug)
ADALIMUMAB
Comparator
干预措施: ADALIMUMAB (Drug)
结局指标
主要结局
The primary endpoint will be the ASAS40 response (Spondyloarthritis international Society 40% response) at the 6-month visit. ASAS40 indicates a ≥ 40% improvement in 3 of the 4 domains (BASFI, patient global assessment of disease activity, total spine pain and inflammation (Morning stiffness)
The primary endpoint will be the ASAS40 response (Spondyloarthritis international Society 40% response) at the 6-month visit. ASAS40 indicates a ≥ 40% improvement in 3 of the 4 domains (BASFI, patient global assessment of disease activity, total spine pain and inflammation (Morning stiffness)
次要结局
- The endpoint will be the average spontaneous ACW pain (measured on a NS) between baseline and the 6-month visit using repetitive self-evaluations of pain collected every week at different day times (dedicaded digital tool).
研究者
PICOCHE
Scientific
Centre Hospitalier Universitaire Rouen
研究点 (28)
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