2025-523551-54-00招募中4 期
Arthritis interception with Guselkumab in subclinical psoriatic arthritis patients in clinical transition from skin to joint disease: a randomized clinical trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- The percentage of patients with subclinical PsA who achieve resolution of arthralgia (defined as VAS pain ≤ 1/10 and TJC ≤ 1/10) together with the effect of guselkumab on objectively quantified synovio-entheseal inflammation, as co-primary objective endpoint evaluated using the UPsA activity activity Score [Timepoint: Week 24].
研究概览
简要总结
To determine whether treatment leads to clinical and ultrasonographic improvement in patients with subclinical PsA by Week 24, defined as the proportion of subclinical PsA patients who, at Week 24, achieve: (a) resolution of arthralgia, defined as VAS pain ≤ 1/10 and Tender Joint Count (TJC) ≤ 1/10, and/or (b) a measurable and significant improvement in synovio-entheseal inflammation, assessed through the UPsA Activity Score compared with baseline.
研究设计
- 分配方式
- Randomized
- 主要目的
- Arrest
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Adult ≥ 18 years of age.
- •Subject must be able to understand and adhere to all protocol requirements and must voluntarily sign and date an informed consent.
- •Subjects are willing and able to comply with procedures required in this protocol.
- •Presence of current from moderate to severe skin psoriasis (PASI≥10) or mild psoriasis (PASI≤10) with the involvement of sensitive area (face, palms, soles, nails, and genital area) diagnosed by a dermatologist with experience in the management of psoriatic disease.
- •Absence of clinical signs of active arthritis, dactylitis, enthesitis and inflammatory back pain at enrolment.
- •Absence of systemic treatment for psoriasis (csDMARDs and/or bDMARDs and/or tsDMARDs treatment) in the last 6 months.
- •The presence of peripheral arthralgia clinically suspected for subclinical PsA (definition in Appendix A)
- •The Presence of at least 2 out of the following 4 sonographic lesions of subclinical inflammation or structural damage suspicious for a psoriatic musculoskeletal inflammation: (i) articular synovitis GS≥ 2 in at least 2 joints; (ii) tenosynovitis GS≥ 1 in at least 2 sites; (iii) active enthesitis in at least one site; (iv) entheseal erosion in at least one site. Ultrasound findings suggestive of subclinical PsA shall be submitted for centralized assessment and independently reviewed by two readers Sonographic Analysis Protocol The sonographic examination will preferably be performed on the same day as the clinical assessment; however, a delay of up to 72 hours from the clinical evaluation will be tolerated. The ultrasound assessment will be conducted blinded to the clinical examination and focused in a longitudinal and transverse scan of 42 regions encompassing the following: metacarpophalangeal, proximal and distal interphalangeal joints of the hands, wrists, knees, metatarsophalangeal joints, 12 entheses (Achilles, quadriceps, proximal and distal patellar, plantar aponeurosis and common extensor tendon entheses), the 2 retro-calcaneal bursae and 32 tendons (extensor digitorum tendons of the hands, flexor digitorum tendons of the hands and extensor tendon compartments of the wrist). The sites to be scanned and sonographic definitions of the lesions (i.e., synovitis, tenosynovitis, enthesitis, peritenon extensor tendon inflammation and bursitis) and damage lesions (i.e., joint erosions, entheseal erosions, enthesophytes and articular osteoproliferation) will be defined according to the OMERACT and EULAR definitions (Appendix B).
排除标准
- •Contraindication to start a new bDMARD treatment course.
- •Fulfilment of CASPAR criteria for PsA.
- •Subjects with a history of cancer within the past 5 years, as well as those with any current or suspected malignancy at the time of enrollment.
- •Known hypersensitivity or allergy to Guselkumab or to any component of the investigational medicinal product, including excipients.
- •Treatment with systemic treatment (csDMARDs or bDMARDs or tsDMARDs) and steroid injection in the 6 months previous enrolment.
- •Has previously received treatment with an IL-23 inhibitor
- •Patients with dementia or an altered mental status, which would preclude the understanding and rendering of informed consent;
- •For women of childbearing potential*: pregnancy status, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 3- months after study completion; *A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- •Known immunodeficiency or patients immunocompromised to an extent that participation in the study would pose and unacceptable risk to the patient;
- •Clinically relevant (chronic or acute) infections, including untreated (latent) tuberculosis, hepatitis B or C or HIV infections;Note: Subjects with a recent acute infection may be enrolled only after full clinical resolution of all signs and symptoms for at least 4 weeks prior to screening.
- •Previous or current diagnosis of PsA.
- •Presence of swollen joints, dactylitis or at clinical examination.
结局指标
主要结局
The percentage of patients with subclinical PsA who achieve resolution of arthralgia (defined as VAS pain ≤ 1/10 and TJC ≤ 1/10) together with the effect of guselkumab on objectively quantified synovio-entheseal inflammation, as co-primary objective endpoint evaluated using the UPsA activity activity Score [Timepoint: Week 24].
The percentage of patients with subclinical PsA who achieve resolution of arthralgia (defined as VAS pain ≤ 1/10 and TJC ≤ 1/10) together with the effect of guselkumab on objectively quantified synovio-entheseal inflammation, as co-primary objective endpoint evaluated using the UPsA activity activity Score [Timepoint: Week 24].
次要结局
- - The change of the synovio-entheseal inflammation score detected by US at w24 and w52
- - The incidence of progression to PsA (defined as CASPAR criteria fulfilment) at w52
- - The percentage of patients who achieved clinical resolution of arthralgia (defined as VAS pain ≤ 1/10 and TJC ≤ 1/10) at w52
- - The percentage of patients who achieve PASI 100 at w24 and w52
- - The change of the Patient Reported Outcomes (e.g. HAQ, BASDAI, DLQI, PsAID).
- - Change in total modified Sharp–van der Heijde (mSvH) score from baseline to Week 52, including erosion score and joint space narrowing components.
研究者
Alen Zabotti
Scientific
Azienda Sanitaria Universitaria Friuli Centrale
研究点 (4)
Loading locations...
相似试验
招募中
4 期
Prospective, multicentre, open-label clinical trial on the effect of GUSelkumab on the resolution of ultrasound-proven ENThEsitis in bDMARD-naïve patients with pSoriatic arthriTisPsoriatic arthritis2024-512459-19-00Universitaetsklinikum Erlangen AöR129
招募中
3 期
A Phase 3 Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Ulcerative Colitis2023-504719-34-00Janssen - Cilag International143
已完成
不适用
Ultrasound-Guided Suprascapular Nerve RFA vs Steroid-Local Anesthetic Injection in Chronic Shoulder PainNCT07302490Nida Koçer Nazlıgül104
招募中
4 期
Investigation of tissue-resident memory T-cells and disease MEMory in psoriasis during GUSelkumab treatment. The GUSMEM study.Psoriasis vulgaris2023-503776-25-00Aarhus University Hospital15
招募中
3 期
Clinical and ultrasound assessment of the therapeutic response to ixekizumab in psoriatic arthritis dactlylitis; a multicentre, parallel-groups, randomised controlled trial2022-503119-40-00Azienda Ospedaliera Ordine Mauriziano Di Torino60