2024-512459-19-00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 arthriTis
Universitaetsklinikum Erlangen AöR4 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2024年6月11日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 129
- 试验地点
- 4
- 主要终点
- Resolution of enthesitis (SPARCC = 0) at week 24
研究概览
简要总结
To assess the effect of Guselkumab on the resolution of clinical and ultrasound-confirmed enthesitis in patients with PsA
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Written informed consent obtained from the subject
- •Adult male or female subject; age ≥ 18 years
- •Diagnosis of PsA according to CASPAR criteria
- •SPARCC Enthesitis ≥ 1 at baseline
- •bDMARD naïve
- •Failure or adverse reaction to at least one csDMARD or indication to start systemic therapy with Guselkumab due to moderate-to-severe plaques psoriasis
- •PD Grade ≥ 2 for at least 1 affected enthesis at baseline or PD Grade ≥ 1 for at least 2 affected entheses at baseline
排除标准
- •Diagnosis of any other rheumatological/ immunological disease such as rheumatoid arthritis, SLE, PSS, MCTD, Behcet syndrome or GPA
- •Concomitant florid active immune mediated disease (e.g. autoimmune hepatitis) that is untreated and/or requires immunosuppressive treatment
- •History of ongoing, chronic or recurrent infectious disease (Infection with HIV, HBV or HCV) or evidence of tuberculosis infection as defined by a positive QuantiFERON Tb-Gold test. If presence of latent tuberculosis is established then treatment according to local country guidelines must have been initiated but patient cannot take part in the study
- •History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed), treated or untreated within the past 5 years prior to enrolment
- •History or evidence of ongoing alcohol or drug abuse, within the last six months prior to enrolment
- •Contraindication for Guselkumab treatment according to their SmPCs
- •Use of any inadmissible medication (e.g. drugs under development or bDMARDs approved for PsA other than Guselkumab) List of admitted drugs alongside IMP: • csDMARD - Leflunomide (e.g. Arava), Sulfasalazine (e.g. Azulfidine RA, Pleon RA), Methotrexate (e.g. Lantarel, Metex) and/or • systemic glucocorticoids with a stable dose of ≤ 7,5 mg of prednisolone equivalents within the last 12 weeks of screening
- •Nursing mother or pregnant woman
结局指标
主要结局
Resolution of enthesitis (SPARCC = 0) at week 24
Resolution of enthesitis (SPARCC = 0) at week 24
次要结局
未报告次要终点
研究者
Prof. Dr. med. Georg Schett
Scientific
Universitaetsklinikum Erlangen AöR
研究点 (4)
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