Predictive value of colonic mucosal and synovial tissues profiles for response to JAKs inhibitor in patients affected by ulcerative colitis and concomitant peripheral arthritis - ASPIRE

FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 个研究点目标入组 30 人开始时间: 2021年8月2日最近更新: 2021年8月30日

适应症

试验速览

暂无简介。

•Male and female patients, 18-70 years old
•A moderately-to-severely active UC and a concomitant active peripheral arthritis.
•Indication in clinical practice to start therapy with tofacitinib
•Fertile female who accepts to not get pregnant during the study (see Appendix 1)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 27
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 3

•-Patients not able to provide a written informed consent
•-Any contraindication to tofacitinib, according to RCP:
•- hypersensitivity to the active substance or to any of the excipients;
•- active tuberculosis, serious infections, opportunistic infections, sepsis;
•-pregnancy and breastfeeding;
•-severe hepatic impairment (Child Pugh C);
•-Haemoglobin < 9 g/dl;
•-absolute lymphocyte count <750 cells/mm3 and absolute neutrophil count < 1000/mm3;
•-Concomitant therapy with biological therapies, such as anti TNF-alpha, IL-1R or IL-6R antagonists, anti-CD20 monoclonal antibodies, IL-17 antagonists, IL12-23 antagonists, anti-integrins, or other immunosuppressants such as thiopurines (azatioprina or 6-mercaptopurine), cyclosporine and tacrolimus, according to RCP.

发起方

FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE