Identification of predictive biomarkers for response to biologic therapies in inflammatory bowel disease by proteomic and mass cytometry approaches

Fundación de Investigación Biomédica del Hospital Universitario de La Princesa0 个研究点目标入组 180 人开始时间: 2018年11月16日最近更新: 2019年2月28日

试验速览

暂无简介。

•Group 1: Patients with IBD
•- Over 18 years.
•- Diagnosis of IBD according to the criteria of the European Crohns and Colitis Organization (ECCO).
•- Have indication of treatment with a biologic drug.
•- Be the first received biologic drug with a given mechanism of action (anti-TNFa, anti-a4ß7 or anti-p40).
•- Have endoscopic activity of IBD within 1 month of starting the biologic treatment (see definitions section: SES-CD = 3 in CD and endoscopic sub-index of May = 2 in UC).
•- In the case of CD, receive the biologic treatment by luminal activity (not perianal).
•- Previous treatments (including corticosteroids and immunosuppressants) are allowed provided that they have been stable for the last 3 months prior to beginning treatment with biologics and that they are maintained at a stable dose for the duration of the study.
•Group 2: patients without IBD
•- Patients not diagnosed with IBD, or other inflammatory, allergic, malignant or autoimmune diseases, where a ilecolonoscopy is performed due to the normal clinical practice.
•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 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•Group 1: Patients with IBD
•- Under 18 years old.
•- Having an immune-mediated disease other than IBD at the baseline visit.
•- Having a neoplasm or an active infection at the time of the baseline visit.
•- Pregnancy or lactation.
•- Alcohol or drug abuse.
•- Abdominal surgery in the last 6 months.
•- Colectomy in patients with UC.
•- Active infection with hepatitis B, C or HIV virus.
•- Indication of biologic treatment for a cause other than IBD.
•- Indication of biologic treatment to prevent postoperative recurrence in CD.
•- Have previously received a biologic drug with the same mechanism of action of the drug indicated by your doctor (anti-TNFa, anti-a4ß7 or anti-p40).
•- Refusal to give consent for participation in the study.
•Group 2: patients without IBD
•- Under 18 years old.
•- Advanced chronic disease or any other pathology that prevents the follow-up of the protocol of this study.
•- Pregnancy or lactation.
•- Active infection with hepatitis B, C or HIV virus.
•- Alcohol or drug abuse.
•- Finding of macroscopic alterations during the ilecolonoscopy, or finding of relevant inflammatory alterations in the biopsies obtained during the ilecolonoscopy.
•- Treatment with immunomodulators, immunosuppressants, corticosteroids or other drugs that alter the immune system.
•- Refusal to give consent for participation in the study.

发起方

Fundación de Investigación Biomédica del Hospital Universitario de La Princesa