Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease (BioIBD)
Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring inflammatory bowel diseases, Crohn Disease, Ulcerative Colitis, Infliximab, Adalimumab, Golimumab, Vedolizumab, Ustekinumab, Anti-TNF
Eligibility Criteria
Group 1: Patients with IBD
Inclusion Criteria:
- 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-TNFα, anti-α4β7 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.
Exclusion Criteria:
- 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.
- Ostomy.
- 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-TNFα, anti-α4β7 or anti-p40).
- Refusal to give consent for participation in the study.
Group 2: patients without IBD
Inclusion Criteria:
- Patients not diagnosed with IBD, or other inflammatory, allergic, malignant or autoimmune diseases, where a ileocolonoscopy is performed due to the normal clinical practice.
Exclusion Criteria:
- 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 ileocolonoscopy, or finding of relevant inflammatory alterations in the biopsies obtained during the ileocolonoscopy.
- Treatment with immunomodulators, immunosuppressants, corticosteroids or other drugs that alter the immune system.
- Refusal to give consent for participation in the study.
Sites / Locations
- Hospital Universitario Central de AsturiasRecruiting
- Hospital Universitario Parc TaulíRecruiting
- Hospital Universitario Marqués de ValdecillaRecruiting
- Hospital Público General de TomellosoRecruiting
- Hospital Clínico de SantiagoRecruiting
- Hospital Universitario de FuenlabradaRecruiting
- Hospital Universitario de TorrejónRecruiting
- Hospital de GaldakaoRecruiting
- Hospital General Universitario de AlicanteRecruiting
- Hospital Universitario Reina SofíaRecruiting
- Hospital Universitario DonostiaRecruiting
- Hospital Universitario Dr. Josep Trueta
- Hospital Juan Ramón JiménezRecruiting
- Hospital San JorgeRecruiting
- Hospital Universitario de La PrincesaRecruiting
- Hospital Universitario La PazRecruiting
- Hospital Universitario Virgen del RocíoRecruiting
- Hospital Universitario y Politécnico La Fe
- Hospital Rio HortegaRecruiting
- Hospital Clínico Universitario de ValladolidRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
Patients with treatment
healthy control
Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use) per clinical practice, or adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus) per clinical practice, or golimumab (subcutaneus 50 mg milligram(s)-subcutaneus) per clinical practice, or vedolizumab (infusion 300 mg milligram(s)) per clinical practice or ustekinumab (subcutaneous 90 mg milligram(s)-subcutaneus) per clinical practice