prediction of response to therapy in inflammatory bowel disease

Phase 1

• Conditions: Inflammatory bowel disease; MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-002925-47-ES
• Lead Sponsor: Fundación de Investigación Biomédica del Hospital Universitario de La Princesa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-16
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

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

Exclusion Criteria

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.
- 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-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified