Immunologic, genetic and bowel microbes as predictors of the treatment response for TNFalpha-blocking drugs in patients with Crohn’s disease or ulcerative colitis

Phase 1

• Conditions: lcerative colitis and Crohn's disease; MedDRA version: 19.0Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 19.0Level: LLTClassification code 10013099Term: Disease CrohnsSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 19.0Level: LLTClassification code 10058815Term: Crohn's disease acute episodeSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 19.0Level: LLTClassification code 10057035Term: Crohn's ileocolitisSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 19.0Level: LLTClassification code 10011405Term: Crohn's enteritisSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 19.0Level: LLTClassification code 10011406Term: Crohn's ileitisSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 19.0Level: LLTClassification code 10076318Term: Crohn's disease relapseSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 19.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 19.0Level: LLTClassification code 10011402Term: Crohn's disease (colon)System Organ Class: 10017947 - Gastrointestinal disorders

• Registration Number: EUCTR2016-001278-13-FI
• Lead Sponsor: Taina Sipponen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-15
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Adult patients (18-64 years of age) with active ulcerative colitis and Crohn's disease not resonsive or intolerant to conventional steroid or immunosuppressive medication
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 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

pregnancy,
usual exclusion criteria to TNFalpha-blocking agents: active infection, cancer, severe heart insufficiency, tuberculosis, MS-disease. Indication to infliximab is other than active IBD.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To study<br>which genetic, biochemical or inflammatory markers or changes in bowel microbiome predicts the response to infiliximab;Secondary Objective: study<br>a) markers that are related to the immunization to infliximab<br>b) markers that are related to lose of response to infilximab in IBD<br>c) repsonse to biosimilar infilximab<br>d) correlation of serum, tissue and fecal consentration of infliximab with endoscopic, cinical and biomarker (calprotectin) response;Primary end point(s): Clinical and endoscopic induction response to infliximab ;Timepoint(s) of evaluation of this end point: at 3 months after the start of infiximab

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Clinical and endoscopic induction maintenance response;Timepoint(s) of evaluation of this end point: 12months after beginning of infiximab