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

Immunologic, genetic and microbiomic predictors of the treatment response for TNFalpha-blocking drugs – prospective follow-up cohort of patients with Crohn’s disease or ulcerative colitis - PROSIBD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001278-13-FI

Enrollment

100

Registered

2016-04-15

Start date

2016-06-08

Completion date

Unknown

Last updated

2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis and Crohn's disease MedDRA version: 19.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: LLT Classification code 10058815 Term: Crohn's disease acute episode System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19

Interventions

Trade Name: Remsima Product Name: Remsima Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To study which genetic, biochemical or inflammatory markers or changes in bowel microbiome predicts the response to infiliximab;Secondary Objective: study a) markers that are related to the immunization to infliximab b) markers that are related to lose of response to infilximab in IBD c) repsonse to biosimilar infilximab 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	—

Measure

Time frame

Main Objective: To study which genetic, biochemical or inflammatory markers or changes in bowel microbiome predicts the response to infiliximab;Secondary Objective: study a) markers that are related to the immunization to infliximab b) markers that are related to lose of response to infilximab in IBD c) repsonse to biosimilar infilximab 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

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

Countries

Finland

Contacts

Public ContactClinic of gastroenterology

Helsinki Unversity Hospital

taina.sipponen@hus.fi+358504286543

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026