Trial Details

Not Recruiting
Basic Information
Clinical ID c2937
Identifier EUCTR2015-001410-10-ES
Trial Title Anti-TNF discontinuation in patients with inflammatory bowel disease: Multicentre, prospective, randomized clinical trial and economic evaluation - EXIT
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions Inflammatory bowel disease MedDRA version: 19.0_Level: LLT_Classification code 10021973_Term: Inflammatory bowel disease NOS_System Organ Class: 100000004856_;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Interventions Pharmaceutical Form: Infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intravenous use Pharmaceutical Form: Injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Subcutaneous use
Participant Information
Sponsor Fundación de Investigación Biomédica Hospital Universitario de la Princesa
City -
Country/Region Spain
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement -
Study Design
Study Type Interventional clinical trial of medicinal product
Phase PHASE4
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -