Trial Details

Authorised
Basic Information
Clinical ID c5077
Identifier EUCTR2018-002629-51-NL
Trial Title A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn Disease - Patient Optimization With ustekinumab Re-induct
Trial URL Visit Original Page
Study Information
Study Results

NULL
Conditions Crohn Disease MedDRA version: 20.0.Level: PT.Classification code 10011401.Term: Crohn's disease.System Organ Class: 10017947 - Gastrointestinal disorders.;Therapeutic area: Diseases [C] - Immune System Diseases
Interventions Trade Name: STELARAProduct Name: UstekinumabProduct Code: CNTO1275Pharmaceutical Form: Solution for injection in pre-filled syringeINN or Proposed INN: UstekinumabCAS Number: 815610-63-0Current Sponsor code: CNTO1275Other d
Participant Information
Sponsor Janssen-Cilag International NV
City NULL
Country/Region United States;Czech Republic;Spain;Austria;Russia;United Kingdom;Italy;France;Netherlands;Germany;South Korea;Sweden
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement NULL
Study Design
Study Type Interventional clinical trial of medicinal product
Phase PHASE3
Time Information
Start Date NULL
Primary Completion Date NULL
Completion Date NULL