Trial Details
Not RecruitingBasic Information
| Clinical ID | c5122 |
|---|---|
| Identifier | EUCTR2010-022759-42-DE |
| Trial Title | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease - UNITI 2 |
| Trial URL | Visit Original Page |
Study Information
| Study Results | NULL |
|---|---|
| Conditions | Moderately to severely active Crohn's disease MedDRA version: 17.1.Level: PT.Classification code 10011401.Term: Crohn's disease.System Organ Class: 10017947 - Gastrointestinal disorders.;Therapeutic area: Diseas |
| Interventions | Trade Name: StelaraProduct Name: UstekinumabProduct Code: CNTO1275Pharmaceutical Form: Solution for injectionINN or Proposed INN: UstekinumabCAS Number: 815610-63-0Current Sponsor code: CNTO1275Other descriptive name: N/A<b |
Participant Information
| Sponsor | Janssen-Cilag International N.V. |
|---|---|
| City | NULL |
| Country/Region | United States;Spain;Israel;Russia;Italy;United Kingdom;Hungary;European Union;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Netherlands;Germany;Japan;New Zealand;South Korea |
Enrollment Criteria
| Sex Requirement | NOT SPECIFIED |
|---|---|
| Age Requirement | NULL |
Study Design
| Study Type | Interventional clinical trial of medicinal product |
|---|---|
| Phase | NULL |
Time Information
| Start Date | NULL |
|---|---|
| Primary Completion Date | NULL |
| Completion Date | NULL |