Trial Details
COMPLETEDBasic Information
| Clinical ID | c1831 |
|---|---|
| Identifier | NCT01369329 |
| Trial Title | A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1) |
| Trial URL | Visit Original Page |
Study Information
| Study Results | YES |
|---|---|
| Conditions | Crohn's Disease; IBD; Colitis; Inflammatory Bowel Disease |
| Interventions | DRUG: Group 2 ustekinumab 130 mg; DRUG: Group 3: ustekinumab approximately 6 mg/kg; DRUG: Group 1: Placebo |
Participant Information
| Sponsor | Janssen Research & Development, LLC |
|---|---|
| City | Tucson |
| Country/Region | United States |
Enrollment Criteria
| Sex Requirement | ALL |
|---|---|
| Age Requirement | - |
Study Design
| Study Type | INTERVENTIONAL |
|---|---|
| Phase | PHASE3 |
Time Information
| Start Date | 2025-07-11 |
|---|---|
| Primary Completion Date | 2025-06-13 |
| Completion Date | 2025-07-13 |