Trial Details
COMPLETEDBasic Information
| Clinical ID | c3891 |
|---|---|
| Identifier | NCT01369342 |
| Trial Title | A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2) |
| Trial URL | Visit Original Page |
Study Information
| Study Results | YES |
|---|---|
| Conditions | Crohn's Disease|Inflammatory Bowel Disease|IBD|Colitis |
| Interventions | DRUG: Group 1: Placebo|DRUG: Group 2 ustekinumab 130 mg|DRUG: Group 3: ustekinumab approximately 6 mg/kg |
Participant Information
| Sponsor | Janssen Research & Development, LLC |
|---|---|
| City | Tucson |
| Country/Region | United States |
Enrollment Criteria
| Sex Requirement | ALL |
|---|---|
| Age Requirement | ADULT, OLDER_ADULT |
Study Design
| Study Type | INTERVENTIONAL |
|---|---|
| Phase | PHASE3 |
Time Information
| Start Date | 2011-07 |
|---|---|
| Primary Completion Date | 2014-08 |
| Completion Date | 2014-10 |