Trial Details
COMPLETEDBasic Information
| Clinical ID | c4267 |
|---|---|
| Identifier | NCT00771667 |
| Trial Title | A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy |
| Trial URL | Visit Original Page |
Study Information
| Study Results | YES |
|---|---|
| Conditions | Crohn's Disease |
| Interventions | DRUG: Placebo (IP)|DRUG: Ustekinumab 1mg/kg (IP)|DRUG: Ustekinumab 3 mg/kg (IP)|DRUG: Ustekinumab 6 mg/kg (IP)|DRUG: Placebo IV - Responder - Placebo SC (MP)|DRUG: Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC (MP)|DRUG: Ustekinumab IV - Responder - Placebo SC (MP)|DRUG: Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP)|DRUG: Ustekinumab IV - Nonresponder - Placebo SC (MP)|DRUG: Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP) |
Participant Information
| Sponsor | Centocor, Inc. |
|---|---|
| City | Mobile |
| Country/Region | United States |
Enrollment Criteria
| Sex Requirement | ALL |
|---|---|
| Age Requirement | ADULT, OLDER_ADULT |
Study Design
| Study Type | INTERVENTIONAL |
|---|---|
| Phase | PHASE2 |
Time Information
| Start Date | 2008-12 |
|---|---|
| Primary Completion Date | 2010-05 |
| Completion Date | 2010-12 |