Trial Details
COMPLETEDBasic Information
| Clinical ID | c3890 |
|---|---|
| Identifier | NCT01369355 |
| Trial Title | A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI) |
| Trial URL | Visit Original Page |
Study Information
| Study Results | YES |
|---|---|
| Conditions | Crohn's Disease|Colitis|IBD|Inflammatory Bowel Disease |
| Interventions | DRUG: Placebo SC|DRUG: Placebo IV|DRUG: Ustekinumab 90 mg SC q8w|DRUG: Ustekinumab 130 mg IV|DRUG: Ustekinumab 90 mg SC q12w |
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 | 2011-09-13 |
|---|---|
| Primary Completion Date | 2015-06-10 |
| Completion Date | 2019-10-01 |