Trial Details
Not recruitingBasic Information
| Clinical ID | c3231 |
|---|---|
| Identifier | NCT01369355 |
| Trial Title | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease |
| 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 | - |
| Country/Region | United States;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Czech Republic;Denmark;France;Germany;Hungary;Iceland;Ireland;Israel;Japan;South Korea;Netherlands;New Zealand;Poland;Russia;Serbia;South Africa;Spain;United Kingdom |
Enrollment Criteria
| Sex Requirement | ALL |
|---|---|
| Age Requirement | ADULT, ELDER, OLDER_ADULT |
Study Design
| Study Type | Interventional |
|---|---|
| Phase | PHASE3 |
Time Information
| Start Date | 2025-04-24 |
|---|---|
| Primary Completion Date | 2017-02-23 |
| Completion Date | - |