Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01369355 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI) | PHASE3 | COMPLETED | 1,282 | — | — | Sep 13, 2011 | Oct 1, 2019 | Feb 4, 2025 | 220 | United States, Australia +24 |
Clinical remission at Week 44 was defined as a Crohn's Disease Activity Index (CDAI) score of \<150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). CDAI was assessed by collecting information on 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). A decrease in CDAI over time indicates improvement in disease activity.
| Arm | Type | Description |
|---|---|---|
| 001 | PLACEBO_COMPARATOR | Participants who were responders to Intravenous (IV) infusion of ustekinumab induction will be randomized to receive a single dose of placebo subcutaneously (SC) every 4 weeks (q4w). |
| 002 | EXPERIMENTAL | Participants who were responders to IV ustekinumab induction will be randomized to receive a single dose of ustekinumab 90 milligram (mg) SC every 12 weeks (q12w). |
| 003 | EXPERIMENTAL | Participants who were responders to IV ustekinumab induction will be randomized to receive a single dose of ustekinumab 90 mg SC every 8 weeks (q8w). |
| 004 | EXPERIMENTAL | Participants who were nonresponders to IV ustekinumab induction will receive a single dose of ustekinumab 90 mg SC and one placebo IV at week 0, if then respond will continue to receive one ustekinumab 90 mg SC q8w. |
| 005 | EXPERIMENTAL | Participants who were nonresponders to IV placebo induction will receive a single dose of ustekinumab 130 mg IV and one placebo SC at week 0, if then respond will continue to receive one ustekinumab 90 mg SC at week 8 then q12w. |
| 006 | PLACEBO_COMPARATOR | Participants who were responders to IV placebo induction will receive one dose of placebo SC q4w. |
| Name | Type | Description |
|---|---|---|
| Placebo SC | DRUG | Placebo will be administered subcutaneously. |
| Placebo IV | DRUG | Placebo will be administered as a single Intravenous infusion at week 0. |
| Ustekinumab 90 mg SC q8w | DRUG | Ustekinumab 90 mg will be administered subcutaneously every 8 weeks (q8w) through Week 40. |
| Ustekinumab 130 mg IV | DRUG | Ustekinumab 130 mg will be administered as a single intravenous infusion at week 0. |
| Ustekinumab 90 mg SC q12w | DRUG | Ustekinumab 90 mg will be administered as subcutaneously every 12 weeks (q12w) through Week 40. |
Inclusion Criteria: * Patients who received study agent at the start of study CNTO1275CRD3001 or CNTO1275CRD3002 and completed the Week 8 visit. Exclusion Criteria: * Patients who underwent a Crohn's disease-related surgery since the start of induction study CNTO1275CRD3001 or CNTO1275CRD3002 * Pat...