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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00055497 | Remission in Subjects With Crohn's Disease, 1 Year Phase | PHASE3 | COMPLETED | 276 | — | — | Aug 1, 2002 | Dec 1, 2008 | Apr 11, 2011 | 43 | United States |
Clinical remission is defined as CDAI score \<150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \>/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Clinical remission is defined as CDAI score \<150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \>/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
| Arm | Type | Description |
|---|---|---|
| Double-blind (DB) adalimumab placebo | PLACEBO_COMPARATOR | Double-blind nonactive matching subcutaneous injection |
| Double-blind adalimumab 40 mg every other week (eow) | EXPERIMENTAL | Double-blind adalimumab 40 mg eow by subcutaneous injection |
| Double-blind adalimumab 40 mg every week (ew) | EXPERIMENTAL | Double-blind adalimumab 40 mg every week by subcutaneous injection |
| Open-label adalimumab 40 mg | EXPERIMENTAL | Open-label adalimumab 40 mg eow or ew by subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| Double-blind (DB) adalimumab placebo | BIOLOGICAL | Double-blind nonactive matching subcutaneous injection |
| DB adalimumab 40 mg eow | BIOLOGICAL | Double-blind adalimumab 40 mg every other week by subcutaneous injection |
| DB adalimumab 40 mg ew | BIOLOGICAL | Double-blind adalimumab 40 mg every week by subcutaneous injection |
| OL adalimumab 40 mg | BIOLOGICAL | Open-label adalimumab every other week or every week by subcutaneous injection |
Inclusion: * Patient must have successfully completed the induction study NCT00055523 * Diagnosis of Crohn's disease * Willing and able to give informed consent Exclusion: * Diagnosis of ulcerative colitis * Pregnancy or breastfeeding * Previous use of infliximab or other anti-TNF antagonists * P...