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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01298492 | A Study To Monitor Long-Term Treatment With PF-00547659 | PHASE2 | COMPLETED | 268 | — | — | Jul 1, 2011 | Jul 27, 2016 | Jun 3, 2021 | 112 | United States, Austria +13 |
| NCT01276509 | Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease | PHASE2 | COMPLETED | 265 | — | — | Apr 6, 2011 | Oct 9, 2015 | Jun 3, 2021 | 137 | United States, Austria +14 |
AEs included adverse drug reactions, illnesses with onset during the study, exacerbation of previous illnesses, clinically significant changes in physical examination findings and abnormal objective test findings (ECG, laboratory). An SAE was defined as any AE at any dose that resulted in death; was life threatening (immediate risk of death); required in-subject hospitalization or prolongation of existing hospitalization; resulted in a persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or resulted in congenital anomaly/birth defect.
Crohn's Disease Activity Index (CDAI) is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. CDAI response rate at week 8 and week 12 was measured between the investigational product group and the placebo group.
| Arm | Type | Description |
|---|---|---|
| Open-Label Treatment | EXPERIMENTAL | Subjects eligible for this study will have completed the 12 week double blind induction period in study A7281006 and will be stratified by responders or non responders based on change in CDAI in that study, without unblinding treatment assignment from study A7281006. Additionally, subjects who have completed study A7281008 |
| Placebo-SC Injection | PLACEBO_COMPARATOR | Placebo delivered SC, 3 doses separated by 4 weeks. |
| Drug Dose level 1- SC injection | EXPERIMENTAL | Drug dose level 1 delivered SC, 3 doses separated by 4 weeks. |
| Drug Dose level 2-SC injection | EXPERIMENTAL | Drug dose level 2 delievered SC, 3 doses separated by 4 weeks. |
| Drug Dose level 3- SC injection | EXPERIMENTAL | Drug dose level 3 delivered SC, 3 doses separated by 4 weeks. |
| Name | Type | Description |
|---|---|---|
| PF-00547659 | DRUG | 75 mg SC once monthly for 72 weeks. Subjects may escalate to 225 mg or de-escalate to 22.5 mg one time. |
| PF-00547659 SC injection | DRUG | Placebo delivered SC, 3 doses separated by 4 weeks |
Inclusion Criteria: * Subjects between 18 and 76 years of age. * Subjects previously enrolled in study A7281006 who have completed the blinded 84 day (12 week) induction period or in study A7281008 who have completed Week 12 and have demonstrated a clinical response as defined by that protocol. Ex...