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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01277666 | A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease | PHASE3 | COMPLETED | 608 | — | — | Dec 20, 2010 | Jul 11, 2013 | Sep 19, 2017 | 219 | United States, Australia +21 |
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. The score was algorithmically derived from the sum of participant reported Crohn's disease symptoms recorded over 7 days and investigator recorded assessments of the participant's condition, laboratory parameters and use of anti-diarrhoeal medication. CDAI score was calculated based on the data collected in the diary card. The total CDAI score ranged from 0 to approximately 600, where higher scores indicate more severe disease. Both participants and investigators made their entries via IVRS each evening before going to bed. Percentage of participants with CDAI response at Week 12 was presented.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | orally administered |
| GSK1605786A 500mg once daily | EXPERIMENTAL | orally administered |
| GSK1605786A 500mg twice daily | EXPERIMENTAL | orally administered |
| Name | Type | Description |
|---|---|---|
| GSK1605786A | DRUG | 500 mg twice daily, administered orally for 12 weeks |
| Placebo | DRUG | Placebo capsules, administered orally for 12 weeks |
Inclusion Criteria: * Male or female subjects aged 18 years or older * Written informed consent * Diagnosis of Crohn's disease for greater than 4 months duration with small bowel and/or colonic involvement * Confirmation of Crohn's disease established by visualisation of the gastrointestinal tract ...