| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01714726 | Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease. | PHASE2 | COMPLETED | 121 | — | — | Feb 1, 2013 | Dec 14, 2016 | May 26, 2021 | 80 | United States, Canada +7 |
A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes subject reported symptoms, physician-assessed signs, and laboratory markers. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity. The CDAI response at Week 8 is defined as either CDAI score of less than (\<)150 or CDAI reduction from baseline of at least 100 points, where baseline was last non-missing observation prior to first administration of the study drug. Modified Intent-to-treat (mITT)population was analysed for this end point, which included all subjects who were randomized and received at least 1 dose of study drug in double-blind period.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | MEDI2070 iv infusion |
| 2 | PLACEBO_COMPARATOR | placebo iv infusion |
| open-label | EXPERIMENTAL | MEDI2070 sc injection; open-label arm is available for all subjects upon completion of first placebo-controlled treatment period |
| Name | Type | Description |
|---|---|---|
| MEDI2070 | DRUG | 1 iv infusion on Week 0 and Week 4 |
| placebo | DRUG | 1 iv infusion on Week 0 and Week 4 |
Inclusion Criteria: * Diagnosed ileal, ileo-colonic, or colonic CD at least 6 months prior to screening. * Men or women age 18 - 65 years at the time of screening. * Moderate-sever active Crohn's Disease (CD), defined by a Crohn's Disease Activity Index (CDAI) score higher or equal 220 and lower or...