NCT01674413 - Calprotectin-Directed Humira® Maintenance Therapy (CADHUM) | Biotech Hunter

Timeline

Start Date

October 31, 2013

Primary Completion Date

March 31, 2016

Study Completion Date

March 31, 2016

Conditions

Crohn's Disease

Interventions

DRUG

Adalimumab

Adalimumab 40 mg q 2 weeks, with placebo loading of 3 syringes/1 syringe at Weeks 0/2, 12/14, 24/26, and 36/38

DRUG

Adalimumab PRN

"160 mg/80 mg Adalimumab at Weeks 0 and 2, followed by 1 syringe SC placebo q 2 weeks (except at Weeks 12/14, 24/26, and 36/38), with~* PRNLOADing of 160 mg/80 mg Adalimumab at Weeks 12/14, 24/26, or 36/38 if most recent FCP is ≥167 mcg/gram of stool,~* Or, placebo loading of 4 syringes/2 syringes at Weeks 12/14, 24/26, and 36/38 if most recent FCP is \< 167 mcg/gram of stool."

DRUG

Placebo

1 syringe of placebo SC q 2 weeks, with additional placebo loading of 3 syringes/1 syringe at Weeks 0/2, 12/14, 24/26, and 36/38 Weeks.

Trial Locations (1)

48109

University of Michigan Health System, Ann Arbor