drugset / Trial / NCT01674413

Calprotectin-Directed Humira® Maintenance Therapy (CADHUM)

NCT01674413

Phase 3 Withdrawn Peter Higgins AbbVie · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a study that invites adults with Crohn's disease and have been responding well to Adalimumab (Humira ®) for at least 6 months. Patients frequently discontinue maintenance medications in Crohn's disease, particularly when in remission. Patients want to know that they truly need to take a medication, yet they don't want to have flares. The purpose of this study is to see that if we monitor the patient, along with looking at changes in their stool samples, we can safely stop the maintenance medication Adalimumab for up to 48 weeks, or add as-needed dosing only, and keep them in remission.

Timeline

Start
2013-10
Primary completion
2016-03
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adalimumab Monoclonal antibody 40 mg
Comparator Adalimumab Monoclonal antibody 80 mg
Comparator Adalimumab Monoclonal antibody 160 mg

Indications