A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease

ID Number 14-1474

Principal Investigator(s)
James F Marion

Department(s) or Division(s)
Gastroenterology

Description

This is a 40-week open-label extension study designed to evaluate the long-term efficacy, safety, and tolerability of adalimumab.

The purpose of this study is to evaluate the long-term efficacy, safety and tolerability of repeated subcutaneous (under the skin injection) administration of adalimumab in subjects with moderately to severely active Crohn's disease who participated in and successfully completed the M14-115 Study.

Subjects will be evaluated for entry into Study M14-347 at the final study visit (Week 12) of Study M14-115. Subjects must meet all of the inclusion criteria and none of the exclusion criteria to be eligible to participate in this study. The Week 12 visit of Study M14-115 will be considered Week 0 (Baseline) of Study M14-347. All subjects will receive open-label adalimumab 40 mg every other week beginning at Week 0.

Participation in this research study is expected to last approximately 40 weeks and include 6 study visits to the research center.  Subjects will be contacted 70 days after the last dose of study drug for a follow up call.  Unscheduled visits may occur during the study if necessary.

The number of people expected to take part in this research study at this site is 10. The total number of people expected to take part in this research study is 300.



Contact Information
Sari Feldman
(212) 824-7669
sari.feldman@mssm.edu

Recruiting Patients: No