A Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Purpose of the study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease when compared to placebo (an inactive substance)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Adalimumab; Antibodies

Criteria

Inclusion:

• Diagnosis of Crohn's disease

• CDAI score at baseline of between 220 and 450

• Normal laboratory parameters

• Willing and able to give informed consent

Exclusion:

• Diagnosis of ulcerative colitis

• Women cannot be pregnant or breastfeeding

• No previous use of infliximab or other anti-TNF antagonists

• No previous history of tuberculosis or listeria infection

• No previous history of cancer other than successfully treated skin cancer