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

Abbott

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: Adalimumab (D2E7)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00055523

M02-403

Details and patient eligibility

About

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)

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind