Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease

Abbott

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease

Treatments: Biological: Adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00195715

M04-690

Details and patient eligibility

About

To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in and successfully completed Protocol M02-404 or Protocol M04-691.

Enrollment: 777 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject must have successfully completed either the M02-404 (NCT00077779) or M04-691 (NCT00105300) protocol to be eligible for this study
• Diagnosis of Crohn's disease
• Willing and able to give informed consent

Exclusion criteria

• Diagnosis of ulcerative colitis
• Women cannot be pregnant or breastfeeding
• Previous history of listeria infection or untreated tuberculosis
• Previous history of cancer other than successfully treated skin cancer or carcinoma-in-situ of the cervix

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)