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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00195715
• Date of registration: 13/09/2005
• Prospective Registration: No
• Primary sponsor: Abbott
• Public title: Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease
• Scientific title: A Multi Center, Open Label Study of the Human Anti TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's Disease
• Date of first enrolment: September 2004
• Target sample size: 777
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00195715
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Australia, Belgium, Canada, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, South Africa, Spain, Sweden, United Kingdom, United States

Contacts

• Name: Anne Camez, MD
• Affiliation: Abbott

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Biological: Adalimumab

Primary Outcome(s)

Percentage of Subjects Achieving Clinical Remission [Time Frame: Week 156]

Secondary Outcome(s)

Percentage of Subjects Achieving Steroid-free CR-100 [Time Frame: Week 156]

Percentage of Subjects With Lymphoma [Time Frame: Up to 262 weeks of adalimumab treatment]

Percentage of Subjects Achieving Clinical Response 100 (CR-100) [Time Frame: Week 156]

Percentage of Subjects Achieving Steroid-free Clinical Remission [Time Frame: Week 156]

Percentage of Subjects Achieving Clinical Remission [Time Frame: Week 204]

Percentage of Subjects With Hematologic-related Adverse Event [Time Frame: Up to 262 weeks of adalimumab treatment]

Percentage of Subjects With Allergic Reaction-related Adverse Event [Time Frame: Up to 262 weeks of adalimumab treatment]

Percentage of Subjects With Hepatic-related Adverse Event [Time Frame: Up to 262 weeks of adalimumab treatment]

Percentage of Subjects With Infection [Time Frame: Up to 262 weeks of adalimumab treatment]

Percentage of Subjects With Malignancy (Including Lymphoma, Excluding Nonmelanoma Skin Cancer) [Time Frame: Up to 262 weeks of adalimumab treatment]

Percentage of Subjects Achieving Clinical Response 70 (CR-70) [Time Frame: Week 156]

Percentage of Subjects With Fatal Adverse Event [Time Frame: Up to 262 weeks of adalimumab treatment]

Percentage of Subjects With Injection Site Reaction-related Adverse Event [Time Frame: Up to 262 weeks of adalimumab treatment]

Percentage of Subjects With Malignancy (Excluding Nonmelanoma Skin Cancer and Lymphoma) [Time Frame: Up to 262 weeks of adalimumab treatment]

Percentage of Subjects With Nonmelanoma Skin Cancer [Time Frame: Up to 262 weeks of adalimumab treatment]

Percentage of Subjects With Malignancy [Time Frame: Up to 262 weeks of adalimumab treatment]

Percentage of Subjects Achieving Clinical Remission [Time Frame: Week 48]

Percentage of Subjects With Congestive Heart Failure [Time Frame: Up to 262 weeks of adalimumab treatment]

Percentage of Subjects With Opportunistic Infection (Excluding Tuberculosis) [Time Frame: Up to 262 weeks of adalimumab treatment]

Percentage of Subjects Achieving Clinical Remission [Time Frame: Week 108]

Percentage of Subjects With Lupus-like Syndrome [Time Frame: Up to 262 weeks of adalimumab treatment]

Percentage of Subjects With Demyelinating Disease [Time Frame: Up to 262 weeks of adalimumab treatment]

Percentage of Subjects With Fistula Remission [Time Frame: Week 156]

Percentage of Subjects With Serious Infection [Time Frame: Up to 262 weeks of adalimumab treatment]

Secondary ID(s)

M04-690

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/01/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00195715