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

Completed · Phase 3

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT00195715

Run by

Abbott

People needed

777

Starts

2004-09-01

Expected to finish

2008-12-01

Last updated by the study team

2011-07-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Site Ref # / Investigator 1895 — Jacksonville, Alabama, United States
• Site Ref # / Investigator 1787 — La Jolla, California, United States
• Site Ref # / Investigator 1902 — Roseville, California, United States
• Site Ref # / Investigator 1824 — San Diego, California, United States
• Site Ref # / Investigator 1891 — San Diego, California, United States
• Site Ref # / Investigator 1860 — Englewood, Colorado, United States
• Site Ref # / Investigator 6178 — Lone Tree, Colorado, United States
• Site Ref # / Investigator 1904 — Wheat Ridge, Colorado, United States
• Site Ref # / Investigator 1858 — Bridgeport, Connecticut, United States
• Site Ref # / Investigator 1827 — Clearwater, Florida, United States
• Site Ref # / Investigator 1883 — Gainesville, Florida, United States
• Site Ref # / Investigator 1909 — Hollywood, Florida, United States
• Site Ref # / Investigator 1884 — Ormond Beach, Florida, United States
• Site Ref # / Investigator 1786 — Winter Park, Florida, United States
• Site Ref # / Investigator 1912 — Atlanta, Georgia, United States
• Site Ref # / Investigator 1878 — Arlington Heights, Illinois, United States
• Site Ref # / Investigator 2534 — Chicago, Illinois, United States
• Site Ref # / Investigator 1823 — Peoria, Illinois, United States
• Site Ref # / Investigator 1885 — Anderson, Indiana, United States
• Site Ref # / Investigator 1900 — Indianapolis, Indiana, United States
• Site Ref # / Investigator 1890 — Indianapolis, Indiana, United States
• Site Ref # / Investigator 1892 — Lexington, Kentucky, United States
• Site Ref # / Investigator 1906 — Metairie, Louisiana, United States
• Site Ref # / Investigator 1881 — Annapolis, Maryland, United States
• Site Ref # / Investigator 1894 — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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