CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 777 enrolled
Drug / intervention
Adalimumabbiological
Likely dose
Adalimumab 40 mg subcutaneous injection every other week or every weekAI-extracted
Key inclusion· 3
  • ✓Successfully completed either M02-404 (NCT00077779) or M04-691 (NCT00105300) protocol
  • ✓Diagnosis of Crohn's disease
  • ✓Willing and able to give informed consent
Key exclusion· 4
  • ✕Diagnosis of ulcerative colitis
  • ✕Pregnancy or breastfeeding
  • ✕History of listeria infection or untreated tuberculosis
  • ✕Prior cancer other than successfully treated skin cancer or cervical carcinoma-in-situ

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00195715
NCT00195715Phase 3Completed
CompareCT.gov

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

Abbott·interventional·Posted Sep 20, 2005·Updated Jul 12, 2011

In Brief

A Phase 3 clinical trial evaluating Adalimumab for Crohn's Disease. Completed, enrolled 777 participants across 111 sites in 15 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesAustralia, Belgium, Canada, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, South Africa, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartSep 1, 2004
Primary CompletionMar 1, 2006
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 20.8 years ago

Interventions

Adalimumabbiological

Adalimumab 40 mg by subcutaneous injection every other week or every week