CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 304 enrolled
Drug / intervention
adalimumabbiological
Likely dose
Adalimumab: 160 mg loading dose, 80 mg at week 2, 40 mg every other weekAI-extracted
Key inclusion· 5
  • ✓Age 18 years or older
  • ✓Moderate to severe Crohn's disease diagnosed >16 weeks prior, with CDAI >220 or HBI ≥7
  • ✓Disease refractory to optimal conventional therapy (5-ASA, glucocorticoids, azathioprine, 6-MP, MTX)
  • ✓Prior infliximab therapy failure, including primary non-responders
Key exclusion· 6
  • ✕History of cancer (except non-melanoma skin and cervical cancer)
  • ✕History of opportunistic infections, CNS demyelinating disease, chronic viral hepatitis, or untreated tuberculosis
  • ✕Prior exposure to natalizumab (Tysabri)
  • ✕Investigational agent use within 30 days or 5 half-lives prior to screening (whichever longer)

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

Search/NCT00427921
NCT00427921Phase 3Completed
CompareCT.gov

A Multicentre, Open Label, Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)

Abbott·interventional·Posted Jan 29, 2007·Updated Nov 20, 2009

In Brief

A Phase 3 clinical trial evaluating adalimumab for Crohn's Disease. Completed, enrolled 304 participants across 1 site.

Detailed Summary

To make adalimumab available to subjects suffering from moderately to severely active Crohn's Disease (CD) and to expand the safety information on adalimumab. The study also assessed changes in Patient Reported Outcome Measures from baseline.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 29, 2007
Enrollment StartJan 1, 2007
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 19.4 years ago

Interventions

adalimumabbiological

160 mg loading dose, 80 mg at week 2, 40 mg every other week