CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 82 enrolled
Drug / intervention
adalimumab (D2E7) +1 morebiological
Likely dose
Adalimumab 40 mg subcutaneously every other weekAI-extracted
Key inclusion· 3
  • ✓Age 18 or older
  • ✓Meet Modified New York Criteria for ankylosing spondylitis
  • ✓Inadequate response to or intolerance to one or more NSAIDs
Key exclusion· 2
  • ✕Prior anti-TNF therapy
  • ✕Pregnant, breast-feeding, or considering pregnancy

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

Search/NCT00195819
NCT00195819Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis

Abbott·interventional·Posted Sep 20, 2005·Updated Jun 28, 2011

In Brief

A Phase 3 clinical trial evaluating adalimumab (D2E7) and placebo for Ankylosing Spondylitis. Completed, enrolled 82 participants across 9 sites.

Detailed Summary

The purpose of the study is to assess the safety and clinical efficacy of adalimumab in subjects with active ankylosing spondylitis

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnkylosing Spondylitis
CountriesCanada
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartDec 1, 2003
Primary CompletionOct 1, 2004
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 20.8 years ago

Interventions

adalimumab (D2E7)biological

Adalimumab 40 mg every other week (eow)

placebobiological

Placebo every other week (eow)