CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 315 enrolled
Drug / intervention
adalimumab (D2E7) +1 morebiological
Likely dose
Adalimumab 40 mg subcutaneously every other weekAI-extracted
Key inclusion· 5
  • ✓Age ≥18 years
  • ✓Meet Modified New York Criteria definition of ankylosing spondylitis
  • ✓Active ankylosing spondylitis by protocol-specified criteria
  • ✓Inadequate response or intolerance to at least one NSAID
Key exclusion· 9
  • ✕Active tuberculosis, listeriosis, or hepatitis B, or any history of hepatitis C
  • ✕History of demyelinating disease or multiple sclerosis
  • ✕History of cancer or lymphoproliferative disease
  • ✕Previous anti-TNF therapy

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

Search/NCT00085644
NCT00085644Phase 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 Jun 16, 2004·Updated Apr 21, 2011

In Brief

A Phase 3 clinical trial evaluating adalimumab (D2E7) and placebo for Ankylosing Spondylitis. Completed, enrolled 315 participants across 22 sites.

Detailed Summary

The objective of this study was to evaluate the safety and efficacy of adalimumab 40 mg given every other week (eow) in subjects with active ankylosing spondylitis (AS) who have had an inadequate response to, or who are intolerant to, treatment with at least 1 nonsteroidal anti-inflammatory drug (NSAID) and who may have also failed treatment with at least 1 disease-modifying antirheumatic drug (DMARD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnkylosing Spondylitis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 16, 2004
Enrollment StartJan 1, 2004
Primary CompletionDec 1, 2004
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 22.0 years ago

Interventions

adalimumab (D2E7)biological

Adalimumab 40 mg every other week, subcutaneous

placebobiological

Placebo every other week, subcutaneous