CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 158 enrolled
Drug / intervention
Infliximab +2 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Age 18 to 48 years
  • ✓Diagnosis of active axial spondyloarthritis with disease duration ≤3 years
  • ✓Active disease during trial enrollment
  • ✓Limited treatment history for axial spondyloarthritis (must meet certain criteria)
Key exclusion· 5
  • ✕Pregnant, breastfeeding, or intending to become pregnant
  • ✕Substance abuse problem within previous 3 years prior to screening
  • ✕Currently participating in any other clinical study
  • ✕Certain medical conditions and/or recent history of certain medical disorders

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

Search/NCT00844805
NCT00844805Phase 3Completed
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Infliximab as First Line Therapy in Patients With Early Active Axial Spondyloarthritis Trial

Merck Sharp & Dohme LLC·interventional·Posted Feb 16, 2009·Updated Apr 12, 2017

In Brief

A Phase 3 clinical trial evaluating Infliximab, Placebo, and 1 other intervention for Ankylosing Spondylitis and Axial Spondyloarthritis. Completed, enrolled 158 participants.

Detailed Summary

The primary objective of this study was to assess the proportion of participants in the infliximab plus naproxen arm versus the placebo plus naproxen arm, in a population of participants with moderate-to-severe active axial spondyloarthritis and disease duration of ≤3 years, who achieve the Assessment in Ankylosing Spondylitis (ASAS) partial remission criteria.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnkylosing Spondylitis, Axial Spondyloarthritis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 16, 2009
Enrollment StartSep 1, 2009
Primary CompletionApr 1, 2011
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.4 years ago

Interventions

Infliximabdrug

Placebodrug

Naproxendrug