At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 208 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Golimumab 2mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFα Monoclonal Antibody, Administered Intravenously, in Subjects With Active Ankylosing Spondylitis
In Brief
A Phase 3 clinical trial evaluating Placebo and Golimumab for Ankylosing Spondylitis. Completed, enrolled 208 participants across 45 sites in 9 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy of intravenously (administration of a fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants with active ankylosing spondylitis (chronic inflammatory disease of unknown etiology that involves the sacroiliac joints, and often the axial skeleton, entheses, and peripheral joints).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnkylosing Spondylitis
CountriesAustralia, Canada, Germany, Mexico, Poland, Russia, South Korea, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 2014
Enrollment StartSep 2014
Primary CompletionDec 2015
Study CompletionOct 2016
TodayJul 2026
First PostedJul 10, 2014
Enrollment StartSep 3, 2014
Primary CompletionDec 15, 2015
Study CompletionOct 11, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.0 years ago
Interventions
Placebodrug
Participants will receive matching placebo.
Golimumabdrug
Participants will receive 2mg/kg of intravenous infusions of golimumab .