CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 213 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Golimumab 50 mgfrom 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.

Search/NCT01248793
NCT01248793Phase 3Completed

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Golimumab in the Treatment of Chinese Subjects With Ankylosing Spondylitis

Centocor, Inc.·interventional·Posted Nov 25, 2010·Updated Mar 20, 2013

In Brief

A Phase 3 clinical trial evaluating Placebo, Golimumab, and 1 other intervention for Ankylosing Spondylitis. Completed, enrolled 213 participants across 7 sites.

Detailed Summary

The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with ankylosing spondylitis

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 25, 2010
Enrollment StartOct 1, 2010
Primary CompletionMay 1, 2011
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 15.6 years ago

Interventions

Placebodrug

Placebo subcutaneous (SC) injections at Weeks 0, 4, 8, 12, 16, and 20

Golimumabdrug

Golimumab 50 mg SC injection every 4 weeks for 48 weeks

Golimumab (placebo group)drug

Golimumab with early escape at Week 16, 50 mg SC injections at Week 24 and every 4 weeks thereafter through Week 48