CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 356 enrolled
Drug / intervention
golimumab +2 morebiological
Likely dose
Golimumab 50–100 mg subcutaneously every 4 weeksAI-extracted
Key inclusion· 3
  • ✓Confirmed diagnosis of ankylosing spondylitis (AS) by modified New York criteria for ≥3 months before study drug
  • ✓Active disease: BASDAI score ≥4 AND total back pain score ≥4 (0–10 scale)
  • ✓Inadequate response to 3 months of continuous maximum-dose NSAID therapy, or intolerance/contraindication to NSAIDs
Key exclusion· 2
  • ✕Complete ankylosis (fusion) of the spine
  • ✕Prior treatment with any biologic anti-TNF agent (infliximab, etanercept, adalimumab)

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

Search/NCT00265083
NCT00265083Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalpha MonoclonalAntibody, Administered Subcutaneously, in Subjects With Active Ankylosing Spondylitis

Centocor, Inc.·interventional·Posted Dec 14, 2005·Updated Jul 19, 2013

In Brief

A Phase 3 clinical trial evaluating golimumab and Golimumab (CNTO 148); placebo for Spondylitis, Ankylosing. Completed, enrolled 356 participants across 39 sites in 9 countries.

Detailed Summary

The purpose of this study is to evaluate the safety and efficacy of subcutaneous injections (under the skin) of golimumab for the treatment of active ankylosing spondylitis \[AS(arthritis of the spine)\]. Efficacy will be measured by reduction in the signs and symptoms of active AS, including effects on back pain and stiffness, physical function, range of motion in the spine, quality of life, and rate of spine damage or fusion on x-ray.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpondylitis, Ankylosing
CountriesBelgium, Canada, Finland, France, Germany, Netherlands, South Korea, Taiwan, United States
CollaboratorsSchering-Plough

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 14, 2005
Enrollment StartDec 1, 2005
Primary CompletionMar 1, 2007
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 20.6 years ago

Interventions

golimumabbiological

100 mg sc injections every 4 wks from wk 0 up to 5 yrs

Golimumab (CNTO 148); placebobiological

SC injections every 4 wks thru wk 20 (unless early escape at wk 16);golimumab - if early escape, 50mg sc inj every 4wks from wk 16 up to 5yrs ;golimumab -50mg sc injection beginning wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100mg

golimumabbiological

50 mg sc injs every 4wks from wk 0 thru 5yrs (unless early escape at wk 16); golimumab - If early escape, 100mg sc injections every 4 wks beginning wk 16 up to 5 yrs ; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100mg