GO-AHEAD

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Effect of Golimumab Administered Subcutaneously in Subjects with Active Axial Spondyloarthritis

• IRAS ID

  89139

• Contact name

  Andrew Ostor

• Sponsor organisation

  Schering-Plough Research Institute, a Division of Schering Corporation

• Eudract number

  2011-000311-34

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  Axial spondyloarthritis (axial SpA) is a chronic inflammatory disease of the axial skeleton, the symptoms of which are back pain and progressive stiffness of the spine. Axial spondyloarthritis (axial SpA) is thought to be an earlier manifestation of ankylosing spondylitis.Currently, there are only two main drug treatments for ankylosing spondylitis (AS) which are widely accepted: non-steroidal anti-inflammatory drugs (NSAIDs) and tumour necrosis factor (TNF)-a antagonists, including Golimumab. TNF antagonists are highly anti-inflammatory and would therefore be expected to be an effective treatment in patients with active inflammation of axial SpA. This is a Phase 3b, two part, randomised, parallel group, multi-site, double blind, placebo controlled trial with an open label extension evaluating Golimumab (GLM) 50mg given subcutaneously, versus placebo in adults aged 18 to 45 years old with active axial spondyloarthritis. During part 1, patients will be randomised on a 1:1 ratio to receive either GLM or placebo. Part 2 will be the open-label extension with all patients receiving GLM, during which long term safety and efficacy will be evaluated. There will be approximately 200 patients randomised in the study worldwide.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  11/EE/0450

• Date of REC Opinion

  19 Jan 2012

• REC opinion

  Further Information Favourable Opinion