Apremilast(CC-10004) in the Treatment of Active Ankylosing Spondylitis

• Research type

  Research Study

• Full title

  A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF ACTIVE ANKYLOSING SPONDYLITIS

• IRAS ID

  105129

• Contact name

  Peter Taylor

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2011-001555-37

• Clinicaltrials.gov Identifier

  NCT01583374

• Research summary

  Ankylosing Spondylitis (AS) is a long term condition associated with pain and progressive stiffness in the lower back. It can also involve the entire spinal column and some joints away from the spine. In the early stages, the area of the lower back and hip bone become inflamed and painful. Inflammation also occurs in tendons (which join muscle to bones) and in ligaments (which join bones together). Over time, this inflammation may cause new bone to grow, in particular between the bones of the back, eventually fusing them together which causes stiffness and immobility in the spinal column. The purpose of this study is to test two doses of the study drug apremilast and compare its effects to placebo (dummy drug). This study will test how well the body may tolerate apremilast taken by mouth and how well apremilast may treat ankylosing spondylitis. Approximately 456 AS patients will participate in this research study with about 25 patients participating in the UK. The total time the participating patient could be in the study is about 5 years 2.5 months (which is 270 weeks). The study involves: ?½ Screening Phase Up to 6 weeks ?½ Placebo-controlled Treatment Phase Up to 24 weeks ?½ Extension Treatment Phase Up to 236 weeks ?½ Observational Follow-up Phase Up to 4 weeks For the first 24 weeks the participant will receive one of the following:- ?½ Apremilast 20 mg twice daily; or ?½ Apremilast 30 mg twice daily; or ?½ Placebo twice daily. Participating patients will have a chance of early escape at Week 16 or second escape at week 24 depending on improvement of their condition. This means that the patient will be moved to receive apremilast 30 mg twice daily. The study involves procedures including: Physical examinations; eye examinations; stool test; pregnancy tests (if applicable); ECG, x-rays; blood and urine tests; questionnaires; taking study drug; and optional MRI.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  12/WM/0215

• Date of REC Opinion

  4 Sep 2012

• REC opinion

  Further Information Favourable Opinion