START-Spondylitis Trial of Apremilast for better rheumatic therapy V1

• Research type

  Research Study

• Full title

  Randomized, Double-blind, Placebo-controlled, parallel-group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Ankylosing Spondylitis (AS). START-Spondylitis Trial of Apremilast for better rheumatic therapy

• IRAS ID

  3010

• Sponsor organisation

  Imperial College

• Eudract number

  2008-004229-40

• ISRCTN Number

  not issued

• Research summary

  Ankylosing spondylitis (AS) isa chronic inflammatory disease affecting the spine and occasionally peripherallarge joints. Presently, there are very few treatments available which affectthe progression of the disease in the spine. The only proven treatment is theuse of drugs inhibiting tumour necrosis factor alpha (TNF). However, there arelimitations with this treatment in that it needs to be administered via aninjection and is also very expensive. Therefore it is necessary to develop newtherapeutic agents for this condition.Apremilast (the study drug) is an oral tablet which has been shown toinhibit TNF production in a mouse model of inflammation. It has also been usedin clinical trials for asthma and psoriasis in humans with good affect andtolerability. These studies were funded by Celgene Corporation and they will befunding this study. This study will evaluate the effectiveness of apremilast inAS as measured by improvement in patients?? signs and symptoms of the diseaseand changes in imaging. Additionally the safety and tolerability of apremilastin AS will be assessed. The patients will be recruited from hospitals byConsultant referral. The patients will have had AS for at least 2 years andtheir symptoms will have been uncontrolled on conventional non-steroidalanti-inflammatory drugs such as ibuprofen. Patients will be randomised toeither receive apremilast or a placebo and treated over a period of 12 weeks.They will then be followed up for 28 days after the treatment period.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  08/H0707/137

• Date of REC Opinion

  20 Oct 2008

• REC opinion

  Further Information Favourable Opinion