Efficacy and safety of delayed release prednisolone in GCA

• Research type

  Research Study

• Full title

  A study of efficacy and safety of delayed release prednisolone in newly diagnosed cases of Giant Cell Arteritis

• IRAS ID

  88594

• Contact name

  Bhaskar Dasgupta

• Sponsor organisation

  Southend Hospital

• Eudract number

  2011-005090-22

• ISRCTN Number

  ISRCTN40911426

• Research summary

  What is the effectiveness and safety of delayed release prednisolone in patients with newly diagnosed Giant Cell Arteritis? Giant Cell Arteritis (GCA) is a condition in which there is inflammation of the large arteries, predominantly those in the head and neck. Symptoms can include headache, jaw pain and visual loss. Steroids are the standard treatment. Most patients are required to remain on steroids for 12-36 months. Around 50% of people get a flare-up of their condition and up to 86% get side effects from steroids such as weight gain, fractures, bruising, and diabetes. The main purpose of this study is to decide whether delayed release can maintain control of symptoms in new cases of giant cell arteritis compared to immediate release prednisolone. Other aims will be to investigate how long lasting the response is and whether delayed release prednisolone is safe and well tolerated as compared to the standard immediate release prednisolone. Delayed release prednisolone has been chosen for the study as it has been shown in research studies to be effective at controlling other serious inflammatory diseases such as rheumatoid arthritis. The possible benefit of delayed release prednisolone is better control of giant cell arteritis, requiring less steroid and therefore fewer side effects. The study will be conducted at two University Hospitals in Essex and will last 1 year. Participants need to be aged 50 or over AND newly diagnosed with giant cell arteritis. The study involves 8 clinic visits for participants during the 6 months they are enrolled. Each visit will require blood tests, physical examination and completing questionnaires. Initial treatment will be with standard prednisolone for 4 weeks after diagnosis following which participants will be randomly assigned to 1 of 2 groups ?? to get either delayed release prednisolone or standard prednisolone for the duration of the study.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  11/LO/1821

• Date of REC Opinion

  25 Jan 2012

• REC opinion

  Further Information Favourable Opinion