TARGET-DLE version 1.0
Research type
Research Study
Full title
A single arm, phase II open label trial to investigate the efficacy and safety of intra-dermal injection of etanercept for remission induction in discoid lupus erythematosus
IRAS ID
179520
Contact name
Paul Emery
Contact email
Sponsor organisation
Unviersity of Leeds
Eudract number
2015-001602-33
Duration of Study in the UK
1 years, 10 months, 1 days
Research summary
Discoid lupus is a chronic skin rash which for unknown reasons, causes the immune system to attack the body’s own skin, leading to inflammation. Uncontrolled inflammation in discoid lupus which usually occurs on visible area of the body, can lead to permanent scarring. This will pose a huge impact on patient’s self-esteem and quality of life. There is no guideline on how to treat this condition. Current treatment with an immunosuppressant; anti-malarial drug is only effective in about 50% of the patients. There is also variability in assessing disease activity in the skin as this relies heavily on clinician’s subjective assessment. We are conducting this study to test a new drug called etanercept to treat discoid lupus. Etanercept has been approved in other immune conditions like rheumatoid arthritis, psoriasis and psoriatic arthritis. All patients who wish to participate must have active discoid lupus despite treatment with an anti-malarial drug. This study will take place in a single centre in Leeds and will run for 4 months. Etanercept will be given through direct injection to the surface of the rash (intra-dermal) by the doctor. The single and most active rash will be treated throughout the study. The injection will be given once a week for 12 weeks. If the rash clears before week 12, the treatment will be stopped. We also would like to develop new tests to measure skin inflammation by scanning the skin using optical coherence tomography (OCT), thermography and laser doppler imaging (LDI) and taking photographs of the rash (to be done before and after treatment). If the findings from these new tests are similar to the ones from taking a sample of skin (biopsy), then the latter (which is an invasive test) can be avoided. This study is funded by the National Institute for Health Research (NIHR).
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
15/YH/0257
Date of REC Opinion
20 Jul 2015
REC opinion
Further Information Favourable Opinion