BIO BEHÇET’S
Research type
Research Study
Full title
Optimal utilisation of biologic drugs in Behçet’s Disease: a randomised controlled trial of infliximab (IFX) verses alpha interferon (aIFN), with genotyping and metabolomic profiling, towards a stratified medicines approach to treatment.
IRAS ID
155076
Contact name
Robert J Moots
Contact email
Eudract number
2014-005390-36
Duration of Study in the UK
3 years, 11 months, 30 days
Research summary
Behçet’s Disease (BD) is a rare and poorly understood auto inflammatory condition causing blindness, stroke and death. Furthermore, the adverse effects from long term treatment with steroids and immunosuppressants lead to additional morbidity and mortality. Recently, the biologic drugs infliximab and interferon alpha (aIFN) have been used successfully in treating BD however they are expensive (£16,000/year and £4,000/year, respectively) and treatment response is variable. Most research informing biologic drug usage in BD is limited as it is carried out in countries where BD is more prevalent including no randomisation or blinding in the study design. Moreover, there are no randomised controlled studies directly comparing infliximab and aIFN therefore drug choice is currently based on physician preference, with a weak evidence base and no biomarkers to help direct therapy. UK Clinical experience suggests treatment response to biologics in BD differs from that reported in other countries however no formal evaluation has been carried out. This is detrimental not only from a patient and clinician perspective but also in terms of NHS resource wastage.
The Department of Health has recently commissioned three National Centres of Excellence for BD in London, Birmingham and Liverpool, with the remit to deliver care for the approximate 500 UK patients currently with this condition. This study brings together expertise from these centres together with academic experts in clinical trial design / management in a new collaboration uniquely equipt to address these problems. This is the first pragmatically designed prospective, randomised clinical trial that will compare infliximab with aIFN in patients with BD, following the clinical pathway established by the national centres of excellence. We will also evaluate a potential biomarker for response to aIFN in BD. Research suggests that the IL-28b polymorphism is predictive of treatment response in patients with hepatitis C and B: consequently, patients will be genotyped for this polymorphism to explore whether it is also effective in predicting the response to aIFN in BD.
The results from this study will inform clinical decision making in the future by improving understanding of treatment options - enhancing patient care and outcomes together with delivering better value for money to the NHS.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0008
Date of REC Opinion
17 Feb 2015
REC opinion
Further Information Favourable Opinion