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A randomised, controlled trial to compare prednisolone with doxycycline Most common autoimmune blistering disease in Western Europe Incidence: estimates vary - audit of the Oxfordshire region (2001-4) showed incidence of 33.4 cases/million/year Oral prednisolone most common treatment in UK (UK DCTN survey) and Germany (30 hospitals) ◦ This is an effective drug but has many side effects, especially severe in this elderly population Rationale for the study: ◦ Clinical equipoise between steroids and tetracyclines for the treatment of bullous pemphigoid. ◦ Question identified by Cochrane systematic review and UK DCTN Research question: ◦ Is doxycycline sufficiently effective and safe to be used as a first line treatment for bullous pemphigoid? Primary objectives: ◦ Safety: Measured by the number of significant blisters present at week 6 ◦ Effectiveness: Measured by the number of severe side effects present at one year Multi-centre randomised controlled trial with a pragmatic design 3 year recruitment period with a 1 year follow up for each patient – visits at baseline and weeks 3, 6, 13, 26, 39 and 52 256 patients will be recruited, approx 156 from the UK (40 sites) and 100 from Germany (7 sites) 7 patients recruited at each site Investigator is single – blind for the first 6 weeks but after this is free to amend the dose of the trial medication Prednisolone 0.5mg/kg/day (to be given as a single dose each morning) or Doxycycline 200mg (once a day) Mometasone furoate (Elocon) cream or ointment (0.1%) permitted as rescue medication. Applied to blisters / lesions for first 3 weeks and weeks 6 - 52of study Aged 18+ and able to give informed consent Clinical diagnosis of bullous pemphigoid At least 3 significant blisters or erosions over 2 or more body sites No previous episodes of bullous pemphigoid or treatment for BP for previous year (topical steroids allowed) Mainly or entirely mucosal pemphigoid The research question developed from a thorough literature search supported by clinical impression of experts in the field Trial developed by the UK DCTN - rigorous process Funded by the National Institute for Health Research highly competitive International collaboration will ensure sufficient recruitment and support from leaders in the field Refer to a dermatologist who is involved with BLISTER OR Contact Caroline, the trial manager on ◦ 0115 884 4925/ 07989 206252 Please don’t prescribe any oral therapy before the patient has been assessed for the trial. You can prescribe Elecon cream or ointment if required. Website: www.blistertrial.co.uk