Low Dose Interferon Alpha Treatment for Oral Ulcers of Behcet's Disease
Behcet SyndromeBehcet Disease1 moreThe purpose of this study is to determine the safety and efficacy of natural human interferon alpha (IFN alpha) on size, number, incidence and pain of oral ulcers associated with Behçet's Disease (BD).
1 Year of Treatment With Canakinumab in Behçet's Disease Patients With Neurologic or Vascular Involvement...
Behcet DiseasePrimary objective of the study was to evaluate the safety and efficacy of canakinumab on the clinical and inflammatory findings of Behced Disease patients with neurologic and vascular involvement.
A Study to Evaluate Efficacy and Safety of Infliximab in Participant With Moderate-to-Severe Refractory...
Behcet DiseaseThe purpose of this study is to evaluate the efficacy of infliximab in induction regimen by assessing the mean decrease in Disease Activity Index for intestinal Behcet's disease (DAIBD) score of 20 or more in participants with active intestinal Behcet's disease who are refractory to conventional therapies.
Saline vs. Lactated Ringers for Emergency Department IV Fluid Resuscitation
Fluid LossSymptom Complex2 moreAdministration of intravascular (IV) fluid is the most common emergency department (ED) procedure. IV fluids are integral to increasing effective blood volume and ensuring organ perfusion in patients with volume depletion and dehydration. There are many options of IV fluids providers can use when treating ED patients. Surveys show physicians do not cite an evidence-based reason for selecting the crystalloid IV fluid used; the decision was likely to be influenced by type and location of practice. A gap exists in the current literature, as there is no evidence for the optimal IV fluid choice for the ED patient requiring IV fluid before discharge. Normal saline (NS) is commonly used as an IV fluid replacement in ED patients. However, NS has been associated with increased risk of acidosis and acute kidney injury. This study will use a novel approach of a patient-centered outcome in a non-critically ill population to ascertain the optimal IV fluid for patient quality of recovery. The results of this study will inform provider's IV fluid decisions between NS and LR. More importantly, the results of this study will have the power to improve patient's quality of recovery following IV fluid administration and subsequent ED discharge. ED patients will be recruited, and participants will be randomized to receive one of two IV solutions (Lactated ringer's or normal saline). Participants will answer a survey before and after the intervention to assess their quality of recovery. The post-survey will be administered by phone after ED discharge. Participants will also be contacted by text message one week following their ED visit to gather information on their healthcare utilization.
Efficacy and Safety of Ustekinumab, a Human Monoclonal Anti-IL-12/IL-23 Antibody, in Patients With...
Behçet DiseaseThe purpose of this study is to evaluate the proof of concept of efficacy of ustekinumab in subjects with Behçet disease, including patients with oral ulcers (STELABEC-1) and patients with active posterior uveitis or panuveitis (STELABEC-2)
Phase III Study in Refractory Behcet's Disease
Behcet DiseaseThe purpose of this pivotal trial is to evaluate subcutaneous (SQ) AIN457 as an adjunctive therapy to reduce the rate of exacerbations of posterior uveitis or panuveitis secondary to Behçet's disease during the 24 weeks of study therapy as compared to standard of care alone.
The Role of Rosuvastatin on Vascular Involvement in Behçet's Disease
Behcet's DiseaseBehçet's Disease(BD) is a systemic inflammatory vasculitis, which affects all types and sizes of vessels. Statins display numerous effects often independent of the well-established lipid-lowering effects that may be of benefit in retarding or preventing vascular injury and ischaemic vascular events. The aim of the present study was to determine the efficacy of rosuvastatin in improving vascular dysfunction and vascular inflammation and to assess the effect of rosuvastatin on vascular involvement in BD patients. Fifty-six BD patients (51 males and 5 females) mean age 33.4 years, mean disease duration 5.8 years), all fulfilling the classification criteria of the International Study Group for Behçet's disease were recruited.Patients were randomised into 2 groups. The first group (n=27: 20 active and 7 inactive) were assigned to receive 40 mg of rosuvastatin and the second group(n=29: 21 active and 8 inactive) received placebo for 12 months. Inflammatory and endothelial dysregulation markers were measured at baseline and after 12 months. All patients were examined for vascular involvement. Venous or arterial system involvement was defined as present when confirmed by Doppler ultrasonography, magnetic resonance angiography, conventional angiography or CT.
Topical Pentoxifylline Gel on Behcet's Disease Oral Ulcers
Behçet Disease Affecting Oral MucosaAlthough Behçet's Disease (BD) has no FDA-approved therapies, numerous clinical reports suggest that oral ulcers of BD may resolve when treated with systemic ingested pentoxifylline (PTX). The investigators here propose to investigate the therapeutic potential of PTX dissolved in muco-adherent formulation and directly applied to the oral lesions. This 60 patient proof of concept trial is designed to meet regulatory requirements for safety concerns while at the same time exploring the potential efficacy and clinical utility of this product. The investigators hypothesize that application of topical PTX will accelerate the healing of these lesions in a clinically meaningful way, and further hypothesize that topical PTX can become a valuable adjunct to any other systemic therapy for BD.
Induction Therapy With Anti-TNFα vs Cyclophosphamide in Severe Behçet Disease
Behcet's DiseaseVasculitisBehçet's disease (BD) is a systemic vasculitis of arterial and venous vessels of any size, involving young patients (from 15 to 45 years). BD significantly increases morbidity and mortality. Therapeutic management of BD depends on the clinical presentation and organ involved. Although colchicine, nonsteroidal antiinflammatory agents and topical treatments are often sufficient for mucocutaneous and joint involvement, more aggressive approach with immunosuppressive agents is warranted for severe manifestations. Early recognition and vigorous use of immunosuppressives with high dose steroids have changed the prognosis of patients with severe BD. BD is a severe systemic vasculitis leading to blindness in up to 20% at 4 years and a 5-year mortality rate of 15% in patients with major vessel or neurological involvement. Cyclophosphamide has been used for life-threatening BD for 40 years. However, the outcome of severe complications of BD is poor. The European League Against Rheumatism (EULAR) recommendation for the management of BD advocated cyclophosphamide plus glucocorticoids for life-threatening manifestations (i.e neurological and/or major vessel involvement). TNFa antagonists have been used with success in severe and/or resistant cases. In addition, the incidence of blindness in BD has been dramatically reduced in the recent years with the use of anti-TNF. However, there is no firm evidence or randomized controlled trials directly addressing the best induction immunosuppressive therapy in severe BD manifestations. The investigators therefore aimed to assess the best induction therapy in severe and difficult to treat BD patients. The investigators hypothesize that up to 70% of the patients with life-threatening manifestations of BD receiving these compounds [anti-TNFa or cyclophosphamide] will achieve a complete remission of BD at 6 months and with less than 0.1 mg/kg/day of prednisone. ITAC, is the first randomized prospective, head to head study, comparing infliximab, to cyclophosphamide in severe manifestations of BD. There is no firm evidence or randomized controlled trials directly addressing the best induction immunosuppressive therapy in severe BD. Cyclophosphamide failed to demonstrate sustainable remission over 70 % of life threatening BD cases. There is little published information on use of immunosuppressants other than cyclophosphamide for severe BD. TNFa antagonists have been used with success in severe and/or resistant cases. TNFa expression correlates with BD activity and other immunological data provide a strong rationale for targeting BD with biologics. Despite a strong rationale, these compounds are not yet approved in BD, which guarantees the innovative nature of this study that aims selecting or dropping any arm when evidence of efficacy already exists.
Rituximab for the Treatment of Severe Ocular Manifestations of Behcet's Disease
Behcet's SyndromeThe purpose of this study is to find if Rituximab can improve severe ocular lesions of Behcet's Disease.