RT Journal Article
SR Electronic
T1 Methotrexate and prednisolone study in erythema nodosum leprosum (MaPs in ENL) protocol: a double-blind randomised clinical trial
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e037700
DO 10.1136/bmjopen-2020-037700
VO 10
IS 11
A1 Barbara de Barros
A1 Saba M Lambert
A1 Mahesh Shah
A1 Vivek V Pai
A1 Joydeepa Darlong
A1 Benjamin Jewel Rozario
A1 Medhi Denisa Alinda
A1 Anna M Sales
A1 Shimelis Doni
A1 Deanna A Hagge
A1 Dilip Shrestha
A1 M. Yulianto Listiawan
A1 Abeba M Yitaye
A1 Jose A C Nery
A1 Kapil D Neupane
A1 Vivianne L A Dias
A1 C. Ruth Butlin
A1 Peter G Nicholls
A1 Diana Lockwood
A1 Stephen L Walker
YR 2020
UL http://bmjopen.bmj.com/content/10/11/e037700.abstract
AB Introduction Erythema nodosum leprosum (ENL) is an immunological complication of leprosy. ENL results in morbidity and disability and if it is not treated can lead to death. The current treatment consists of thalidomide or high doses of oral corticosteroids for prolonged periods. Thalidomide is not available in many leprosy endemic countries. The use of corticosteroids is associated with morbidity and mortality. Identifying treatment regimens that reduce the use of corticosteroids in ENL is essential. Methotrexate (MTX) is used to treat many inflammatory diseases and has been used successfully to treat patients with ENL not controlled by other drugs, including prednisolone and thalidomide. We present the protocol of the ‘MTX and prednisolone study in ENL’ (MaPs in ENL) a randomised controlled trial (RCT) designed to test the efficacy of MTX in the management of ENL.Methods and analysis MaPs in ENL is an international multicentre RCT, which will be conducted in leprosy referral centres in Bangladesh, Brazil, Ethiopia, India, Indonesia and Nepal. Patients diagnosed with ENL who consent to participate will be randomly allocated to receive 48 weeks of weekly oral MTX plus 20 weeks of prednisolone or 48 weeks of placebo plus 20 weeks of prednisolone. Participants will be stratified by type of ENL into those with acute ENL and those with chronic and recurrent ENL. The primary objective is to determine whether MTX reduces the requirement for additional prednisolone. Patients’ reported outcome measures will be used to assess the efficacy of MTX. Participants will be closely monitored for adverse events.Ethics and dissemination Results will be submitted for publication in peer-reviewed journals. Ethical approval was obtained from the Observational/Interventions Research Ethics Committee of the London School of Hygiene & Tropical Medicine (15762); The Leprosy Mission International Bangladesh Institutional Research Board (in process); AHRI-ALERT Ethical Review Committee, Ethiopia; Ethics Committee of the Managing Committee of the Bombay Leprosy Project; and The Leprosy Mission Trust India Ethics Committee; the Nepal Health and Research Council and Health Research Ethics Committee Dr. Soetomo, Indonesia. This study is registered at www.clinicaltrials.gov. This is the first RCT of MTX for ENL and will contribute to the evidence for the management of ENL.Trial registration numberNCT 03775460.