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METROTEXATE AND PREDNISOLONE STUDY IN ERYTHEMA NODOSUM (MAPS IN ENL) PROTOCOL: A DOUBLE-BLIND RANDOMISED CLINICAL TRIAL
Author
Barros, Barbara de
Lambert, Sabá M.
Shah, Mahesh
Pai, Vivek V.
Darlong, Joydeepa
Rozario, Benjamin Jewel
Alinda, Medhi Denisa
Sales, Anna M.
Doni, Shimelis
Hagge, Deanna A.
Shrestha, Dilip
Listiawan, M. Yulianto
Yitaye, Abeba M.
Nery, Jose A. C.
Neupane, Kapil D.
Dias, Vivianne L. A.
Butlin, Ruth
Nichols, Peter G.
Lockhood, Diana
Walker, Stephen L.
Lambert, Sabá M.
Shah, Mahesh
Pai, Vivek V.
Darlong, Joydeepa
Rozario, Benjamin Jewel
Alinda, Medhi Denisa
Sales, Anna M.
Doni, Shimelis
Hagge, Deanna A.
Shrestha, Dilip
Listiawan, M. Yulianto
Yitaye, Abeba M.
Nery, Jose A. C.
Neupane, Kapil D.
Dias, Vivianne L. A.
Butlin, Ruth
Nichols, Peter G.
Lockhood, Diana
Walker, Stephen L.
Affilliation
London School of Hygiene & Tropical Medicine. Clinical Resaerch Department. London, UK.
London School of Hygiene & Tropical Medicine. Clinical Resaerch Department. London, UK / Clinical Resaerch Department. ALERT Center. Adis Abeba, London, Ethiopia.
The Leprosy Mission Nepal. Department of Dermatology and Mycobacterial Research Laboratories. Kathmandu, Nepal.
Bombay Leprosy Project. Mumbai, India.
The Leprosy Mission Trust India. New Delhi, India.
The Leprosy Mission International Bangladesh. DBLM Hospital. Nilphamari, Bangladesh.
Department of Dermathology and Venereology. Faculty of Medicine Universitas Airlanga, Dr. Soetomo Heneral Hospital, Surabaya, Jawa Timur, Indonesia.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Hanseniase Rio de Janeiro, RJ, Brasil.
Clinical Resaerch Department. ALERT Center. Adis Abeba, London, Ethiopia.
The Leprosy Mission Nepal. Department of Dermatology and Mycobacterial Research Laboratories. Kathmandu, Nepal.
The Leprosy Mission Nepal. Department of Dermatology and Mycobacterial Research Laboratories. Kathmandu, Nepal.
Department of Dermathology and Venereology. Faculty of Medicine Universitas Airlanga, Dr. Soetomo Heneral Hospital, Surabaya, Jawa Timur, Indonesia.
Clinical Resaerch Department. ALERT Center. Adis Abeba, London, Ethiopia.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Hanseniase Rio de Janeiro, RJ, Brasil.
The Leprosy Mission Nepal. Department of Dermatology and Mycobacterial Research Laboratories. Kathmandu, Nepal.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Hanseniase Rio de Janeiro, RJ, Brasil.
The Leprosy Mission International Bangladesh. DBLM Hospital. Nilphamari, Bangladesh.
London School of Hygiene & Tropical Medicine. Clinical Resaerch Department. London, UK.
London School of Hygiene & Tropical Medicine. Clinical Resaerch Department. London, UK.
London School of Hygiene & Tropical Medicine. Clinical Resaerch Department. London, UK.
London School of Hygiene & Tropical Medicine. Clinical Resaerch Department. London, UK / Clinical Resaerch Department. ALERT Center. Adis Abeba, London, Ethiopia.
The Leprosy Mission Nepal. Department of Dermatology and Mycobacterial Research Laboratories. Kathmandu, Nepal.
Bombay Leprosy Project. Mumbai, India.
The Leprosy Mission Trust India. New Delhi, India.
The Leprosy Mission International Bangladesh. DBLM Hospital. Nilphamari, Bangladesh.
Department of Dermathology and Venereology. Faculty of Medicine Universitas Airlanga, Dr. Soetomo Heneral Hospital, Surabaya, Jawa Timur, Indonesia.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Hanseniase Rio de Janeiro, RJ, Brasil.
Clinical Resaerch Department. ALERT Center. Adis Abeba, London, Ethiopia.
The Leprosy Mission Nepal. Department of Dermatology and Mycobacterial Research Laboratories. Kathmandu, Nepal.
The Leprosy Mission Nepal. Department of Dermatology and Mycobacterial Research Laboratories. Kathmandu, Nepal.
Department of Dermathology and Venereology. Faculty of Medicine Universitas Airlanga, Dr. Soetomo Heneral Hospital, Surabaya, Jawa Timur, Indonesia.
Clinical Resaerch Department. ALERT Center. Adis Abeba, London, Ethiopia.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Hanseniase Rio de Janeiro, RJ, Brasil.
The Leprosy Mission Nepal. Department of Dermatology and Mycobacterial Research Laboratories. Kathmandu, Nepal.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Hanseniase Rio de Janeiro, RJ, Brasil.
The Leprosy Mission International Bangladesh. DBLM Hospital. Nilphamari, Bangladesh.
London School of Hygiene & Tropical Medicine. Clinical Resaerch Department. London, UK.
London School of Hygiene & Tropical Medicine. Clinical Resaerch Department. London, UK.
London School of Hygiene & Tropical Medicine. Clinical Resaerch Department. London, UK.
Abstract
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.
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