Methotrexate and Prednisolone study (MaPs) is the largest clinical trial on in Erythema Nodosum Leprosum (ENL) treatment ever to be conducted. We aim to recruit 414 participants across six centres.
MaPs is a study conceived, developed, and implemented by the ENLIST group. Our dedicated ENLIST team is composed by experienced clinicians, laboratory scientists and health researchers from around the world.
Other activities will run alongside the trial, including clinical trial training evaluation, economic assessment, and quality of life assessments. We want to establish a solid framework to facilitate future clinical trials clinical trials in leprosy and leprosy reactions.
MaPs will take place in six leprosy referral centres in five countries: Bangladesh, Ethiopia, India, Indonesia, and Nepal.
Study completion
The study has now been completed.
Recruitment was finalised on 25 August 2025, marking the successful conclusion of this large multicentre randomised controlled trial.
Recruitment
- A total of 231 individuals were screened, and
- 137 participants were recruited across participating centres
MaPs is sponsored by the London School of Hygiene & Tropical Medicine, UK.
Collaborating partners: AHRI Alert, The Leprosy Mission, Leprosy Mission Nepal, Bombay Leprosy Project, Dr Soetomo, Leonard Wood
Funders: Leprosy Research Initiative, Turing Foundation
- AHRI/ALERT Hospital
-
Dr. Saba Lambert: Registered doctor with a licence to practice in Ethiopia. She has have worked in Ethiopia for 8 years, 6 of which were based at ALERT Hospital under a research project sponsored by the London School of Hygiene and Tropical Medicine, for which she obtained her PhD in 2015. During her time at ALERT, she worked with AHRI on various projects, was involved in teaching in the ALERT training centre on leprosy courses, was a founding member of the LEAG (Leprosy Expert Advisory Group) and was involved in many leprosy projects with the Ministry of Health (Leprosy Mapping and Leprosy Referral Centres Assessment and Strengthening). She has presented the ALERT work at many international conferences. She has a passion for her work in Leprosy and especially for ALERT.
Dr. Shimelis Doni: Currently I am working as a clinician and head of Dermatology Department at ALERT Hospital.
Primary Affiliation: All African Leprosy and Dermatology Education and Training Center - Addis Ababa, Ethiopia
Specialties: Dermatovenereology
Research Interests: Leprosy, dermatology and seal transmitted infection
- DBLM Hospital Program, The Leprosy Mission International – Bangladesh
-
Dr. Benjamin Jewel Rozario: Residential Medical Officer, DBLM Hospital Program, The Leprosy Mission International -Bangladesh.
Responsible for medical care and medical services of DBLM Hospital including surgery, and with the team of staff work towards holistic care of people affected by leprosy or other disabilities. Responsible for supervising all medical, surgical and disability services, providing necessary supervision for physiotherapy technicians and assistive device section, laboratory and nursing department and responsible for usage of budget. Also responsible for facilitating good understanding and smooth cooperation between all different persons involved in the project and other relevant stakeholders, including local officials in health and civil administration, and other NGOs who refer patients to DBLM Hospital.
- The Leprosy Mission Trust India
-
Dr. Joydeepa Darlong: Experienced leprologist with a demonstrated history of working in the non-profit organization management industry. Skilled in Non-profit Organizations, Epidemiology, Research, Fundraising, Monitoring evaluation, quality assurance and infectious diseases and International Health.
- The Leprosy Mission Nepal – Anandaban Hospital, Nepal
-
Dr. Deanna Hagge, PhD: Research Scientist, Nepal. She is the Research Director of the Mycobacterial Research Laboratories (MRL) at Anandaban, a tertiary leprosy referral hospital in Kathmandu, Nepal where she has worked since 2007. Previously, she spent a decade in leprosy laboratory research with the Molecular Biology and Immunology Departments of the U.S. Department of Health and Human Services National Hansen’s Disease Programs. She acts as the onsite coordinator for several international collaborative research projects as well as primary clinical and laboratory studies. Leprosy research areas include: clinical trials, immunological complications, drug resistance, medical chart reviews, patient surveys, diagnostics, neuropathy, genetic susceptibility, transmission and helminth co-infections.
- Dr. Soetomo General Hospital – Surabaya, Indonesia
-
Dr. Medhi Denisa Alinda: Dermatologist from Surabaya, Indonesia, who works in the Leprosy Division. She graduated from the Universitas Airlangga Medical Faculty in 2014, she was the youngest graduate. Dr. Medhi has been practising in the Department of Venereology Dr. Soetomo Hospital, one of the referral hospital in East Java. Her practice focuses on Leprosy at the Dr. Soetomo Hospital and the Tropical Disease Centre. She also often fills a charity event for leprosy patients and for general practitioners. Currently she has already been part in many research projects about leprosy.
- Bombay Leprosy Project – Mumbai, India
-
Dr. Vivek V. Pai: Director - Bombay Leprosy Project
- Medical Officer in Bombay Leprosy Project for 1987 to 1993.
- Assistant Director in Bombay Leprosy Project since 1993 to March 1996.
- Dy Director in Bombay Leprosy Project April 1996 to 2004.
- Addl. Director in Bombay Leprosy Project since January 2004 and currently Director since February 2007 till date.
A number of visits are scheduled during the study. Each centre will be visited twice a year at least. These visits will be an excellent opportunity for the study team to address any clinical and administrative issues that might happen and to update documents and procedures if necessary.
- Visit to TLM Nepal - Anandaban Hospital, Nepal
The first study site visit happened in the preparation phase.
Nepal – Anandaban Hospital November 2018 Anandaban Hospital is a special place, specialised in tertiary leprosy care. We are looking forward to our next visit.
Anandaban hospital beautiful garden Photo below is the entrance of Anandaban hospital administrative area, in the top photo at the left is Princess Diana in 1993 visiting the hospital, talking to patients. Years later, her son, Prince Harry, also visited Nepal and received a copy of his mother’s photo.
- Visit to Bombay Leprosy Project - Mumbai, India
And we kick off our project in November 2022!
Dr. Barbara de Barros travelled to India on the 31st October for 6 weeks to expedite the start training and recruitment.
Bombay Leprosy Project (BLP) is an NGO founded by Dr R Ganapati, an eminent Leprologist, who has transformed leprosy work from a closed institutionalised endeavour to a widespread community based work. Based in the city of Bombay (Mumbai) since 1976, BLP is managed by a team of dedicated staff leaded by Dr. Vivek Pai and is recognised as an outstanding scientific organisation by the Government of India, local state government and international scientific bodies like WHO.
It is a pleasure to work with such a enthusiastic team!
Bellow is the BLP team.
Dr. Bhagyashree enrolling first participant on our study MaPs!
- Visit to TLM Barabanki hospital - Barabanki, India
TLM Barabanki Hospital was established in the year 1961.The Mission to Lepers (now, The Leprosy Mission Trust India) started work amongst people affected by leprosy in Barabanki, in 1958, as a weekly roadside clinic run by its Faizabad hospital. Dr Frances Bramwell, Dr Chandy and Dr G.S. Partick, working in TLM Faizabad Hospital pioneered these clinics. In 1961, it became a full-fledged hospital, and in 1978, it became a separate, independent hospital.
- Visit to TLM Nepal - Anandaban Hospital, Nepal
On my second visit to Anandaban Hospital, I was welcomed by the hospital amazing team. The gardens are still beautiful and we had curious little neighbours in t he lab. I found a few differences from the last time. A new hospital wing is now ready to start receiving patients. The laboratory building had to adapt to COVID-19 rules and it got a new outside staircase.
New building constructed since 2018 at Anandaban Hospital. 
Mycobacterial Research Laboratories with new staircase outside the main entrance. We started with the right foot, with Dr. Bishwanath Acharya, clinical researcher, we set up MaPs, training the team and screened participants.
Despite raining season, the weather in Anandaban Hospital was very pleasant. And as always walking around the hospital garden is a pleasure. But not in the evening, tiggers are around, unlike our friends the monkeys, we need to stay away from them.
MaPs research team at Anandaban Hospital. 
Gardens at the Anandaban guesthouse with views to the valley - Visit to ALERT Hospital, Addis Ababa - Ethiopia
The study manager, Dr. Barbara de Barros, visited Ethiopia between March and June 2024 to train staff and initiate recruitment at ALERT Hospital in Addis Ababa.
ALERT MaPs team – the dedicated clinicians leading the study in Addis. From left to right: Dr. Barbara de Barros, Dr. Abdulnaser Hamza, Dr. Alemtsehay Getachew and Dr. Shimelis Doni ALERT (All Africa Leprosy, Tuberculosis and Rehabilitation Training) Hospital was founded in 1934 and is today recognised as a centre of excellence for leprosy, dermatology, and rehabilitation in Africa.
Entrance to the Research Institute at ALERT Hospital It combines high-quality patient care with cutting-edge research and training. The hospital has a long history of international collaborations and remains at the forefront of leprosy research and treatment.
Working alongside the dedicated team at ALERT has been an inspiring experience, and we are delighted to have launched recruitment with such committed partners.
Of course, not everything was work – in her free time, MaPs study manager Dr. de Barros explored Addis Ababa, including a visit to the National Museum to meet Dinknesh (“Lucy”), the world-famous early hominid fossil.
Garden in Addis Ababa 
At the National Museum, Addis Ababa – Dr. Barbara de Barros and Dinknesh (“Lucy”)
Read the study protocol.
Training slides
- Session 1 – MaPs study, introduction, design and structure
- Session 2 – MaPs training Log and Standard Operation Procedure
- Session 3 – Methotrexate
- Session 4 – REDCap
- Session 5 – MaPs recruitment process
- Session 6 – Consent
- Session 7 – Laboratory tests and chest x-ray
- Session 8 – Allocation concealment randomisation
- Session 9 – ENLIST ENL Severity Scale
- Session 10 – Participant reported outcome measurement and Quality of Life Questionnaires
- Session 11 – First Assessment
- Session 12 – Follow up assessment
- Session 13 – Adverse Events
- Session 14 – Additional prednisolone
- Session 15 – Study completion or termination
Videos
- Session 1 – MaPs study, introduction, design and structure
- Session 2 – MaPs training Log and Standard Operation Procedure
- Session 3 – Methotrexate
- Session 4 – REDCap
- Session 5 – MaPs recruitment process
- Session 6 – Consent
- Session 7 – Laboratory tests and chest x-ray
- Session 8 – Allocation concealment randomisation
- Session 9 – ENLIST ENL Severity Scale
- Session 10 – Participant reported outcome measurement and Quality of Life Questionnaires
- Session 11 – First Assessment
- Session 12 – Follow up assessment
- Session 13 – Adverse Events
- Session 14 – Additional prednisolone
- Session 15 – Study completion or termination
- Barbara de Barros
-
I am an infectious disease doctor from Brazil. I moved to London to do a MSc in Control of Infectious. Following my degree, I applied for a position at LSHTM as a clinical research fellow with the Leprosy team. In 2018 I started working on MaPs. It was and still is an exciting experience. MaPs is my PhD project too.
During the covid-19 pandemic, when the study was on hold, I worked intensely to keep the trial on track. At that time, I worked from home.
We are about to start recruiting so I need to have everything in order. My typical day starts answering e-emails from partners and collaborators. Normally I have a zoom meeting with one of our partners or our project manager Luciana Alves, also a Brazilian. She has been a key colleague liaising with partners and other administrative officers at LSHTM.
My home office is not that bad when the weather in London is sunny.
But I miss the office. We have a nice building in central London, just around the corner of the British Museum, where sometimes I like to take a lunch break.
Sometimes, as part of the job, I teach the MSc students. My favourite class to teach is the leprosy practical lessons, where I demonstrate how to examine to do skin biopsies and skin slit smears.
Part of the job is to review articles and be up to date with leprosy research. Normally I like to have a quiet reading time in the library.
One day a week I attend the leprosy clinic at the Hospital for Tropical Diseases with Dr. Steve Walker, MaPs principal investigator.
Soon I will start to travel to the study sites.
Next time you will follow me to our first travel!
The Methotrexate and Prednisolone study in Erythema Nodosum Leprosum (MaPs) was strongly represented at the 22nd International Leprosy Congress in Bali, July 2025. The meeting served as both a scientific forum and an opportunity for a dedicated MaPs pre-conference gathering, held jointly with the ENLIST network. All collaborating centres and study researchers participated, making it an important milestone for the trial.
The LSHTM team — Prof. Diana Lockwood, Prof. Steve Walker, Dr. Saba Lambert, and Dr. Barbara de Barros — joined colleagues from India, Nepal, Ethiopia, and Indonesia to review MaPs progress and share research findings. The study was showcased through multiple oral presentations, including four from Dr. de Barros’ PhD research.
Prof. Lockwood, Prof. Walker, and Dr. Lambert also led key sessions in the main congress programme, with Prof. Lockwood delivering a lecture in the closing plenary. The visibility of MaPs at the congress reflects the collaborative achievements of all participating centres and their contribution to advancing evidence-based treatment for ENL.
The 20th International Leprosy Congress - Manila, The Philippines
MaPs protocol was presented at the ILC in 2019.
More than 1,000 delegates from 55 countries met in Manila to share research and experience on all facets of leprosy.
Our group and our partners presented in several sessions.
The International Leprosy Congress is a once-in-three-years ‘snapshot’ of the leprosy world.
ENLIST meeting - 8 November 2022, Hyderabad, India
21st International Leprosy Congress - 9-11 November 2022, Hyderabad, India
LRI Spring Meeting - 20th and 21st April 2023
