Dataset for the Methotrexate and Prednisolone Study (MaPs) in Erythema Nodosum Leprosum: a multicentre randomised controlled trial
de Barros, B
(2026).
Dataset for the Methotrexate and Prednisolone Study (MaPs) in Erythema Nodosum Leprosum: a multicentre randomised controlled trial.
[Dataset].
London School of Hygiene & Tropical Medicine, London, United Kingdom.
10.17037/DATA.00005297.
(2026).
Dataset for the Methotrexate and Prednisolone Study (MaPs) in Erythema Nodosum Leprosum: a multicentre randomised controlled trial.
[Dataset].
London School of Hygiene & Tropical Medicine, London, United Kingdom.
10.17037/DATA.00005297.
This dataset contains individual-level participant data collected as part of the Methotrexate and Prednisolone Study (MaPs) in Erythema Nodosum Leprosum (ENL), a multicentre, double-blind, placebo-controlled randomised clinical trial conducted in Ethiopia, India, Indonesia and Nepal. The trial evaluated the efficacy and safety of weekly oral methotrexate in combination with prednisolone compared with prednisolone alone for the treatment of ENL. The dataset includes demographic characteristics, clinical assessments, ENLIST ENL Severity Scale (EESS) scores, treatment allocation (de-identified), medication use, adverse events, laboratory results and health-related quality of life measures (Dermatology Life Quality Index [DLQI] and SF-36) collected during 60 weeks of follow-up.
Additional Information
**Data access is embargoed until 1 July 2028 to enable further analysis and publication.** To balance participant confidentiality with research reproducibility and data sharing conditions, access to data is managed through a safeguarded application process. Researchers are asked to complete an application form, specifying the variables they wish to access. This list will be reviewed to assess re-identification risks and determine any necessary anonymisation measures, such as grouping ages, broadening dates, or redacting text. Where full anonymisation is not possible, researchers will be required to sign a Data Transfer Agreement (DTA) that sets out data security requirements before access is granted.
Keywords
Erythema Nodosum Leprosum; Leprosy reaction; Methotrexate| Item Type | Dataset |
|---|---|
| Resource Type |
Resource Type Resource Description Dataset Quantitative |
| Description of data capture | Data were collected prospectively during the trial. Participants underwent standardised clinical assessments at scheduled study visits over 60 weeks. Data collection included clinician-completed case report forms, validated health-related quality of life questionnaires (DLQI and SF-36), ENLIST ENL Severity Scale (EESS) assessments, laboratory investigations, medication records and adverse event reporting. Data were entered into a secure REDCap electronic database using standard operating procedures and quality assurance procedures. The study documentation and database were maintained in English. Participant-reported outcome measures and clinical assessments were administered using validated translations in the relevant local languages. |
| Capture method | Other |
| Collection Period |
From To 12 January 2023 28 August 2025 |
| Date | 30 June 2026 |
| Language(s) of written materials | English |
| Creator(s) |
de Barros, B
|
| LSHTM Faculty/Department | Faculty of Infectious and Tropical Diseases > Dept of Clinical Research |
| Research Group | ENLIST group |
| Participating Institutions | London School of Hygiene & Tropical Medicine, London, United Kingdom; The Leprosy Mission Trust India, Barabanki Hospital; Bombay Leprosy Project; The Leprosy Mission Nepal, Anandaban Hospital; Dr. Soetomo General Academic Hospital, Surabaya, Indonesia; ALERT Comprehensive Specialized Hospital, Addis Ababa, Ethiopia |
| Funders |
Project Funder Grant Number Funder URI Methotrexate and Prednisolone Study (MaPs) in ENL ITCRZM2510 UNSPECIFIED Methotrexate and Prednisolone Study (MaPs) in ENL 704.16.71 https://doi.org/10.13039/501100021734 |
| Date Deposited | 24 Jul 2026 11:58 |
| Last Modified | 24 Jul 2026 12:00 |
| Publisher | London School of Hygiene & Tropical Medicine |
Data / Code
MaPs_dataset.zip
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subject - Data
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lock - Restricted to Request access for all
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copyright - Available under Data Sharing Agreement
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info - Participant-level analysis-ready dataset. Access is embargoed until July 2028
folder_zip - application/zip
- folder_info
- 225B
Documentation
MaPs_dataset_codebook.html
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subject - Documentation
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- Available under Creative Commons: Attribution 4.0
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info - Codebook for the MaPs dataset
html - text/html
- folder_info
- 29kB
MaPs_Participant_information_sheet.pdf
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subject - Documentation
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- Available under Creative Commons: Attribution 4.0
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info - Participant Information Sheet (MaPs in ENL randomised controlled trial)
picture_as_pdf - application/pdf
- folder_info
- 267kB
Study Instrument
MaPs_in_ENL_REDCap_collection_form.pdf
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subject - Study Instrument
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- Available under Creative Commons: Attribution 4.0
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info - REDCap data collection form for the MaPs study
picture_as_pdf - application/pdf
- folder_info
- 424kB
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