Using Methotrexate and Prednisolone to Treat Erythema Nodosum Leprosum
Methotrexate and Prednisolone Study in Erythema Nodosum Leprosum (MaPS in ENL
This study is testing if the drug Methotrexate can help people with painful Erythema Nodosum Leprosum, a complication of leprosy, when used with a gradually reduced dose of prednisolone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 550 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | London School of Hygiene and Tropical Medicine Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 7 sites (Dhaka and 6 other locations) |
| Trial ID | NCT03775460 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Methotrexate (MTX) in managing Erythema Nodosum Leprosum (ENL), a painful complication of leprosy. Patients diagnosed with moderate to severe ENL will be randomly assigned to receive either MTX or a placebo alongside a tapering dose of prednisolone over 48 weeks. The trial will monitor adverse effects and assess the severity of ENL using a standardized scale. Participants will be recruited from multiple countries, including Bangladesh, Brazil, Ethiopia, India, Indonesia, and Nepal.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18-60 diagnosed with leprosy complicated by moderate to severe ENL.
Not a fit: Patients who have had ENL for more than four years or are currently receiving other anti-ENL treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more affordable alternative for managing ENL, reducing reliance on corticosteroids.
How similar studies have performed: Previous studies have indicated that Methotrexate may be effective for ENL resistant to traditional treatments, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:: ALL OF THE FOLLOWING SIX CRITERIA MUST BE MET IN ORDER FOR AN INDIVIDUAL TO BE ELIGIBLE (ONLY ONE OF 6A TO 6D NEED BE MET): 1. Individuals who diagnosed with leprosy complicated by ENL 2. Individuals with ENL aged 18-60 years old 3. Individuals with ENL deteriorating symptoms 4. Individuals with 10 or more tender, papular or nodular ENL skin lesions 5. Individuals with an EESS score of at least 9 6. Individuals with ENL on: 1. No current anti- ENL treatment 2. Prednisolone up to 30mg per day (if ACUTE) or Prednisolone 10-30mg (inclusive) per day (if RECURRENT/ CHRONIC) or equivalent alternative corticosteroid dose OR 3. Thalidomide or other non-steroidal anti-ENL medication OR 4. A combination of prednisolone (up to 30mg) and another non-steroidal anti-ENL medication (thalidomide, clofazimine, azathioprine, pentoxifylline, ciclosporin, minocycline) Exclusion criteria: 1. Individuals who were first diagnosed with ENL more than 4 years prior to enrolment 2. Individuals less than 18 years old or older than 60 years 3. Individuals weighing less than 35kg 4. Individuals with 9 or fewer tender, popular or nodular ENL skin lesions 5. Individuals with an EESS score of 8 or less 6. Women of child bearing capacity who decline to use two forms of adequate contraception and men who decline to use two forms of adequate contraception 7. Pregnant or breastfeeding women 8. Individuals with recurrent or chronic ENL who deteriorate on a dose of prednisolone less than 10 mg or more than 30 mg 9. Individuals who have taken methotrexate by any route for the last 12 weeks 10. Individuals with a hypersensitivity to methotrexate or a recognised contraindication ( please see Methotrexate information sheet) 11. Individuals currently diagnosed with Type 1 reaction or Lucio's phenomenon 12. Individuals with the severe abnormalities in screening investigations 13. Positive serology for HIV, Hepatitis B or C 14. Evidence of tuberculosis or pulmonary fibrosis 15. A history of chronic liver disease or excessive alcohol or illicit substance consumption 16. Individuals with severe inter-current infections, uncontrolled diabetes, active peptic ulcer disease, untreated malignancy 17. Individuals unable to attend regularly for assessment or monitoring
Where this trial is running
Dhaka and 6 other locations
- TMLI Bangladesh/ DBLM hospital — Dhaka, Bangladesh (Not_yet_recruiting)
- Fiocruz — Rio De Janeiro, Brazil (Not_yet_recruiting)
- Alert — Addis Ababa, Ethiopia (Not_yet_recruiting)
- The Leprosy Mission Trust — Delhi, India (Recruiting)
- Bombay Leprosy Project — Mumbai, India (Recruiting)
- Soetomo Hospital — Surabaya, Indonesia (Not_yet_recruiting)
- Anandaban Hospital — Kathmandu, Nepal (Not_yet_recruiting)
Study contacts
- Principal investigator: Stephen Walker, MD, PhD — London School of Hygiene and Tropical Medicine
- Study coordinator: Barbara de Barros, M.D
- Email: barbara.de-barros@lshtm.ac.uk
- Phone: +44(0)2079272316
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.