NCT03775460

Methotrexate and Prednisolone Study in Erythema Nodosum Leprosum

Methotrexate and Prednisolone Study in Erythema Nodosum Leprosum (MaPS in ENL

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 550 (estimated)
• Sponsor: London School of Hygiene and Tropical Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Erythema Nodosum Leprosum (ENL) is a painful, debilitating complication of leprosy. Patients often require high doses of corticosteroids for prolonged periods. Thalidomide is expensive and not available in most countries. The use of corticosteroids for long periods is associated with adverse effects and mortality. It is a priority to identify alternative agents to treat ENL. Methotrexate (MTX) is a cheap, widely used medication which has been reported to be effective in ENL resistant to steroids and thalidomide.

Detailed description

This is a double blind randomized controlled trial (RCT) to test the efficacy of MTX for managing ENL. Patients diagnosed with moderate or severe ENL at ENLIST Group centres in Bangladesh, Brazil, Ethiopia, India, Indonesia and Nepal will be randomly allocated to receive a 15 or 20 mg of oral MTX each week for 48 weeks and prednisolone 40 mg per day reducing to zero over 20 weeks. The control group will receive an identical prednisolone scheme. The participants will be stratified into two groups, those with acute ENL, those with chronic/recurrent ENL. The interventions for both populations are the same, although analysed separately. Adverse effects (AE) will be closely monitored clinically and using laboratory tests. Participants will receive folic acid, 5mg daily for 52 weeks except on the day of MTX to prevent AEs, and nausea will be managed with ondansetron.

Conditions

• Erythema Nodosum Leprosum

Interventions

Type	Name	Description
DRUG	Methotrexate	Participants in the intervention group will receive methotrexate along side prednisolone
DRUG	Placebo	Participants in the control arm will receive placebo along side prednisolone
DRUG	Prednisolone	Participants in both arm will receive prednisolone, which will be the same dosage: 40 mg (initial dose) decreasing dosage for 20 weeks

Timeline

• Start date: 2023-01-15
• Primary completion: 2025-09-01
• Completion: 2025-10-01
• First posted: 2018-12-14
• Last updated: 2025-09-10

Locations

7 sites across 6 countries: Bangladesh, Brazil, Ethiopia, India, Indonesia, Nepal