Methotrexate and Prednisolone Study in Erythema Nodosum Leprosum

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.

Conditions

• Erythema Nodosum Leprosum

Interventions

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

Sponsors & Collaborators

• Dr. Soetomo General Hospital

  collaborator OTHER_GOV

• The Leprosy Mission Trust, India

  collaborator UNKNOWN

• Alert Hospital, Ethiopia

  collaborator OTHER

• The Leprosy Mission Bangladesh

  collaborator OTHER

• Bombay Leprosy Project, India

  collaborator UNKNOWN

• Oswaldo Cruz Foundation

  collaborator OTHER

• Leprosy Research Initiative

  collaborator UNKNOWN

• The Leprosy Mission Nepal

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  lead OTHER

Principal Investigators

• Stephen Walker, MD, PhD · London School of Hygiene and Tropical Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-15

Primary Completion

2025-09-01

Completion

2025-10-01

Countries

• Bangladesh
• Brazil
• Ethiopia
• India
• Indonesia
• Nepal

Study Locations