Methotrexate and Prednisolone Study in Erythema Nodosum Leprosum

NAActive, not recruitingINTERVENTIONAL
Enrollment

550

Participants

Timeline

Start Date

January 15, 2023

Primary Completion Date

September 1, 2025

Study Completion Date

October 1, 2025

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

Trial Locations (7)

Unknown

TMLI Bangladesh/ DBLM hospital, Dhaka

FIOCRUZ, Rio de Janeiro

ALERT, Addis Ababa

The Leprosy Mission Trust, Delhi

Bombay Leprosy Project, Mumbai

Soetomo Hospital, Surabaya

Anandaban Hospital, Kathmandu

All Listed Sponsors
collaborator

Dr. Soetomo General Hospital

OTHER_GOV

collaborator

The Leprosy Mission Trust, India

UNKNOWN

collaborator

Alert Hospital, Ethiopia

OTHER

collaborator

The Leprosy Mission Bangladesh

OTHER

collaborator

Bombay Leprosy Project, India

UNKNOWN

collaborator

Oswaldo Cruz Foundation

OTHER

collaborator

Leprosy Research Initiative

UNKNOWN

collaborator

The Leprosy Mission Nepal

OTHER

lead

London School of Hygiene and Tropical Medicine

OTHER