Status:
ACTIVE_NOT_RECRUITING
Methotrexate and Prednisolone Study in Erythema Nodosum Leprosum
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
Dr. Soetomo General Hospital
The Leprosy Mission Trust, India
Conditions:
Erythema Nodosum Leprosum
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 availab...
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, Eth...
Eligibility Criteria
Inclusion
- 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):
- Individuals who diagnosed with leprosy complicated by ENL
- Individuals with ENL aged 18-60 years old
- Individuals with ENL deteriorating symptoms
- Individuals with 10 or more tender, papular or nodular ENL skin lesions
- Individuals with an EESS score of at least 9
- Individuals with ENL on:
- No current anti- ENL treatment
- Prednisolone up to 30mg per day (if ACUTE) or Prednisolone 10-30mg (inclusive) per day (if RECURRENT/ CHRONIC) or equivalent alternative corticosteroid dose OR
- Thalidomide or other non-steroidal anti-ENL medication OR
- A combination of prednisolone (up to 30mg) and another non-steroidal anti-ENL medication (thalidomide, clofazimine, azathioprine, pentoxifylline, ciclosporin, minocycline)
- Exclusion criteria:
- Individuals who were first diagnosed with ENL more than 4 years prior to enrolment
- Individuals less than 18 years old or older than 60 years
- Individuals weighing less than 35kg
- Individuals with 9 or fewer tender, popular or nodular ENL skin lesions
- Individuals with an EESS score of 8 or less
- 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
- Pregnant or breastfeeding women
- Individuals with recurrent or chronic ENL who deteriorate on a dose of prednisolone less than 10 mg or more than 30 mg
- Individuals who have taken methotrexate by any route for the last 12 weeks
- Individuals with a hypersensitivity to methotrexate or a recognised contraindication ( please see Methotrexate information sheet)
- Individuals currently diagnosed with Type 1 reaction or Lucio's phenomenon
- Individuals with the severe abnormalities in screening investigations
- Positive serology for HIV, Hepatitis B or C
- Evidence of tuberculosis or pulmonary fibrosis
- A history of chronic liver disease or excessive alcohol or illicit substance consumption
- Individuals with severe inter-current infections, uncontrolled diabetes, active peptic ulcer disease, untreated malignancy
- Individuals unable to attend regularly for assessment or monitoring
Exclusion
Key Trial Info
Start Date :
January 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT03775460
Start Date
January 15 2023
End Date
October 1 2025
Last Update
September 10 2025
Active Locations (7)
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1
TMLI Bangladesh/ DBLM hospital
Dhaka, Bangladesh
2
FIOCRUZ
Rio de Janeiro, Brazil
3
ALERT
Addis Ababa, Ethiopia
4
The Leprosy Mission Trust
Delhi, India