Methotrexate and Prednisolone Study in Erythema Nodosum Leprosum
NCT ID: NCT03775460
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
550 participants
INTERVENTIONAL
2023-01-15
2025-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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control
Participants will receive placebo+ prednisolone. Participants will start receiving 4 dummy tablets per week, than participants weighing less than 60 kg will receive 6 dummy tablets from week 8. The placebo will be prescribe weekly. Participants weighing 60 kg or more will receive 8 dummy tablets from week 8. Participants will receive dummy tablets for 52 weeks. Along with prednisolone. The start dose of prednisolone will be 40 mg per day decreasing dosage for 20 weeks.
Placebo
Participants in the control arm will receive placebo along side prednisolone
Prednisolone
Participants in both arm will receive prednisolone, which will be the same dosage: 40 mg (initial dose) decreasing dosage for 20 weeks
intervention
Participants will receive Methotrexate(MTX)+prednisolone. All participants in intervention arm will receive an initial dose of MTX 10 mg. The MTX will be increased to 15 mg the following week. Participants weighing less than 60 kg will continue to receive 15 mg of MTX weekly thereafter. Individuals weighing 60 kg or more will receive MTX 20 mg from week 8. At week 48 the MTX will be reduced to 10 mg for two weeks followed by 5 mg for two weeks and then stopped. In total participants will receive 52 weeks of MTX along side prednisolone, which will be the same as the control arm.
Methotrexate
Participants in the intervention group will receive methotrexate along side prednisolone
Prednisolone
Participants in both arm will receive prednisolone, which will be the same dosage: 40 mg (initial dose) decreasing dosage for 20 weeks
Interventions
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Methotrexate
Participants in the intervention group will receive methotrexate along side prednisolone
Placebo
Participants in the control arm will receive placebo along side prednisolone
Prednisolone
Participants in both arm will receive prednisolone, which will be the same dosage: 40 mg (initial dose) decreasing dosage for 20 weeks
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
60 Years
ALL
No
Sponsors
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Dr. Soetomo General Hospital
OTHER_GOV
The Leprosy Mission Trust, India
UNKNOWN
Alert Hospital, Ethiopia
OTHER
The Leprosy Mission Bangladesh
OTHER
Bombay Leprosy Project, India
UNKNOWN
Oswaldo Cruz Foundation
OTHER
Leprosy Research Initiative
UNKNOWN
The Leprosy Mission Nepal
OTHER
London School of Hygiene and Tropical Medicine
OTHER
Responsible Party
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Principal Investigators
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Stephen Walker, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
London School of Hygiene and Tropical Medicine
Locations
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TMLI Bangladesh/ DBLM hospital
Dhaka, , Bangladesh
FIOCRUZ
Rio de Janeiro, , Brazil
ALERT
Addis Ababa, , Ethiopia
The Leprosy Mission Trust
Delhi, , India
Bombay Leprosy Project
Mumbai, , India
Soetomo Hospital
Surabaya, , Indonesia
Anandaban Hospital
Kathmandu, , Nepal
Countries
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References
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Other Identifiers
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15762
Identifier Type: -
Identifier Source: org_study_id
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