Health Condition 1: A303- Borderline leprosy
Conditions
Interventions
Intervention1: Methotrexate (MTX): Participants will receive Methotrexate (MTX) + prednisolone. All participants in intervention arm will receive via oral route an initial dose of MTX 10 mg. The MTX w
Sponsors
London School of Hygiene and Tropical Medicine
Eligibility
Inclusion criteria
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 to be met): 1. Individuals who diagnosed with leprosy complicated by ENL 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: A. No current anti- ENL treatment B. Prednisolone up to 30mg per day (if ACUTE) or Prednisolone 10-30mg (inclusive) per day (if RECURRENT/ CHRONIC) or equivalent alternative corticosteroid dose OR C. Thalidomide or other non-steroidal anti-ENL medication OR D. A combination of prednisolone (up to 30mg) and another non-steroidal anti-ENL medication (thalidomide, clofazimine, azathioprine, pentoxifylline, ciclosporin, minocycline)
Exclusion criteria
Exclusion criteria: 1) Individuals who were first diagnosed with ENL more than 4 years prior to enrolment 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 Lucioâ??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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| I. Proportion of individuals who have not required additional prednisolone during the first 24 weeks II. Proportion of individuals who have not required additional prednisolone during the first 48 weeks Timepoint: 24 weeks, 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in ENLIST ENL Severity Scale score, baseline to 1st flare of ENL requiring additional prednisolone (PS) 2.Change in health related quality of life at 24, 48, 60 weeks from baseline 3.Proportion of patient, not requiring PS and additional PS in 60 weeks of trial 4.Number of flares of ENL per patient and maximum severity of flares of ENL require additional prednisolone upto 60 weeks 5.Time to 1st flare of ENL after enrolment 6.Proportion of treatment related adverse effects Timepoint: 24,48,60 weeks | — |
Countries
Bangladesh, Brazil, Ethiopia, India, Indonesia, Nepal
Contacts
Public ContactDr Reetika Malik Yadav
Bombay Leprosy Project
Outcome results
None listed