Methotrexate and Prednisolone Study in Erythema Nodosum Leprosum

Launched by LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE · Dec 13, 2018

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called methotrexate to treat Erythema Nodosum Leprosum (ENL), a painful skin condition that can occur in people with leprosy. ENL often requires long-term treatment with corticosteroids, which can have serious side effects. Methotrexate is a more affordable option that may help patients who do not respond well to steroids or thalidomide, another treatment that is often not available in many places.

To participate in this trial, individuals need to be between 18 and 60 years old and have a diagnosis of leprosy complicated by ENL. They should have at least 10 painful skin lesions or worsening symptoms despite current treatments. Participants can expect regular assessments and monitoring throughout the study. It’s important to know that certain people, like those with other serious health conditions or who are pregnant, will not be eligible for this trial.

Gender

ALL

Eligibility 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 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:
• • 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:
• • 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 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