Methotrexate and Prednisolone Study in Erythema Nodosum Leprosum (MaPS in ENL

Status: Active_not_recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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 available in most countries. The use of corticosteroids for long periods is associated with adverse effects and mortality. It is a priority to identify alternative agents to treat ENL. Methotrexate (MTX) is a cheap, widely used medication which has been reported to be effective in ENL resistant to steroids and thalidomide.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Bangladesh
TMLI Bangladesh/ DBLM hospital
Dhaka
Brazil
FIOCRUZ
Rio De Janeiro
Ethiopia
ALERT
Addis Ababa
India
The Leprosy Mission Trust
Delhi
Bombay Leprosy Project
Mumbai
Indonesia
Soetomo Hospital
Surabaya
Nepal
Anandaban Hospital
Kathmandu
Time Frame
Start Date: 2023-01-15
Completion Date: 2025-10-01
Participants
Target number of participants: 550
Treatments
Placebo_comparator: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Oswaldo Cruz Foundation, The Leprosy Mission Nepal, Alert Hospital, Ethiopia, Bombay Leprosy Project, India, The Leprosy Mission Trust, India, The Leprosy Mission Bangladesh, Leprosy Research Initiative, Dr. Soetomo General Hospital
Leads: London School of Hygiene and Tropical Medicine

This content was sourced from clinicaltrials.gov