A Phase 1 interventional study of Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction) in Leprosy, sponsored by Chittagong Medical College. Completed at 1 site in Bangladesh. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Chittagong Medical College · Phase 1, Interventional, and Treatment
Erythema nodosum leprosum (ENL) is characterized by painful nodules and systemic compromising. It is usually recurrent and/or chronic and has both physical and economic impact on the patient, being a very important cause of morbidity and mortality. In addition, ENL is a major health problem in developing countries like Bangladesh where leprosy is endemic. Therefore, adequate control of this condition is important to reduce morbidity and mortality.
The treatment of ENL is usually started with steroids which have many adverse effects when given for prolonged periods and in high doses. However, recently in some case reports MTX appears to have a beneficial effect in cases of ENL. Also, MTX may provide a cheaper and convenient option in management of ENL.
However, there is paucity of well-designed randomized controlled trial on the effectiveness of MTX in the treatment of ENL. In this context such studies are needed. The investigator therefore designed this randomize trial to evaluate the efficacy and safety of combined MTX and Prednisolone over Prednisolone monotherapy in local setting. The investigator combined reducing doses of Prednisolone with a low dose MTX to minimize dose related complications, while maximizing benefit in controlling ENL. If the study results would show the superiority of combined regimen as found elsewhere in the World, it would be helpful to reduce the morbidity of ENL Patients.
52 studies on the registry are indexed under Leprosy; 13 are open to participants now.
This study's enrollment of 19 is below the median of 70 across 41 interventional studies indexed under Leprosy.
Browse Leprosy studies →Chittagong Medical College is the lead sponsor of 15 studies on the registry; 8 are open to participants now.
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
10 patient
Drug: Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction)
9 patient
Drug: Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction)
For Group A: Each of the selected patients of group A received Tablet Methotrexate 2.5 mg 3 doses (12 hour apart), 7.5mg per week for 6 months and Tablet Prednisolone (40mg/day) tapering over 3 months. Reducing 5 mg of prednisolone every 2 weekly up to 20 mg/day then 5 mg every week for 1 month. And Methotrexate was used 7.5 mg weekly as maintenance dose. For Group B: Patients of group B received Prednisolone (40mg/day) tapering over 6 months. Reducing 5 mg every 2 weeks up to 20 mg (2 months) then 20 mg continued for 10 weeks. Then reduced 5 mg every 2 weeks up to 24 weeks.
Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction)
Primary outcome: Improvement in Reaction severity assessment score by observing signs and symptoms like tender skin ENL nodules.
Time frame: 01.06.2018 to 31.12.2019 total 18 months
Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction)
Primary outcome: Improvement in Reaction severity by Physicians Global Assessment changes in number of tender Erythema Nodosum Leprosum skin nodules
Time frame: 01.06.2018 to 31.12.2019 total 18 months
Plan to share: Yes — Data
Supporting information: Study protocol
Time frame: 1 year
Access criteria: Doctors
Ran from Jun 2018 to primary completion in Dec 2019, 18 months.
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Chittagong Medical College