Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in ENL

NCT07806357 | Completed Phase 1

• 1 other identifier: CMC/PG/2018/447
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leprosy

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  01.06.2018 to 31.12.2019 total 18 months

Study Arms (2)

oral Prednisolone alone

EXPERIMENTAL

10 patient

Drug: Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction)

oral Methotrexate plus Prednisol

EXPERIMENTAL

9 patient

Drug: Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction)

Interventions

Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction) DRUG

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.

oral Methotrexate plus Prednisol; oral Prednisolone alone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with ENL had crops of tender subcutaneous skin lesions with systemic features including fever (temperature \>38°C), neuritis, joint pain, bone tenderness, orchitis, iritis, oedema, malaise, anorexia and lymphadenopathy.
• Patients of both sexes with age ranging 18 years to 65 years.

You may not qualify if:

• Erythema nodosum associated with other disorder.
• Pregnant and lactating women.
• Diagnosed case of chronic hepatic, renal, hematological or other connective tissue disorders, Osteoporosis.
• Severely ill, immune-suppressed patients like HIV/AIDS and patients of internal malignancy.
• Patients or guardians not willing to participate in the study by signing informed consent form.

Sponsors & Collaborators

• Chittagong Medical College: lead
• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: collaborator

Study Sites (1)

Chittagong Medical College

Chittagong, 4203, Bangladesh

Location

Related Links

• Using methotrexate to treat patients with ENL unresponsive to steroids and clofazimine: a report on 9 patients
• Effectiveness of Methotrexate in prednisolone and thalidomide resistant cases of Type 2 lepra reaction: report on three cases
• Methotrexate in resistant ENL
• A scale to assess the severity of leprosy reactions
• ENLIST 1: An International Multi-centre Cross-sectional Study of the Clinical Features of Erythema Nodosum Leprosum
• Leprosy reactions in postelimination stage: the Bangladesh experience

MeSH Terms

Conditions

Leprosy

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MBBS, MD, PHD

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: September 8, 2026
• Study Start: June 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year
• Access Criteria: Doctors

Locations

BA (1)