A study to compare the safety and side effect profile of Thalidomide versus Methotrexate in patients of type 2 Lepra Reactio

Phase 4

• Conditions: Health Condition 1: A305- Lepromatous leprosy

• Registration Number: CTRI/2024/07/070083
• Lead Sponsor: Dr Bhini Ameta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients with severe ENL of any gender and age more than 18 years

2.Patients willing to participate and willing to follow up for six months

Definitions:

Erythema nodosum leprosum (ENL): It is defined as the sudden appearance of transient painful erythematous cutaneous nodules mostly on the extensor aspects of legs and arms, face along with occasional involvement of the trunk.

New ENL: is defined as ENL occurring 1st time in a patient.

Nature of ENL classified as:

Acute ENL- one ENL episode lasting for less than 24 weeks while the patient is on corticosteroid treatment.

Recurrent ENL- if a patient develops ENL again after 28 days of stoppage of treatment.

Chronic ENL- ENL lesions persist for greater than or 24 weeks while the patient is on treatment continuously/having treatment free period for 27 days or less

Mild ENL: It affects only the skin along with low grade fever and ENLIST ENL severity score is less than or equal to 8.

Severe ENL: It is characterized by multiple cutaneous nodules which may ulcerate, along with the inflammation of other organs such as the nerves, eyes, joints, testes, and lymph nodes. The ENLIST ENL score more than 8.

Exclusion Criteria

1.Patients with known immunosuppression or on immunosuppressive therapy

2.Patients with severe ENL on any steroid-sparing agents within the last one month

3.Pregnancy and lactation

4.Patients with a history of hypersensitivity to thalidomide or methotrexate.

5.Patients with haemoglobin less than 10 gm/dl, Leukopenia (total leukocyte count less than 4000/mm3), or thrombocytopenia (Platelets less than 1lakh/mm3), active liver disease (AST, ALT more han 35 IU/L), eGFR less than 30 ml/min/1.73 m2

6.Patients with HIV 1 and or 2, Hepatitis B and C infection.

7.Patients on therapy that interacts with interventional drugs

8.Patients with a self-declared history of alcohol consumption.

9.Patients who will deny giving consent to the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified