The Efficacy and Safety of Thalidomide versus Methotrexate in Erythema Nodosum Leprosum (ENL): A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- To compare the proportion of patients achieving remission at three and six months (Remission is defined as subsidence of all features of ENL with ENL International Study Group Severity Scale score of zero when the patient is off prednisolone or minimal prednisolone dose of 10mg or less) between the Thalidomide group and Methotrexate group
研究概览
简要总结
This is a single-blinded, randomized, controlled, non-inferiority trial being conducted at a tertiary care institute in Eastern India. The primary objective of this trial is to assess the safety and efficacy of methotrexate in erythema nodosum leprosum and compare it with thalidomide. A total of 46 patients meeting the inclusion and exclusion criteria will be recruited and randomized into two groups (23 each) using computer-generated randomization sequences. One group will receive oral methotrexate with prednisolone, and another group will receive oral thalidomide with prednisolone. Both the groups will be followed up for a period of 6 months and will be assessed for response to treatment (using EESS score) and adverse effects of the drugs, if any. Routine lab monitoring will be done as per protocol. Data will be recorded in hard copy in the form of pre-designed proforma and soft copy in the form of an Excel sheet. Statistical analysis will be done using SPSS software version 27.
Approval is taken from the Institute Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar. Informed consent will be taken from all participants and the study will follow ICMR and GCP guidelines
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •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
- •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.
排除标准
- •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.
结局指标
主要结局
To compare the proportion of patients achieving remission at three and six months (Remission is defined as subsidence of all features of ENL with ENL International Study Group Severity Scale score of zero when the patient is off prednisolone or minimal prednisolone dose of 10mg or less) between the Thalidomide group and Methotrexate group
时间窗: Baseline, 3 month, 6 month
次要结局
- i. The number of ENL flares(ii. The mean time for ENL flare)
研究者
Dr Bhini Ameta
All India Institute of Medical Sciences, Bhubaneswar