Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum

Study Overview
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Brief Summary
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Study 2B: Ciclosporin in the management of chronic or recurrent Erythema Nodosum Leprosum Aim: To assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients whose ENL is not controlled with standard Prednisolone. Objective: A pilot double blind controlled study randomizing patients whose ENL is not controlled with standard Prednisolone, and comparing a group treated with Ciclosporin to a group treated with additional steroid only.

Detailed Description
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A pilot double blind controlled study randomizing patients whose ENL is not controlled with standard Prednisolone, and comparing a group treated with Ciclosporin to a group treated with additional steroid only.

Official Title
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A Pilot Double Blind Controlled Study Randomizing Patients Whose ENL is Not Controlled With Standard Prednisolone, and Comparing a Group Treated With Ciclosporin to a Group Treated With Additional Steroid Only.

Conditions
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Leprosy

Intervention / Treatment
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* Drug: prednisolone
* Drug: ciclosporin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals with clinical evidence of recurrent or chronic ENL Aged 18-65 Weigh more than 30Kg Exclusion Criteria: Unwillingness to give informed consent Patients with severe active infections such as tuberculosis Pregnant or breastfeeding women (see Appendix II) Those with renal failure, abnormal renal function, hypertensive Patients taking thalidomide currently or within the last 3 months Patients not willing to return for follow-up Women of reproductive age not willing to use contraception for the duration of the study ( see Appendix II) HIV positive patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ciclosporin<br>ciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks) | Drug: ciclosporin<br>* Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)<br>* Other names: Cyclosporin A;|
| Active Comparator: Prednisolone<br>standard course of prednisolone given in a reducing regimen over 16 weeks | Drug: prednisolone<br>* prednisolone 40mg daily then reducing regimen over 16 weeks<br>* Other names: corticosteroids;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of ENL recurrence episodes per patient |  | up to 32 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean time to ENL recurrence after initial control |  | up to 32 weeks | 
| Severity of ENL at recurrence |  | up to 32 weeks | 
| Amount of additional prednisolone required by patients |  | up to 32 weeks | 
| Frequency of adverse events for patients in each treatment arm |  | up to 32 weeks | 
| Difference in score in Quality of Life assessment between start and end for patients in each treatment arm |  | up to 32 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leprosy, ENL, Erythema Nodosum Leprosum, Prednisolone, Ciclosporin