Ciclosporin in the Management of New Type 1 Reactions in Leprosy

Study Overview
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Brief Summary
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Study 1A: Ciclosporin in the management of new Type 1 Reactions in Leprosy Objective: A randomised double blind controlled trial comparing Ciclosporin and Prednisolone,to determine whether treatment with Ciclosporin gives the same outcome in the treatment of new Type 1 Reactions as Prednisolone.

Detailed Description
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We tested our hypothesis that ciclosporin would be as effective as prednisolone in the treatment of patients with leprosy reactions and nerve function impairment and that patients treated with ciclosporin would have fewer side effects than patients treated with prednisolone. A randomised controlled trial comparing ciclosporin and prednisolone in the treatment of acute leprosy T1R was conducted.

Official Title
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A Randomised Double Blind Controlled Trial Comparing Ciclosporin and Prednisolone in the Treatment of New Leprosy Type 1 Reactions

Conditions
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Leprosy

Intervention / Treatment
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* Drug: Ciclosporin
* Drug: Prednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals with clinical evidence of T1R with new nerve function impairment (NFI). 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 arm<br>ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks) | Drug: Ciclosporin<br>* Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)<br>* Other names: Cyclosporine A;|
| Active Comparator: prednisolone<br>standard course of prednisolone given in a reducing regimen over 24 weeks | Drug: Prednisolone<br>* prednisolone 40mg daily then reducing regimen over 24 weeks<br>* Other names: corticosteroids;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in nerve function and Clinical Severity Score |  | at week 4, 20, 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | up to 36 weeks | 
| Number of T1R recurrence episodes per patient in each treatment arm |  | up to 36 weeks | 
| Severity of T1R recurrence for patients in each treatment arm |  | up to 36 weeks | 
| extra prednisolone needed to control reaction |  | up to 36 weeks | 
| 6. Difference in score in Quality of Life assessment between start and end of treatment for patients in each treatment arm |  | 36 weeks | 
| Mean time to recurrence of T1R for patients in each treatment arm |  | up to 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leprosy, Type 1 Reactions, Prednisolone, Ciclosporin