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.
Primary Outcome Measures:
- improvement in nerve function and Clinical Severity Score [ Time Frame: at week 4, 20, 28 ]
Secondary Outcome Measures:
- Incidence of adverse events [ Time Frame: up to 36 weeks ]
- Number of T1R recurrence episodes per patient in each treatment arm [ Time Frame: up to 36 weeks ]
- Severity of T1R recurrence for patients in each treatment arm [ Time Frame: up to 36 weeks ]
- extra prednisolone needed to control reaction [ Time Frame: 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 [ Time Frame: 36 weeks ]
- Mean time to recurrence of T1R for patients in each treatment arm [ Time Frame: up to 36 weeks ]
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| Enrollment: |
73 |
| Study Start Date: |
August 2010 |
| Study Completion Date: |
July 2013 |
| Primary Completion Date: |
December 2012 (Final data collection date for primary outcome measure) |
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Experimental: ciclosporin arm
ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks)
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Drug: Ciclosporin
Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)
Other Names:
- Cyclosporine
- Cyclosporine A
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Active Comparator: prednisolone
standard course of prednisolone given in a reducing regimen over 24 weeks
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Drug: Prednisolone
prednisolone 40mg daily then reducing regimen over 24 weeks
Other Name: corticosteroids
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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.
