Ciclosporin in the Management of New Type 1 Reactions in Leprosy

Overview

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.

Full Title of Study: “A Randomised Double Blind Controlled Trial Comparing Ciclosporin and Prednisolone in the Treatment of New Leprosy Type 1 Reactions”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2012

Detailed Description

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.

Interventions

  • Drug: Ciclosporin
    • Ciclosporin 7.5mg/kg – reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)
  • Drug: Prednisolone
    • prednisolone 40mg daily then reducing regimen over 24 weeks

Arms, Groups and Cohorts

  • Experimental: ciclosporin arm
    • ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks)
  • Active Comparator: prednisolone
    • standard course of prednisolone given in a reducing regimen over 24 weeks

Clinical Trial Outcome Measures

Primary Measures

  • improvement in nerve function and Clinical Severity Score
    • Time Frame: at week 4, 20, 28

Secondary 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • London School of Hygiene and Tropical Medicine
  • Collaborator
    • Homes and Hospitals of St Giles
  • Provider of Information About this Clinical Study
    • Principal Investigator: Saba Lambert, Clinical Research Fellow – London School of Hygiene and Tropical Medicine
  • Overall Official(s)
    • Diana Lockwood, MBChB, Principal Investigator, London School of Hygiene and Tropical Medicine

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