Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum
Primary Purpose
Leprosy
Status
Completed
Phase
Phase 2
Locations
Ethiopia
Study Type
Interventional
Intervention
prednisolone
ciclosporin
Sponsored by
About this trial
This is an interventional treatment trial for Leprosy focused on measuring Leprosy, ENL, Erythema Nodosum Leprosum, Prednisolone, Ciclosporin
Eligibility Criteria
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
Sites / Locations
- Alert Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ciclosporin
Prednisolone
Arm Description
ciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks)
standard course of prednisolone given in a reducing regimen over 16 weeks
Outcomes
Primary Outcome Measures
number of ENL recurrence episodes per patient
Secondary Outcome Measures
Mean time to ENL recurrence after initial control
Severity of ENL at recurrence
Amount of additional prednisolone required by patients
Frequency of adverse events for patients in each treatment arm
Difference in score in Quality of Life assessment between start and end for patients in each treatment arm
Full Information
NCT ID
NCT00919776
First Posted
June 11, 2009
Last Updated
March 25, 2015
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Homes and Hospitals of St Giles, Alert Hospital, Ethiopia, Armauer Hansen Research Institute, Ethiopia
1. Study Identification
Unique Protocol Identification Number
NCT00919776
Brief Title
Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Homes and Hospitals of St Giles, Alert Hospital, Ethiopia, Armauer Hansen Research Institute, Ethiopia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leprosy
Keywords
Leprosy, ENL, Erythema Nodosum Leprosum, Prednisolone, Ciclosporin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ciclosporin
Arm Type
Experimental
Arm Description
ciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks)
Arm Title
Prednisolone
Arm Type
Active Comparator
Arm Description
standard course of prednisolone given in a reducing regimen over 16 weeks
Intervention Type
Drug
Intervention Name(s)
prednisolone
Other Intervention Name(s)
corticosteroids
Intervention Description
prednisolone 40mg daily then reducing regimen over 16 weeks
Intervention Type
Drug
Intervention Name(s)
ciclosporin
Other Intervention Name(s)
Cyclosporine, Cyclosporin A
Intervention Description
Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)
Primary Outcome Measure Information:
Title
number of ENL recurrence episodes per patient
Time Frame
up to 32 weeks
Secondary Outcome Measure Information:
Title
Mean time to ENL recurrence after initial control
Time Frame
up to 32 weeks
Title
Severity of ENL at recurrence
Time Frame
up to 32 weeks
Title
Amount of additional prednisolone required by patients
Time Frame
up to 32 weeks
Title
Frequency of adverse events for patients in each treatment arm
Time Frame
up to 32 weeks
Title
Difference in score in Quality of Life assessment between start and end for patients in each treatment arm
Time Frame
up to 32 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana NJ Lockwood, MBChB
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alert Hospital
City
Addis Abeba
Country
Ethiopia
12. IPD Sharing Statement
Learn more about this trial
Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum
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