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Ciclosporin in the Management of New Erythema Nodosum Leprosum

Primary Purpose

Leprosy

Status

Completed

Phase

Phase 2

Locations

Ethiopia

Study Type

Interventional

Intervention

Ciclosporin

prednisolone

About this trial

This is an interventional treatment trial for Leprosy focused on measuring Leprosy, ENL, Erythema Nodosum Leprosum, Prednisolone, Ciclosporin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Individuals with clinical evidence of new 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

Active Comparator

Experimental

Arm Label

prednisolone

Ciclosporin

Arm Description

standard course of prednisolone given in a reducing regimen over 16 weeks

ciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks)

Outcomes

Primary Outcome Measures

Number of ENL recurrence episodes per patient

Secondary Outcome Measures

Mean time to ENL recurrence after initial control

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

NCT00919542

First Posted

June 11, 2009

Last Updated

March 21, 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

NCT00919542

Brief Title

Ciclosporin in the Management of New Erythema Nodosum Leprosum

Official Title

A Pilot (Double Blind Controlled) Study Randomizing Patients With New Acute ENL to Treatment Either With Ciclosporin or Prednisolone.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

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 2A: Ciclosporin in the management of new Erythema Nodosum Leprosum Objective: A pilot (double blind controlled) study randomizing patients to treatment either with Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients with new acute Type 2 reactions (ENL).

Detailed Description

A pilot (double blind controlled) study randomizing patients to treatment either with Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients with new acute Type 2 reactions (ENL).

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

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

prednisolone

Arm Type

Active Comparator

Arm Description

standard course of prednisolone given in a reducing regimen over 16 weeks

Arm Title

Ciclosporin

Arm Type

Experimental

Arm Description

ciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks)

Intervention Type

Drug

Intervention Name(s)

Ciclosporin

Other Intervention Name(s)

cyclosporin, Cyclosporin A

Intervention Description

Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)

Intervention Type

Drug

Intervention Name(s)

prednisolone

Other Intervention Name(s)

corticosteroids

Intervention Description

prednisolone 40mg daily then reducing regimen over 16 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

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

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Individuals with clinical evidence of new 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 SHTM

Official's Role

Study Director

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 New Erythema Nodosum Leprosum

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