Ciclosporin in the Management of New Erythema Nodosum Leprosum

This study has been completed.
Sponsor:
Collaborators:
Homes and Hospitals of St Giles
Alert Hospital, Ethiopia
Armauer Hansen Research Institute, Ethiopia
Information provided by (Responsible Party):
Saba Lambert, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00919542
First received: June 11, 2009
Last updated: March 21, 2015
Last verified: March 2015

June 11, 2009
March 21, 2015
July 2010
December 2012   (final data collection date for primary outcome measure)
Number of ENL recurrence episodes per patient [ Time Frame: up to 32 weeks ] [ Designated as safety issue: No ]
time to relapse of ENL after initial control of symptoms [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00919542 on ClinicalTrials.gov Archive Site
  • Mean time to ENL recurrence after initial control [ Time Frame: up to 32 weeks ] [ Designated as safety issue: No ]
  • Amount of additional prednisolone required by patients [ Time Frame: up to 32 weeks ] [ Designated as safety issue: No ]
  • Frequency of adverse events for patients in each treatment arm [ Time Frame: up to 32 weeks ] [ Designated as safety issue: No ]
  • Difference in score in Quality of Life assessment between start and end for patients in each treatment arm [ Time Frame: up to 32 weeks ] [ Designated as safety issue: No ]
  • time, in hours, to control initial episode of ENL relapse from time of starting anti-reactional medication [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • time, in days, to ENL relapse from date of stopping anti-reactional medication [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Ciclosporin in the Management of New Erythema Nodosum Leprosum
A Pilot (Double Blind Controlled) Study Randomizing Patients With New Acute ENL to Treatment Either With Ciclosporin or Prednisolone.

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).

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Leprosy
  • Drug: Ciclosporin
    Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)
    Other Names:
    • cyclosporin
    • Cyclosporin A
  • Drug: prednisolone
    prednisolone 40mg daily then reducing regimen over 16 weeks
    Other Name: corticosteroids
  • Active Comparator: prednisolone
    standard course of prednisolone given in a reducing regimen over 16 weeks
    Intervention: Drug: prednisolone
  • Experimental: Ciclosporin
    ciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks)
    Intervention: Drug: Ciclosporin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
July 2013
December 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Ethiopia
 
NCT00919542
ITCRBY24-ENLA
Yes
Saba Lambert, London School of Hygiene and Tropical Medicine
London School of Hygiene and Tropical Medicine
  • Homes and Hospitals of St Giles
  • Alert Hospital, Ethiopia
  • Armauer Hansen Research Institute, Ethiopia
Study Director: Diana NJ Lockwood, MBchB London SHTM
London School of Hygiene and Tropical Medicine
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP