Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum

• ClinicalTrials.gov Identifier: NCT00919776
• Recruitment Status: Completed
• First Posted: June 12, 2009
• Last Update Posted: March 26, 2015
• Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: Homes and Hospitals of St Giles; Alert Hospital, Ethiopia; Armauer Hansen Research Institute, Ethiopia
• Information provided by (Responsible Party): London School of Hygiene and Tropical Medicine

Tracking Information

• First Submitted Date: June 11, 2009
• First Posted Date: June 12, 2009
• Last Update Posted Date: March 26, 2015
• Study Start Date: August 2010
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 25, 2015): number of ENL recurrence episodes per patient [ Time Frame: up to 32 weeks ]
• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: March 25, 2015)

• Mean time to ENL recurrence after initial control [ Time Frame: up to 32 weeks ]
• Severity of ENL at recurrence [ Time Frame: up to 32 weeks ]
• Amount of additional prednisolone required by patients [ Time Frame: up to 32 weeks ]
• Frequency of adverse events for patients in each treatment arm [ Time Frame: up to 32 weeks ]
• Difference in score in Quality of Life assessment between start and end for patients in each treatment arm [ Time Frame: up to 32 weeks ]

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.

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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Leprosy

Intervention

• Drug: prednisolone
  prednisolone 40mg daily then reducing regimen over 16 weeks
  Other Name: corticosteroids
• Drug: ciclosporin
  Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)
  Other Names:

  • Cyclosporine
  • Cyclosporin A

Study Arms

• Experimental: ciclosporin
  ciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks)
  Intervention: Drug: ciclosporin
• Active Comparator: Prednisolone
  standard course of prednisolone given in a reducing regimen over 16 weeks
  Intervention: Drug: prednisolone

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 25, 2015): 20
• Original Estimated Enrollment (submitted: June 11, 2009): 12
• Actual Study Completion Date: July 2013
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Ethiopia

Administrative Information

• NCT Number: NCT00919776
• Other Study ID Numbers: ITCCRBY24-ENLB
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: London School of Hygiene and Tropical Medicine
• Study Sponsor: London School of Hygiene and Tropical Medicine

Collaborators

• Homes and Hospitals of St Giles
• Alert Hospital, Ethiopia
• Armauer Hansen Research Institute, Ethiopia

Investigators

• Principal Investigator: Diana NJ Lockwood, MBChB; London School of Hygiene and Tropical Medicine

• PRS Account: London School of Hygiene and Tropical Medicine
• Verification Date: March 2015