Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum

Leprosy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919776
• Other study ID #: ITCCRBY24-ENLB
• Status: Completed
• Phase: Phase 2
• First received: June 11, 2009
• Last updated: March 25, 2015
• Start date: August 2010
• Est. completion date: July 2013

Study information

• Verified date: March 2015
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: London School of Hygiene and Tropical Medicine Ethics CommitteeEthiopia: AHRI/ALERT Ethical Review CommitteeEthiopia: National Science and Technology Committee of EthiopiaEthiopia: Drug Administration and Control Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leprosy

Intervention

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

Locations

Country	Name	City	State
Ethiopia	Alert Hospital	Addis Abeba

Sponsors (4)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Alert Hospital, Ethiopia, Armauer Hansen Research Institute, Ethiopia, Homes and Hospitals of St Giles

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of ENL recurrence episodes per patient		up to 32 weeks	No
Secondary	Mean time to ENL recurrence after initial control		up to 32 weeks	No
Secondary	Severity of ENL at recurrence		up to 32 weeks	No
Secondary	Amount of additional prednisolone required by patients		up to 32 weeks	No
Secondary	Frequency of adverse events for patients in each treatment arm		up to 32 weeks	No
Secondary	Difference in score in Quality of Life assessment between start and end for patients in each treatment arm		up to 32 weeks	No