Ciclosporin in the Management of New Erythema Nodosum Leprosum

NCT00919542 | Completed Phase 2 DMC

• 1 other identifier: ITCRBY24-ENLA
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Leprosy

Keywords

Leprosy; ENL; Erythema Nodosum Leprosum; Prednisolone; Ciclosporin

Outcome Measures

Primary Outcomes (1)

• Number of ENL recurrence episodes per patient

  up to 32 weeks

Secondary Outcomes (4)

• Mean time to ENL recurrence after initial control

  up to 32 weeks

• Amount of additional prednisolone required by patients

  up to 32 weeks

• Frequency of adverse events for patients in each treatment arm

  up to 32 weeks

• Difference in score in Quality of Life assessment between start and end for patients in each treatment arm

  up to 32 weeks

Study Arms (2)

prednisolone

ACTIVE COMPARATOR

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

Drug: prednisolone

Ciclosporin

EXPERIMENTAL

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

Drug: Ciclosporin

Interventions

Ciclosporin DRUG

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

Also known as: cyclosporin, Cyclosporin A

Ciclosporin

prednisolone DRUG

prednisolone 40mg daily then reducing regimen over 16 weeks

Also known as: corticosteroids

prednisolone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with clinical evidence of new ENL
• Aged 18-65
• Weigh more than 30Kg

You may not qualify if:

• 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

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Homes and Hospitals of St Giles: collaborator
• Alert Hospital, Ethiopia: collaborator
• Armauer Hansen Research Institute, Ethiopia: collaborator

Study Sites (1)

Alert Hospital

Addis Ababa, Ethiopia

Location

MeSH Terms

Conditions

Leprosy

Interventions

Cyclosporine; Prednisolone; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Diana NJ Lockwood, MBchB

  London SHTM

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Fellow

Study Record Dates

• First Submitted: June 11, 2009
• First Posted: June 12, 2009
• Study Start: July 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: July 1, 2013
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

ET (1)