NCT00919776

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

2.3 years

First QC Date

June 11, 2009

Last Update Submit

March 25, 2015

Conditions

Leprosy

Keywords

LeprosyENLErythema Nodosum LeprosumPrednisoloneCiclosporin

Outcome Measures

Primary Outcomes (1)

  • number of ENL recurrence episodes per patient

    up to 32 weeks

Secondary Outcomes (5)

  • Mean time to ENL recurrence after initial control

    up to 32 weeks

  • Severity of ENL at recurrence

    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)

ciclosporin

EXPERIMENTAL

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

Drug: ciclosporin

Prednisolone

ACTIVE COMPARATOR

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

Drug: prednisolone

Interventions

prednisoloneDRUG

prednisolone 40mg daily then reducing regimen over 16 weeks

Also known as: corticosteroids
Prednisolone
ciclosporinDRUG

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

Also known as: Cyclosporine, Cyclosporin A
ciclosporin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals with clinical evidence of recurrent or chronic 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alert Hospital

Addis Ababa, Ethiopia

Location

MeSH Terms

Conditions

Leprosy

Interventions

PrednisoloneAdrenal Cortex HormonesCyclosporine

Condition Hierarchy (Ancestors)

Mycobacterium Infections, NontuberculousMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone AntagonistsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Diana NJ Lockwood, MBChB

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

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
SPONSOR

Study Record Dates

First Submitted

June 11, 2009

First Posted

June 12, 2009

Study Start

August 1, 2010

Primary Completion

December 1, 2012

Study Completion

July 1, 2013

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

ET(1)