Ciclosporin in the Management of New Type 1 Reactions in Leprosy

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:
NCT00919815
First received: June 11, 2009
Last updated: March 21, 2015
Last verified: March 2015
  Purpose

Study 1A: Ciclosporin in the management of new Type 1 Reactions in Leprosy

Objective: A randomised double blind controlled trial comparing Ciclosporin and Prednisolone,to determine whether treatment with Ciclosporin gives the same outcome in the treatment of new Type 1 Reactions as Prednisolone.


Condition Intervention Phase
Leprosy
Drug: Ciclosporin
Drug: Prednisolone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised Double Blind Controlled Trial Comparing Ciclosporin and Prednisolone in the Treatment of New Leprosy Type 1 Reactions

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • improvement in nerve function and Clinical Severity Score [ Time Frame: at week 4, 20, 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: up to 36 weeks ] [ Designated as safety issue: Yes ]
  • Number of T1R recurrence episodes per patient in each treatment arm [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]
  • Severity of T1R recurrence for patients in each treatment arm [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]
  • extra prednisolone needed to control reaction [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]
  • 6. Difference in score in Quality of Life assessment between start and end of treatment for patients in each treatment arm [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • Mean time to recurrence of T1R for patients in each treatment arm [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: August 2010
Study Completion Date: July 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ciclosporin arm
ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks)
Drug: Ciclosporin
Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)
Other Names:
  • Cyclosporine
  • Cyclosporine A
Active Comparator: prednisolone
standard course of prednisolone given in a reducing regimen over 24 weeks
Drug: Prednisolone
prednisolone 40mg daily then reducing regimen over 24 weeks
Other Name: corticosteroids

Detailed Description:

We tested our hypothesis that ciclosporin would be as effective as prednisolone in the treatment of patients with leprosy reactions and nerve function impairment and that patients treated with ciclosporin would have fewer side effects than patients treated with prednisolone. A randomised controlled trial comparing ciclosporin and prednisolone in the treatment of acute leprosy T1R was conducted.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals with clinical evidence of T1R with new nerve function impairment (NFI).
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919815

Locations
Ethiopia
Alert Hospital
Addis Abeba, Ethiopia
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Homes and Hospitals of St Giles
Alert Hospital, Ethiopia
Armauer Hansen Research Institute, Ethiopia
Investigators
Principal Investigator: Diana Lockwood, MBChB London School of Hygiene and Tropical Medicine
  More Information

No publications provided

Responsible Party: Saba Lambert, Clinical Research Fellow, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00919815     History of Changes
Other Study ID Numbers: ITCRBY24-T1RA
Study First Received: June 11, 2009
Last Updated: March 21, 2015
Health Authority: United Kingdom: London School of Hygiene and Tropical Medicine Ethics Committee
Ethiopia: AHRI/ALERT Ethical Review Committee
Ethiopia: National Science and Technology Committee of Ethiopia
Ethiopia: Drug Administration and Control Authority

Keywords provided by London School of Hygiene and Tropical Medicine:
Leprosy
Type 1 Reactions
Prednisolone
Ciclosporin

Additional relevant MeSH terms:
Leprosy
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Cyclosporine
Cyclosporins
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antifungal Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Autonomic Agents
Central Nervous System Agents
Dermatologic Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors

ClinicalTrials.gov processed this record on March 25, 2015