Ciclosporin in the Management of New Type 1 Reactions in Leprosy

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Leprosy	Drug: Ciclosporin; Drug: Prednisolone	Phase 2; Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	73 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, 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
Study Start Date :	August 2010
Actual Primary Completion Date :	December 2012
Actual Study Completion Date :	July 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. improvement in nerve function and Clinical Severity Score [ Time Frame: at week 4, 20, 28 ]

Secondary Outcome Measures :

1. Incidence of adverse events [ Time Frame: up to 36 weeks ]
2. Number of T1R recurrence episodes per patient in each treatment arm [ Time Frame: up to 36 weeks ]
3. Severity of T1R recurrence for patients in each treatment arm [ Time Frame: up to 36 weeks ]
4. extra prednisolone needed to control reaction [ Time Frame: up to 36 weeks ]
5. 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 ]
6. Mean time to recurrence of T1R for patients in each treatment arm [ Time Frame: up to 36 weeks ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	June 12, 2009
Last Update Posted:	March 24, 2015
Last Verified:	March 2015

Keywords provided by Saba Lambert, London School of Hygiene and Tropical Medicine:

Leprosy; Type 1 Reactions; Prednisolone; Ciclosporin

Additional relevant MeSH terms:

Leprosy; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Cyclosporins; Cyclosporine; Prednisolone acetate; Methylprednisolone acetate; Prednisolone; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone hemisuccinate; Prednisolone phosphate; Enzyme Inhibitors	Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antifungal Agents; Anti-Infective Agents; Dermatologic Agents; Antirheumatic Agents; Calcineurin Inhibitors; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents