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| Name | Class |
|---|---|
| Homes and Hospitals of St Giles | OTHER |
| Alert Hospital, Ethiopia | OTHER |
| Armauer Hansen Research Institute, Ethiopia | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ciclosporin | Experimental | ciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks) |
|
| Prednisolone | Active Comparator | standard course of prednisolone given in a reducing regimen over 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prednisolone | Drug | prednisolone 40mg daily then reducing regimen over 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of ENL recurrence episodes per patient | up to 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diana NJ Lockwood, MBChB | London School of Hygiene and Tropical Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alert Hospital | Addis Ababa | Ethiopia |
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| ID | Term |
|---|---|
| D007918 | Leprosy |
| ID | Term |
|---|---|
| D009165 | Mycobacterium Infections, Nontuberculous |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D000305 | Adrenal Cortex Hormones |
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| ciclosporin | Drug | Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks) |
|
|
| 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 |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |