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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00050648 |
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Date of registration:
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17/12/2002 |
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Primary sponsor: |
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Public title:
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To Study the Effects of CD25 and Low Dose Cyclosporin in the Treatment of Active Psoriasis Vulgaris
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Scientific title:
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Use of Humanized CD25 (Anti-TAC) Monoclonal Antibody and Cyclosporine for the Treatment of Active Psoriasis. |
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Date of first enrolment:
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October 1997 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00050648 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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James Krueger, MD, PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rockefeller University |
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Key inclusion & exclusion criteria
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Inclusion criteria
1. Male or female patients with chronic psoriasis vulgaris (disease stable or worsening
for > 6 months). Patients age 16 - 21 will be considered on a case by case basis.
Patients below 18 will need parental consent.
2. Extensive skin involvement.
3. Scale, thickness, and erythema in individual psoriasis lesions of at least intensity.
4. Psoriasis treated with emollients only for 2 weeks prior to treatment
5. Patients with active psoriatic arthritis, if accompanied by psoriasis vulgaris
involving more than 5% of the body surface.
6. History of psoriasis that cannot be treated with topical agents or with previous
systemic/ photo(chemo)therapy agents.
Exclusion Criteria:
1. . Positive serology for HIV, Hepatitis B, or Hepatitis C.
2. . Positive ß-HCG titer. For women of childbearing potential, unwillingness or
inability to use a contraceptive device during this study if negative for ß-HCG.
3. Guttate psoriasis, pustular psoriasis, or whole body erythroderma.
4. Active infection or persistent fever of unknown origin. 5.) Major concurrent illness,
which could worsen following treatment with DaclizumabTM.
6) Any history of an un-treated neoplasm
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Psoriasis
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Intervention(s)
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Drug: Cyclosporine
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Drug: cyclosporine and Daclizumab
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Drug: Daclizumab
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Primary Outcome(s)
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clinical tolerability of DaclizumabTM and the DaclizumabTM/cyclosporine combination
[Time Frame: day 1, week 1, 2, 3, 4, 5,7,8,9,11, 12, 13, 14]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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