NCT Number: NCT00422617
Evaluate the Efficacy and Safety of One Course of Amevive in Taiwan Patients
An open-label, multicentre study to evaluate the efficacy and safety of one course of weekly intramuscular administration of Amevive in Taiwan patients with chronic plaque psoriasis
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Notify MeKey information
Conditions
Age range
16 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
The purpose of the present study is to establish the efficacy and safety of one course of once weekly 15 mg intramuscular (IM) administration of AMEVIVE in an alternate study population and to address the issue of peak time to response by measuring the proportion of patients achieving a ≥ 75% reduction in PASI at any time after completion of treatment.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Must give written informed consent
- Must be >= 16 years of age
- Must have been diagnosed with chronic plaque psoriasis at least one year and require systemic or phototherapy
- Must have CD4+ lymphocyte count at or above the lower limit of normal
- Must have a BSA >= 10%
Exclusion criteria
- Current erythrodermic, generalized pustular, or guttate psoriasis
- Serious local infection or systemic infection within 3 months prior to the first dose of alefacept
- History of any clinical significant disease that would be contraindicated for this study as determined by the investigator
- Prior history of systemic malignancy, untreated localised skin canceer or a >10 squamous cell carcinoma
- Current enrollment in any other investigational drug study within 30 days prior to study drug administration
- Treatment with systemic immunosuppressant agents within the 4 weeks prior to study drug administration.
Treatment and study plan
Primary outcomes
-
To determine TRR75 of one course of once weekly 15 mg intramuscular (IM) administration of AMEVIVE
Secondary outcomes
-
To determine TRR50, Quality of Life (QOL), the safety and tolerability
Sponsors and collaborators
Lead sponsor
Uni-Pharma
Industry
Collaborators
- Biogen
Registry information
Important dates
- Study start
- 2005
- Study completion
- 2005
- First posted
- Jan 17, 2007
- Registry last updated
- Jan 17, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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