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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 17, 2004 | ||||
| Last Updated Date | April 10, 2009 | ||||
| Start Date ICMJE | March 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00096928 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study to Evaluate Psoriasis Outcomes and Safety Events in Patients With Chronic Moderate to Severe Plaque Psoriasis (RESPONSE) | ||||
| Official Title ICMJE | Raptiva Epidemiologic Study of Psoriasis Outcomes and Safety Events in Patients With Chronic Moderate to Severe Plaque Psoriasis (RESPONSE) | ||||
| Brief Summary | This is a multicenter, prospective, 5-year surveillance study of approximately 5000 Raptiva-treated patients and approximately 500 non Raptiva treated patients (formerly 2500 comparison patients who were treated with a biologic therapy other than Raptiva) with chronic moderate to severe plaque psoriasis who are candidates for treatment with Raptiva. |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Cohort, Prospective | ||||
| Condition ICMJE | Psoriasis | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 5500 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criterion:
Notes: If you are a doctor who is interested in participating as a study site, contact the RESPONSE Registry hotline for more information. If you are an interested patient, contact your dermatologist (or the doctor treating your psoriasis) regarding this study. A list of participating doctors is below. If your doctor is not listed, then he/she can call the RESPONSE Registry Hotline at 1-800-516-1505 for more information. |
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00096928 | ||||
| Responsible Party | Clinical Trials Posting Group, Genentech, Inc. | ||||
| Study ID Numbers ICMJE | ACD3101g | ||||
| Study Sponsor ICMJE | Genentech | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Genentech | ||||
| Verification Date | April 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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