Double-blind, Randomized, Placebo-controlled Phase 3 Study of Etanercept in the Treatment of Psoriatic Arthritis and Psoriasis
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First Received Date ICMJE | April 21, 2006 | ||||
Last Updated Date | December 22, 2010 | ||||
Start Date ICMJE | April 2000 | ||||
Primary Completion Date | June 2002 (final data collection date for primary outcome measure) | ||||
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Change History | Complete list of historical versions of study NCT00317499 on ClinicalTrials.gov Archive Site | ||||
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Descriptive Information | |||||
Brief Title ICMJE | Double-blind, Randomized, Placebo-controlled Phase 3 Study of Etanercept in the Treatment of Psoriatic Arthritis and Psoriasis | ||||
Official Title ICMJE | Double-Blind, Randomized, Placebo-Controlled Study of Etanercept (ENBREL) in the Treatment of Psoriatic Arthritis (PsA) and Psoriasis | ||||
Brief Summary | This was a phase 3, double-blind, placebo-controlled, randomized, multicenter study in subjects with psoriatic arthritis (PsA) and psoriasis comprising 3 periods: a 24-week double-blind period, a ≤ 24-week maintenance period, and a 48-week open-label period. During the double-blind period, subjects were randomized equally to 1 of 2 regimens: etanercept 25 mg twice weekly (BIW) or placebo, administered subcutaneously (SC). After the week 24 visit, subjects continued on blind-labeled therapy in a maintenance period until all subjects completed the double-blind period. After the maintenance period, all subjects received open-label etanercept 25 mg BIW. |
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Detailed Description | Previously presented data from 2 double-blind, placebo-controlled trials (Protocols 016.0612 [Investigator IND] and 016.0030 [Immunex IND]) led to the approval of etanercept for reducing clinical signs and symptoms of PsA. One-year radiographic data from Protocol 20021630 led to an additional approval of etanercept for inhibiting structural progression in PsA. Data are used for the following purposes:
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 205 | ||||
Completion Date | July 2002 | ||||
Primary Completion Date | June 2002 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: Subjects had to satisfy the following criteria before randomization into the study:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 70 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
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Administrative Information | |||||
NCT Number ICMJE | NCT00317499 | ||||
Other Study ID Numbers ICMJE | 20021630 | ||||
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Responsible Party | Global Development Leader, Amgen Inc. | ||||
Study Sponsor ICMJE | Amgen | ||||
Collaborators ICMJE | Immunex Corporation | ||||
Investigators ICMJE |
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Information Provided By | Amgen | ||||
Verification Date | December 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |