Double-blind, Randomized, Placebo-controlled Phase 3 Study of Etanercept in the Treatment of Psoriatic Arthritis and Psoriasis
|ClinicalTrials.gov Identifier: NCT00317499|
Recruitment Status : Completed
First Posted : April 25, 2006
Last Update Posted : December 23, 2010
|Condition or disease||Intervention/treatment||Phase|
|Psoriatic Arthritis Psoriasis||Other: Placebo Drug: Etanercept||Phase 3|
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:
- To summarize the clinical efficacy and safety results previously described in the 6-month clinical study report and the radiographic results previously described in the 1-year clinical study report.
- To show the effect of etanercept on physical function in subjects with PsA and psoriasis, as measured by 2 patient-reported outcome measures (disability index of the Stanford Health Assessment Questionnaire [HAQ] and Medical Outcomes Study Short-form Health Survey [SF-36]). • To present the radiographic results at 2 years from baseline and the final clinical efficacy and safety results during the open-label period of the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||205 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Double-Blind, Randomized, Placebo-Controlled Study of Etanercept (ENBREL) in the Treatment of Psoriatic Arthritis (PsA) and Psoriasis|
|Study Start Date :||April 2000|
|Primary Completion Date :||June 2002|
|Study Completion Date :||July 2002|
U.S. FDA Resources
|Placebo Comparator: Placebo||
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317499