Double-blind, Randomized, Placebo-controlled Phase 3 Study of Etanercept in the Treatment of Psoriatic Arthritis and Psoriasis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|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|
|Study Completion Date:||July 2002|
|Primary Completion Date:||June 2002 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||
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.