Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434044
Status:
COMPLETED
Last Update Posted:
2007-12-13
First Post:
2007-02-09
Brief Title:
Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing Spondylitis
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
Multicenter Double-Blind Placebo-Controlled Randomized Phase III Study of Etanercept in the Treatment of Subjects With Ankylosing Spondylitis
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will represent the sponsors first controlled study of etanercept in Chinese subjects with Ankylosing Spondytitis AS This trial is designed to assess the safety and efficacy of etanercept compared to placebo in the treatment of patients with AS
Detailed Description:
Multicenter double-blind randomized parallel and placebo-controlled outpatient study The study consists of 2 parts part A is a 6-week double-blind treatment period and part B is a 6-week open-label treatment period During part A of the study subjects will be randomly assigned to 1 of 2 treatment regimens 2 etanercept 25 mg or placebo once weekly administered subcutaneously SC After the completion of part A all subjects will receive 2 etanercept 25 mg once weekly The use of placebo as a control in part A is necessary to allow a valid comparison and to provide a quantitative assessment of effect
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None