Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478660
Status:
COMPLETED
Last Update Posted:
2007-10-10
First Post:
2007-05-23
Brief Title:
An Open-Label Study to Evaluate the Response to Adalimumab in Patients With Active Ankylosing Spondylitis Who Have Failed Standard Therapy or TNF-Alpha Inhibitors RHAPSODY
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis - An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-Alpha Inhibitors RHAPSODY
Status:
COMPLETED
Status Verified Date:
2007-10
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:
RHAPSODY
Brief Summary:
Due to the rigor of the clinical development program of adalimumab for the indication of AS the population of subjects with active AS that could enroll in previous phase 3 studies was limited Therefore it is necessary to further evaluate the use of adalimumab in a setting that mimics day-to-day clinical practice to obtain further safety and efficacy data by allowing subjects meeting the characteristics noted below to enter this study
Subjects who failed another TNF inhibitor etanercept infliximab
Subjects with advanced spinal ankylosis
Subjects with AS associated disorders ie uveitis IBD and psoriasis
Subjects who failed another TNF inhibitor etanercept infliximab
Subjects with advanced spinal ankylosis
Subjects with AS associated disorders ie uveitis IBD and psoriasis
Detailed Description:
None
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