Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-29 @ 12:09 AM
Study NCT ID:
NCT00478660
Status:
COMPLETED
Last Update Posted:
2007-10-10
First Post:
2007-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
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 (i.e., uveitis, IBD, and psoriasis)
* Subjects who failed another TNF inhibitor (etanercept, infliximab)
* Subjects with advanced spinal ankylosis
* Subjects with AS associated disorders (i.e., uveitis, IBD, and psoriasis)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: