Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-04-16 @ 12:22 AM
Study NCT ID:
NCT00972218
Status:
WITHDRAWN
Last Update Posted:
2016-09-16
First Post:
2009-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of Spondylitis Related to Inflammatory Bowel Disease
Sponsor:
University of Alberta
Organization:
Study Overview
Official Title:
Efficacy of Adalimumab (Humira®) in Spondyloarthritis Related to Crohn's Disease
Status:
WITHDRAWN
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty with enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Adalimumab is an antibody treatment that targets and neutralizes a molecule produced in the body that is associated with inflammation, tumor necrosis factor (TNF). This molecule is an important factor in causing the inflammation seen in people with a form of inflammatory spinal arthritis called spondylitis as well as inflammation in the bowel called Crohn's disease. Spondylitis and Crohn's disease tend to go together and this study will assess to what degree this treatment is effective for those patients that have both disorders at the same time.
Detailed Description:
The primary objective of the present study is to assess the efficacy of adalimumab in ameliorating the signs and symptoms of spondyloarthritis associated with CD. Although AS patients with IBD were recruited in phase III trials of anti-TNF therapy and shown to respond to treatment, this has not been established in a cohort of patients with exclusive enteropathic spondyloarthritis. Evaluation of such a cohort will address several important issues:
* Firstly, it will answer the question of whether or not patients with enteropathic spondyloarthritis respond to treatment with adalimumab.
* Secondly, since patients with IBD represent a cohort at high risk of developing spondyloarthritis, this approach will allow the study of the efficacy of adalimumab in patients with pre-radiographic inflammatory back pain as determined by clinical, laboratory, and radiological outcomes. In particular, the use of MRI as an outcome measure will be explored. In addition, this will allow the further evaluation of diagnostic criteria for pre-radiographic AS.
* Thirdly, the efficacy of adalimumab in treating IBD associated with SpA has not been previously determined. It has been assumed that the response should be the same as that observed in idiopathic disease. However, it is important to note that the bowel disease related to spondyloarthritis has different genetic associations from idiopathic disease and may have a different underlying pathophysiology. Several biomarkers have been shown to reflect response to anti-TNF therapies in spondyloarthritis e.g. MMP3 and VEGF. However, other surrogates of disease, such as bowel permeability, have yet to be examined.
* Firstly, it will answer the question of whether or not patients with enteropathic spondyloarthritis respond to treatment with adalimumab.
* Secondly, since patients with IBD represent a cohort at high risk of developing spondyloarthritis, this approach will allow the study of the efficacy of adalimumab in patients with pre-radiographic inflammatory back pain as determined by clinical, laboratory, and radiological outcomes. In particular, the use of MRI as an outcome measure will be explored. In addition, this will allow the further evaluation of diagnostic criteria for pre-radiographic AS.
* Thirdly, the efficacy of adalimumab in treating IBD associated with SpA has not been previously determined. It has been assumed that the response should be the same as that observed in idiopathic disease. However, it is important to note that the bowel disease related to spondyloarthritis has different genetic associations from idiopathic disease and may have a different underlying pathophysiology. Several biomarkers have been shown to reflect response to anti-TNF therapies in spondyloarthritis e.g. MMP3 and VEGF. However, other surrogates of disease, such as bowel permeability, have yet to be examined.
Study Oversight
Has Oversight DMC:
False
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?: