Crohn's Disease Clinical Trial
Official title:
Efficacy of Adalimumab (Humira®) in Spondyloarthritis Related to Crohn's Disease
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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