Spondyloarthritis Clinical Trial
Official title:
Intestinal Inflammation in Ankylosing Spondylitis Assessed by Fecal Calprotectin, Capsular Endoscopy and Colonoscopy and the Effects of Adalimumab on Mucosal Healing
Studies with intestinally asymptomatic patients with spondyloarthritis showed that approximately 1/3 had visible ulcers in the colon by scopic examinations and 2/3 had changes detectable by microscopy. Only those patients who improved in arthritis symptoms showed improvement in colonic changes. In these studies only colon and the terminal ileum was examined. Inflammation of the small intestine was not examined. Newer studies have shown an immunological link between Crohns disease and spondyloarthritis but not ulcerative colitis. The investigators wish to examine the small intestine in these patients before and after treatment, since they expect to find ulcers there linking spondyloarthritis to Crohns disease and healing after treatment.
Patients with inflammatory axial spondyloarthritis according to the assessment group in
ankylosing spondylitis (ASAS) criteria (8) and active disease assessed by a physician are
recruited in the outpatient clinics of the rheumatology departments, provided that the
patient under normal circumstances is expected to benefit from TNF-alpha inhibitor treatment
and full fill the criteria for treatment. Screening with a view to participating in the
study is carried out in accordance with the inclusion and exclusion criteria. Oral and
written patient information about the study, the patient's signing of the informed consent
form and the signing of the patient's power of attorney in accordance with the study
protocol are also a condition for the inclusion. The including physician will ensure that a
potential participant is informed about the right to at least 1 hour's reflection time and
the right to have a friend/family member present at the information interview.
If the patient meets the basis for the participation in the study the informed consent form
and the power of attorney are signed.
The screened patients are not coded but are identified using their Civil Registration Number
(CPR) for several reasons. The study is open-label, which removes the need for blinding of
patients as well as investigator. Blood samples are booked electronically and printed labels
with CPR number are put on the test tubes for both immediate analysis and storage. This
guarantees a more fail-safe method for handling of various analyses, since this procedure is
similar to the routine procedure. We find this to be the safest system as the method, by
which labels with CPR number follow the patient has been thoroughly tested.
Source data will be kept in the Danish Biologics Online Registry (DANBIO registry) for
clinical measures, the electronic patient file for lab data and the paper file for imaging
data. Data validity and completeness is controlled by external "good clinical practice"
monitoring.
Adalimumab will be supplied as a sterile solution without preservatives for subcutaneous
injection in 1 ml prefilled syringes containing adalimumab 40 mg/0.8 ml, to be self-injected
by the patient every 2 weeks until week 20. After week 20 patients continue adalimumab
treatment 40 mg every other week but may change to injections with pens containing the same
drug and dosage. The drug is injected under the skin of the abdomen or the thigh. All
patients will be instructed by the study personnel in correct sterile subcutaneous injection
of the study drug.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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