Intestinal Inflammation in Ankylosing Spondylitis and the Effects of Adalimumab on Mucosal Healing
Condition: Spondyloarthritis; Enterocolitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Enterocolitis; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Adalimumab
Intervention type(s): Drug
Intervention description(s): Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given
Other intervention name(s): Humira
Intervention MeSH terms: Adalimumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic