Status:
COMPLETED
Intestinal Inflammation in Ankylosing Spondylitis and the Effects of Adalimumab on Mucosal Healing
Lead Sponsor:
Regionshospitalet Silkeborg
Collaborating Sponsors:
Abbott
Medtronic - MITG
Conditions:
Spondyloarthritis
Enterocolitis
Eligibility:
All Genders
18-45 years
Phase:
PHASE4
Brief 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...
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 outpa...
Eligibility Criteria
Inclusion
- Patients (18 years and ≤45 years) with axial SpA according to the ASAS criteria
- Active SpA assessed by physician.
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4.
- Faecal calprotectin ≥ 100mg/kg.
- Negative pregnancy test (serum-HCG) for women of childbearing age before the start of the study. (Women not of childbearing age are defined as postmenopausal for at least 1 year or surgically sterilised (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)). Women of childbearing age included in the study will be required to use contraception during the entire study period (i.e. one of the following: contraceptive pills, intrauterine device, depot injection of gestagen, subdermal implant, hormonal vaginal ring or transdermal patch). In addition, contraception must be used following any discontinuation of the study drug for a period of 150 days.
- Ability and willingness to self-administer the subcutaneous injections or have a person available to administer the injections.
- Ability and willingness to give written informed consent and meet the requirements of the study protocol.
Exclusion
- Diagnosed inflammatory bowel disease or high risk of intestinal stricture (previous abdominal stricture, radiation of abdomen, major abdominal surgery).
- Non steroid anti inflammatory Drugs (NSAID) ingestion less than 4 weeks before inclusion.
- Psoriasis
- Persons with latent Tuberculosis (TB)(positive Mantoux skin test (\>10 mm), positive cultivation for mycobacteria in tissue samples and/or chest X-ray indicating TB) or other risk factors for activation of untreated latent TB.
- Current or recurrent infections or serious infections requiring hospitalisation or treatment with intravenous antibiotics within the last 30 days or oral antibiotics within the last 14 days before inclusion.
- Positive serology for Hepatitis B or C indicating active infection.
- Medical history of positive HIV status (in case of suspicion control of HIV test).
- Medical history of histoplasmosis or listeriosis.
- Previous cancer or lymphoid proliferative disease except completely well-treated cutaneous squamous cell carcinoma, basal cell carcinoma or cervical dysplasia.
- Previous diagnosis or signs of demyelinising diseases of the central nervous system (e.g. optic neuritis, disturbance of vision, disturbed gait/ataxia, facial paresis, apraxia).
- Severe renal insufficiency (creatinine clearance \< 35 ml/min - normogram).Affected hepatic function: Liver enzymes \> 3 x above the normal limit.
- Clinically significant drug or alcohol abuse in the last year or daily current alcohol consumption.
- Diabetes, unstable ischemic heart disease, heart failure (NYHA III-IV), recent apoplexia cerebri (within 3 months), chronic leg ulcer and any other condition (e.g. indwelling catheter) which at the discretion of the investigator means that participation in the protocol would entail a risk for the person in question.
- Anticoagulant treatment.
- Pregnancy or breast-feeding.
- Other clinically significant inflammatory rheumatologic diseases that cannot be related to spondyloarthritis
- Current parvovirus B 19 infection.
- Glucocorticosteroid treatment within the last 4 weeks (except nasal and inhalation steroids).
- Contraindication to study drug.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01174186
Start Date
October 1 2010
End Date
March 1 2014
Last Update
December 2 2014
Active Locations (4)
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1
Department of Rheumatology U, Aarhus Hospital
Aarhus, Denmark, 8000
2
Regional Hospital of Horsens, Department of Medicine
Horsens, Denmark, 8700
3
Regional Hospital of Randers, Department of Medicine
Randers, Denmark
4
Regional Hospital of Silkeborg
Silkeborg, Denmark, 8600