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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT01174186
Date of registration: 16/07/2010
Prospective Registration: Yes
Primary sponsor: Regionshospitalet Silkeborg
Public title: Intestinal Inflammation in Ankylosing Spondylitis and the Effects of Adalimumab on Mucosal Healing INTASAH
Scientific title: Intestinal Inflammation in Ankylosing Spondylitis Assessed by Fecal Calprotectin, Capsular Endoscopy and Colonoscopy and the Effects of Adalimumab on Mucosal Healing
Date of first enrolment: October 2010
Target sample size: 30
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01174186
Study type:  Interventional
Study design:   
Phase:  Phase 4
Countries of recruitment
Denmark
Contacts
Name:     Bent Deleuran, M.D.
Address: 
Telephone:
Email:
Affiliation:  Department of Medical Microbiology and Immunology Aarhus University
Name:     Henning Glerup, M.D.
Address: 
Telephone:
Email:
Affiliation:  Regional Hospital Silkeborg, medical department
Name:     RenĂ© D Oestgaard, M.D.
Address: 
Telephone:
Email:
Affiliation:  Regional Hospital Silkeborg, medical department
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: All
Health Condition(s) or Problem(s) studied
Enterocolitis
Spondyloarthritis
Intervention(s)
Drug: Adalimumab
Primary Outcome(s)
Change in Intestinal Inflammation Measured by Faecal Calprotectin [Time Frame: Baseline to 52 weeks]
Change Lewis Score Index [Time Frame: 20 weeks]
Secondary Outcome(s)
Assessment Group in Ankylosing Spondylitis (ASAS) Core Set for Clinical Practice [Time Frame: one year]
Spondyloarthritis Consortium of Canada Score [Time Frame: one year]
Secondary ID(s)
4682724
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Abbott
Central Denmark Region
Given Imaging Ltd.
Ethics review
Results
Results available: Yes
Date Posted: 17/11/2014
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01174186
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