Intestinal Inflammation in Ankylosing Spondylitis and the Effects of Adalimumab on Mucosal Healing (INTASAH)

This study is currently recruiting participants.
Verified July 2012 by Regionshospitalet Silkeborg
Sponsor:
Collaborators:
Abbott
European Capsule Endoscopy Group
The Central Denmark Region
Information provided by (Responsible Party):
Rene Oestgaard, Regionshospitalet Silkeborg
ClinicalTrials.gov Identifier:
NCT01174186
First received: July 16, 2010
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Spondyloarthritis
Intestinal Inflammation
Drug: Adalimumab
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Intestinal Inflammation in Ankylosing Spondylitis Assessed by Fecal Calprotectin, Capsular Endoscopy and Colonoscopy and the Effects of Adalimumab on Mucosal Healing

Resource links provided by NLM:


Further study details as provided by Regionshospitalet Silkeborg:

Primary Outcome Measures:
  • Intestinal inflammation measured by Lewis Score [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Lewis' score descibes the amount of inflammation seen optically by capsular endoscopy

  • Intestinal inflammation measured by faecal calprotectin [ Time Frame: one year ] [ Designated as safety issue: No ]
    describes the amount of neutrophilic inflammation in the intestine, but not the site of inflammation


Secondary Outcome Measures:
  • Spondyloarthritis Consortium of Canada score [ Time Frame: one year ] [ Designated as safety issue: No ]
    Inflammation on MRI

  • Assessment Group in Ankylosing Spondylitis (ASAS) core set for clinical practice [ Time Frame: one year ] [ Designated as safety issue: No ]
    clinical measurements of inflammation in spondyloarthritis patients


Estimated Enrollment: 30
Study Start Date: October 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Spondyloarthritis
Spondylitis patients with active inflammation
Drug: Adalimumab
Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given
Other Name: Humira

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. opticus 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174186

Contacts
Contact: René D Oestgaard, M.D. +4561678127 ostgard@immunology.au.dk

Locations
Denmark
Department of Rheumatology U, Aarhus Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Bent Deleuran, MD       b.deleuran@dadlnet.dk   
Contact: Ib T Hansen, MD       Ib.Toender.Hansen@Viborg.RM.dk   
Sub-Investigator: Bent Deleuran, MD         
Principal Investigator: Ib Tn Hansen, MD         
Regional Hospital of Horsens, Department of Medicine Recruiting
Horsens, Denmark, 8700
Contact: Barbara Unger, MD       Barbara.Unger@horsens.rm.dk   
Principal Investigator: Barbara Unger, MD         
Regional Hospital of Randers, Department of Medicine Recruiting
Randers, Denmark
Contact: Peter M Petersen, MD       petepete@rm.dk   
Principal Investigator: Peter M Petersen, MD         
Regional Hospital of Silkeborg Recruiting
Silkeborg, Denmark, 8600
Contact: René D Oestgaard, M.D.    +45 61 67 81 27    ostgard@immunology.au.dk   
Principal Investigator: René D Oestgaard, MD         
Principal Investigator: Henning Glerup, MD         
Sponsors and Collaborators
Regionshospitalet Silkeborg
Abbott
European Capsule Endoscopy Group
The Central Denmark Region
Investigators
Study Chair: Henning Glerup, M.D. Regional Hospital Silkeborg, medical department
Study Director: René D Oestgaard, M.D. Regional Hospital Silkeborg, medical department
Principal Investigator: Bent Deleuran, M.D. Department of Medical Microbiology and Immunology Aarhus University
  More Information

No publications provided

Responsible Party: Rene Oestgaard, René Østgård, MD, Regional Hospital Denmark, medical department, Regionshospitalet Silkeborg
ClinicalTrials.gov Identifier: NCT01174186     History of Changes
Other Study ID Numbers: 4682724
Study First Received: July 16, 2010
Last Updated: July 6, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Inflammation
Spondylitis
Spondylitis, Ankylosing
Spondylarthritis
Pathologic Processes
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Ankylosis
Joint Diseases
Arthritis
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 14, 2014