Intestinal inflammation in ankylosing spondylitis assessed by stoll samples and endoscopy and the effects of adalimumab on inflammatio

Phase 1

• Conditions: Ankylosing spondylitis Inflammatory bowel disease; MedDRA version: 14.0Level: PTClassification code 10061371Term: SpondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 14.0Level: LLTClassification code 10041672Term: Spondylitis ankylosingSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 14.0Level: LLTClassification code 10048398Term: Spondylitis ankylosing aggravatedSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 14.0Level: LLTClassification code 10041671Term: Spondylitis ankylopoieticaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 14.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 14.0Level: LLTClassification code 10041673Term: Spondylitis NOSSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2009-018085-35-DK
• Lead Sponsor: Regionalhospital Silkeborg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-05
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients (>18 years and =45 years) with axial SpA according to the ASAS criteria
Active SpA assessed by physician.
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Diagnosed inflammatory bowel disease or high risk of intestinal stricture (previous abdominal stricture, radiation of abdomen, major abdominal surgery).
NSAID ingestion less than 4 weeks before inclusion.
Persons with latent 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), active chronic inflammatory bowel disease, 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 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified