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    Summary
    EudraCT Number:2009-018085-35
    Sponsor's Protocol Code Number:4682724
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-05-05
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2009-018085-35
    A.3Full title of the trial
    Intestinal Inflammation in Ankylosing Spondylitis assessed by Fecal Calprotectin, Capsular Endoscopy and Colonoscopy and the effects of Adalimumab on mucosal healing
    INTestinal inflammation ved Ankyloserende Spondylitis vurderet ved fæces calprotectin, kapselendoskopi og koloskopi og effekt af Adalimumab på mucosal Heling (INTASAH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intestinal inflammation in ankylosing spondylitis assessed by stoll samples and endoscopy and the effects of adalimumab on inflammation
    Betændelsessygdom i mave-tarm kanalen hos mb. Bechterew patienter bedømt ved afføringprøver og tarmundersøgelser og effekten af adalimumab på opheling af sår.
    A.3.2Name or abbreviated title of the trial where available
    INTASAH
    A.4.1Sponsor's protocol code number4682724
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01174186
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRegionalhospital Silkeborg
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAbbott Laboratories
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportEuropean Capusule Endoscopy Group
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportGigtforeningen
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportRegion Midtjylland
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportRegionshospitalet Silkeborg
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegionshospitalet Silkeborg
    B.5.2Functional name of contact pointStudieledelse
    B.5.3 Address:
    B.5.3.1Street AddressFalvej 1-3
    B.5.3.2Town/ citySilkeborg
    B.5.3.3Post code8600
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4587222360
    B.5.6E-mailhenngler@rm.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Humira
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories LTD.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ankylosing spondylitis
    Inflammatory bowel disease
    Morbus Bechterew
    Inflammatorisk tarmsygdom
    E.1.1.1Medical condition in easily understood language
    Arthritis of the vertebral column
    Rygsøjlegigt
    Betændelsessygdom af tarmen
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10061371
    E.1.2Term Spondylitis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10041672
    E.1.2Term Spondylitis ankylosing
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10048398
    E.1.2Term Spondylitis ankylosing aggravated
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10041671
    E.1.2Term Spondylitis ankylopoietica
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10041673
    E.1.2Term Spondylitis NOS
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To establish the proportion of otherwise intestinally low-symptomatic patients with intestinal ulcers in patients diagnosed with active spondyloarthritis and to illustrate the healing rate following treatment with the TNF-alpha inhibitor adalimumab
    E.2.2Secondary objectives of the trial
    The proportion of patients (%) with mucosal healing of ileal and colon lesions following treatment with adalimumab. • The change in disease activity assessed using ASAS core set for daily practice (25) and BASDAI, BASMI as well as BASFI before and after treatment with adalimumab. • The change in MRI scanning score before and after treatment with adalimumab.
    The correlation between change in Lewis score and change in faecal calprotectin.
    The correlation between change in disease activity in AS and change in Lewis score.
    The correlation between change in AS disease activity assessed by cellular and soluble inflammation markers and change in intestinal inflammation.
    The correlation between change in AS activity assessed using MRI of sacroiliac joint and the whole spine and change in intestinal inflammation.
    The correlation between change in AS activity assessed using MRI of sacroiliac joint and the whole spine and change in cellular and soluble inflammation markers.
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary end point(s)
    1: Mucosal healing after 20 weeks of treatment with adalimumab assessed using Lewis scoring following capsular endoscopy. (Null hypothesis: Treatment for 20 weeks with adalimumab results in no variation in patients with Lewis scoring under 135 following.)
    2: Description whether intestinal ulcers occur in the small bowel in patients with spondyloarthritis assessed by measurement of faecal calprotectin during 52 weeks of treatment (Null hypothesis: No intestinal changes occur in patients with spondyloarthritis)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1: 20 weeks
    2: 52 weeks
    E.5.2Secondary end point(s)
    • The proportion of patients (%) with mucosal healing of ileal and colon lesions following treatment with adalimumab.
    • The change in disease activity assessed using ASAS core set for daily practice (25) and BASDAI, BASMI as well as BASFI before and after treatment with adalimumab.
    • The change in MRI scanning score before and after treatment with adalimumab.
    • The correlation between change in Lewis score and change in faecal calprotectin.
    • The correlation between change in disease activity in AS and change in Lewis score.
    • The correlation between change in AS disease activity assessed by cellular and soluble inflammation markers and change in intestinal inflammation.
    • The correlation between change in AS activity assessed using MRI of sacroiliac joint and the whole spine and change in intestinal inflammation.
    • The correlation between change in AS activity assessed using MRI of sacroiliac joint and the whole spine and change in cellular and soluble inflammation markers.
    E.5.2.1Timepoint(s) of evaluation of this end point
    20 and 52 weeks of treatment
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The study ends at the last visit of the last subject undergoing the trial.
    Studiet slutter når den sidste patient har været til sidste besøg
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After the 52 weeks of follow-up the patient will return to the respective outpatient clinics where they will be treated according to standard guidelines.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-03-11
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