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    Summary
    EudraCT Number:2014-005722-35
    Sponsor's Protocol Code Number:H--6-2014-070
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-02-09
    Trial 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 number2014-005722-35
    A.3Full title of the trial
    Measures of inflammation in low back pain (LBP) and anti-TNFα for the treatment of deemed discogenic LBP - an explorative study
    Measures of inflammation in low back pain (LBP) and anti-TNFα for the treatment of deemed discogenic LBP - an explorative study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Measures of inflammation in low back pain and anti-TNFα (anti-inflammation treatment) for the treatment of deemed low back pain - an explorative study
    A.4.1Sponsor's protocol code numberH--6-2014-070
    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 SponsorGlostrup University Hospital
    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 supportIMK Almene Fond
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlostrup University Hospital
    B.5.2Functional name of contact pointCenter for Rheumatology and Spine
    B.5.3 Address:
    B.5.3.1Street AddressNdr. Ringvej 57, Entrance 5,1
    B.5.3.2Town/ cityGlostrup
    B.5.3.3Post code 2600
    B.5.3.4CountryDenmark
    B.5.6E-mailtom.bendix@regionh.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 (adalinomap)
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.1Product nameHumira
    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.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number40 to 80
    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 No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Low back pain with and without legg-pain

    In the late periode 1990ies it became clear that various cytokines and other inflammatory elements played a large role for low back pain. One of the known inflammatory substances TNF-α (Tumor Necrosis Factor-α) has been demonstrated in the discs’ nuclear tissue, particular with degeneration.
    E.1.1.1Medical condition in easily understood language
    Low back pain

    In the late periode 1990ies it became clear that inflammation played a large role for low back pain. TNF-α treatment may be usefull.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10024891
    E.1.2Term Low back pain
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10024892
    E.1.2Term Low back pain (without radiation)
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In this observational pilot trial, where we aim at studying the possible feasibility of TNF-α inhibitor treatment against chronic discugen Low back pain.
    E.2.2Secondary objectives of the trial
    In this observational pilot trial, where we aim at studying inflammatory blood markers presence in these LBP cases, and their optional reduction with Humira treatment.
    Further, the presence and location of optional inflammation following what is deemed to be included in long-lasting, discogenic LBP, using Dynamic Enhanced Contrast (DEC-)MRI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients between 18-65 years

    Operation (spondylodesis) is considered

    A current episode of 3-12 months of low back pain without clinical indications of soon recovery. Back pain [>40 / VAS scale 0 (no pain) – 100 (maximum imaginable pain)] dominates over possible leg pain.

    A conventional MRI no older than 4 weeks are speaking for discogenic LBP

    A degenerative disc (> Pfirrmann grade 3), corresponds location wise to the maximum site of pain.

    Modic change type 1 in previous conventional MRI scan

    The level of the deemed discogenic LBP must correspond by a physician’s ‘springing test’ (a.m. McKenzie) over the same lumbar level, as this will speak for a single level affection.
    E.4Principal exclusion criteria
    Women with pregnancy potential have to undergo a pregnancy test prior to injection and scannings. Contraceptives is mandatory up to 3 months after treatment given. Further, planned pregnancy within the first 3 months after treatment cannot participate. Hereby, following the guidelines by Danish Health and Medicines Authority (Sundhedstyrelsen) See 8.2.

    Active or latent tuberculosis

    Hepatitis B and C infection

    Diabetes

    Planning surgery in the spine not related to the discugenic pain.

    Invasive cancer disease

    Spondylartropaty, Rheumatoid arthritis or other inflammatory joint disease

    Severe heart disease or failure

    Prior spine infection

    COPD - Chronic obstructive airway disease

    Surgery in the lumbar spine

    Any previous treatment with Etanercept

    Allergy to Humira

    Allergy to Gadolinium contrast

    Decreased estimated glomerular filtration rate (eGFR <60 ml/min/1.73m2) assessed by blood test

    Widespread pain (clear non-organic symptoms)

    Patients with inability to communicate in Danish or in English

    “Red flag symptoms.”
    E.5 End points
    E.5.1Primary end point(s)
    1 Pain will be evaluated by using the 13 items Pain-Detect questionnaire, which includes measurements of LBP on an ordinal 11-point numerical rating scale (NRS: 0 = no LBP; 10 = worst possible LBP)

    2 The validated 24-item Oswestry Disability Index will measure participant-rated LBP disability

    E.5.1.1Timepoint(s) of evaluation of this end point
    Will be evaluated 3, 6 and 12 months post-baseline
    E.5.2Secondary end point(s)
    1 Dynamic Contrast Enhanced -MRI

    2. Inflammations markers hsCRP, IL-1, TNF-alfa
    E.5.2.1Timepoint(s) of evaluation of this end point
    Will be evaluated 3, 6 and 12 months post-baseline
    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 Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 will stop inclusion when 40 persons have received treatment or placebo. Sponsor may at any time stop the project. The project will be stopped if any circumstances compromise the safety of trial participants or pose a health risk. When suspected, the project will initially be suspended while the relationship explored, and can be determined whether the relationship can be attributed to the intervention and / or the studie’s assessments.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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.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)
    Non
    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 Decision2015-06-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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