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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   41228   clinical trials with a EudraCT protocol, of which   6756   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Summary
    EudraCT Number:2006-001816-56
    Sponsor's Protocol Code Number:HUM 05-064
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2006-04-28
    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 number2006-001816-56
    A.3Full title of the trial
    Can PET scan be used to assess disease activity in patients with sarcoidosis during treatment with adalimumab (Humira)?
    A.3.2Name or abbreviated title of the trial where available
    KOMPLET
    A.4.1Sponsor's protocol code numberHUM 05-064
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRigshospitalet
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 AuthorisationDenmark
    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 Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    sarcoidosis
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate sarcoidosis activity by FDG-PET scan and chest x-ray in treatment refractory patients, in whom treatment with adalimumab (Humira®) is initiated.
    E.2.2Secondary objectives of the trial
    Changes in lung function including FEV1, FVC, VCexp, VCinsp, TLC and DLCO from baseline to weeks 4, 8, 12, 16, 20, and 24.
    Changes in Short Form-36 health status survey (SF-36) from baseline to weeks 12 and 24.
    Changes in biochemistry markers for disease activity including B-haemoglobin, B-platelets, B-leukocytes, B-leukocyte count, B-CD4 lymphocytes, B-CD8 lymphocytes, P-IgG, P-IgA, P-IgM, P-IgE, S-angiotensin converting enzyme (SACE), S-soluble-interleukin-2-receptor (S-sIL-2R), S-YKL-40, P-creatinine, P-aspartate aminotransferase, P-alkaline phosphatase, P-bilirubin, INR, P-ionized calcium, P-total calcium, P-albumin from baseline to weeks 4, 8, 12, 16, 20, and 24.
    To demonstrate the safety of adalimumab treatment of patients with sarcoidosis by registering the number and severity of adverse events reported during this trial.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    A person may participate in this trial if he/she fulfils the following criteria:
    - Patients (>= 18 years) with verified biopsy of sarcoidosis according to The Joint Statement of the American Thoracic Society (ATS), the European Respiratory Society (ERS) and the World Association of Sarcoidosis (WASOG) criteria.
    - Clinically and/or biochemical disease activity in one or more organ systems defined as decreased lung function (FEV1 <70% of expected value and/or DLCO <70% of expected value; hypercalcaemia; impact on liver (elevated alkaline phosphatase and bilirubin and/or aspartate aminotranferase.
    - Previous treatment with prednisolon tablets 5-10 mg/week for at least 6 months with inadequate clinical and/or biochemical response as judged by Investigator.
    - Pathological increased FDG uptake on PET imaging corresponding to at least one known focus at first FDG PET scan.
    - Negative pregnancy test (serum HCG) for women of childbearing potential prior to trial start. (Non-fertile women defined as postmenopausal for at least 1 year or surgical sterilisation (bilateral tubal ligation, bilateral ooforectomy or hystorectomy)). Fertile women included in the trial should use contraceptives during the entire trial period (i.e. one of the following methods: Oral contraceptives, intrauterine device (IUD), depot injection of progesterone, subdermal implantation, contraceptive vaginal ring, transdermal depot plaster). Contraceptives should also be used for a period of 150 days after any discontinuation of trial medicine.
    - Ability and willingness to inject the s.c. injections him/herself or to have a person available for giving the injections.
    - Ability and willingness to give written informed consent and meet the requirements in the trial protocol.
    E.4Principal exclusion criteria
    A person may not participate in this trial, if he/she fulfils one or more of the following criteria:
    - Positive serology for Hepatitis B or C indicating active infection.
    - Medical history with positive HIV status.
    - Medical history with tuberculosis, histoplasmosis or listeriosis.
    - Persons with latent TB (positive Mantoux skin-test, positive Quantiferon-Gold test, positive inoculation of mycobacterium in tissue samples and/or chest x-ray indicating TB) or other risk factors for activating latent TB.
    - Active or recurrent infections or severe infections requiring hospitalization or treatment with i.v. antibiotics within the last 30 days or oral antibiotics within the last 14 days prior to inclusion.
    - Previous cancer or lymph proliferative disease except from completely well treated squamous cell carcinoma, basal cell carcinoma or cervix dysplasia.
    - Diabetes, unstable ischemic heart disease, heart insufficiency (NYHA III-IV), active chronic inflammatory intestinal disease, recent cerebral apoplexia (within 3 months), chronic leg ulcus or any other condition (e.g. catheter à demeure) imposing an increased risk to the subject, if he/she participates in the protocol, as judged by Investigator.
    - Pregnancy or breast-feeding.
    - Clinically significant drug or alcohol abuse during the last year.
    - Previous diagnosis or signs of demyelinized disease in the CNS system (e.g. optic neuritis, visual disorder, difficulty in walking/ataxia, facial paresis, apraxia).
    - No pathological increased FDG PET imaging at first FDG PET scan.
    E.5 End points
    E.5.1Primary end point(s)
    FDG-PET: FDG-PET positive foci will be determined both qualitatively and semi-quantitatively. Qualitatively: Pathological foci will be described from visual determination indicating anatomic localisation by means of fusion of FDG-PET with low dose CT (organ/lymph node region). Metabolism of any of the most substantial focus in the lungs, mediastinum and extra pulmonary will be determined quantitatively by calculation of Standardized Uptake Value (SUV) which states the imaging in focus compared to the mean whole body imaging. Finally, the patient’s two scans (blinded) will be compared (are they similar or which scan shows the most pronounced activity) with the purpose of assessing whether the changes have worsened, improved or are unchanged. The percentage of change between the first and second examination will be determined by the SUV values.
    Lung function: The lung function parameters will be stated in absolute values and in % of expected value compared to the European normal material. Each parameter value will be compared over the time period of the examination and change from first to second examination will be determined.
    A correlation analysis of change in FDG PET and lung function will be performed: % change in FDG SUV for most substantial focus will be correlated with change in DLCO and VC insp.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Use of FDG-PET scan
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    May 2007
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-04-28. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    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 Decision2006-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-03
    P. End of Trial
    P.End of Trial StatusOngoing
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