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    The EU Clinical Trials Register currently displays   40977   clinical trials with a EudraCT protocol, of which   6698   are clinical trials conducted with subjects less than 18 years old.
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    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) .
     
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    Summary
    EudraCT Number:2012-004089-16
    Sponsor's Protocol Code Number:1541-128
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-03-06
    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 ConcernedAustria - BASG
    A.2EudraCT number2012-004089-16
    A.3Full title of the trial
    The effect of the interleukin-1 receptor antagonist Anakinra in patients with osteoarthritis of the hand:
    The AHOA (Anakinra in hand osteoarthritis) pilot study
    Interleukin-1 Receptor-Blockade mit Anakinra zur
    Therapie der Fingerpolyarthrose
    Eine randomisierte, doppelblinde, Placebo-kontrollierte Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Blocking the inflammation-factor IL-1 as treatment for degenerative joint disease of the hands
    Blockade des Entzündungsbotenstoffes IL-1 als Therapie bei Knorpelverschleißerkrankung der Fingergelenke
    A.3.2Name or abbreviated title of the trial where available
    The AHOA (Anakinra in hand osteoarthritis) pilot study
    Anakinra bei Fingerpolyarthrose
    A.4.1Sponsor's protocol code number1541-128
    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 SponsorUniversitätsklinik für Innere Medizin III, Klinische Abteilung für Rheumatologie, Medizinische Universität Wien
    B.1.3.4CountryAustria
    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 supportSwedish Orphan Biovitrum GmbH
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinik für Innere Medizin III, Klinische Abteilung für Rheumatologie, Medizinische Universität Wien
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressWaehringer Guertel 18-20
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number+431404004301
    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 Kineret
    D.2.1.1.2Name of the Marketing Authorisation holderSwedish Orphan Biovitrum International AB
    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.3.1Product nameAnakinra
    D.3.2Product code not applicable
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNANAKINRA
    D.3.9.1CAS number 143090-92-0
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive namena
    D.3.9.4EV Substance CodeSUB05500MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) No
    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
    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 placeboIntraarticular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    osteoarthritis of the hand
    Fingerpolyarthrose
    E.1.1.1Medical condition in easily understood language
    "degenerative" joint disease of finger joints
    Knorpelverschleisserkrankung der Fingergelenke
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Clinical trials have now generated optimism for anti-IL-1ß therapy as a new strategy in OA treatment. Nevertheless, there is an absolute lack in scientific evidence for the efficacy of IL-1beta inhibition in symptomatic non-erosive hand OA, thus, we aim to investigate the efficacy of a treatment with Anakinra 100 mg i.a. every four weeks during 24 weeks versus placebo as a therapeutic intervention in non-erosive symptomatic IPJ OA.
    Ziel der Studie ist es, die Wirkung des Medikaments „Anakinra“ bei Patienten mit schmerzhafter (symptomatischer) Fingerpolyarthrose zu untersuchen. Die Substanz führt zur Blockade des Entzündungsbotenstoffes IL-1. Die Inaktivierung von IL-1 führt zur Schmerzlinderung und in weiterer Folge zur Verbesserung der Gelenkfunktion. Eine gelenkschützende Wirkung wäre zudem denkbar. Es soll nun an insgesamt 30 Patienten untersucht werden, ob eine Verbesserung der klinischen Symptome bei Patienten Fingerpolyarthrose erzielt werden kann.
    E.2.2Secondary objectives of the trial
    Not applicable
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject will be eligible for study participation if he/she meets the following criteria:
    • Males and females > 18 years of age. All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study.
    • Persistent or transient pain/aching at more than 3 days a week in at least one DIP and/or PIP joint with or without bony swelling
    • Hand X-ray showing alterations typical for OA
    • If NSAIDs are used to treat finger joint pain dosage must be stable for at least 4 weeks
    • Able and willing to give written informed consent and to comply with the requirements of the study protocol.
    In diese Studie können Patientinnen und Patienten eingeschlossen werden, welche an schmerzhafter (symptomatischer) Fingerpolyarthrose leiden
    E.4Principal exclusion criteria
    A subject will be excluded from the study if he/she meets any of the following criteria:
    • Prior treatment with any investigational agent within 30 days, or five half lives of the product, whichever is longer.
    • Patients suffering from chronic inflammatory rheumatic disease (e.g. rheumatoid arthritis or positive rheumatoid factor or positive anti-CCP antibodies, seronegative spondylarthropathy, haemochromatosis, gout, chondrocalcinosis or other auto-immune diseases
    • Stable dosage for at least 3 months with chondroitin sulfate, glucosamine, biphosphonate, tetracyclines and estrogens is allowed.
    • Prior use of any immunomodulating drug with possible effects on pro-inflammatory cytokine metabolism within 90 days a.o. corticosteroids, methotrexate, sulfasalazine, leflunomide, d-penicillamin, anti-malarials, cytotoxic drugs, TNF blocking agents
    • If the patient is of child-bearing age, she must use effective means of contraception during the study.
    • Use of anticoagulants (cumarins or low-molecular-weight-heparins)
    • Subjects with hand OA showing or having suffered from transient inflammatory attacks of the IPJs characteristic for what has been termed ‘inflammatory’ or ‘erosive’ hand OA.
    • Patient who has a known blood coagulation disorder
    • History of cancer or lymphoproliferative disease
    • Comorbidities: uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (NYHA III, IV), recent stroke (within three months), uncontrolled hypertension (defined as screening systolic blood pressure > 160 mmHg or screening diastolic blood pressure > 100 mmHg), severe pulmonary disease requiring hospitalization or supplemental oxygen
    • Impaired renal function (CL Cr <30 ml/minute)
    • Persistent or recurrent infections or severe infections requiring hospitalization or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment.
    • Female subjects who are breast-feeding.
    • History of clinically significant drug or alcohol abuse in the last year.
    • Medical history of systemic lupus erythematosus or other connective tissue disease, RA, reactive arthritis, psoriasis
    • Reasonable expectation that the subject will not be able to satisfactorily complete the study. History of or current psychiatric illness, alcohol or drug abuse that would interfere with the subject’s ability to comply with protocol requirements or give informed consent.
    Patienten mit chronisch entzündlichen Erkrankungen (beispielsweise chronische Polyarthritis, Psoriasisarthritis, aber auch erosive oder aktivierte Fingerpolyarthrose) werden nicht in die Studie eingeschlossen. Die Einnahme entzündungsmodulierender Medikamente (wie Kortison, Methotrexat, usw.) schließt eine Aufnahme in diese Studie ebenfalls aus
    E.5 End points
    E.5.1Primary end point(s)
    improvement of joint pain
    Verbesserung des Gelenkschmerzes
    E.5.1.1Timepoint(s) of evaluation of this end point
    every visit (Week-2,0,2,4,8,12,16,20,24,52)
    jede Visite (Woche-2,0,2,4,8,12,16,20,24,52)
    E.5.2Secondary end point(s)
    structure modifying effects as determined by MRI scan
    improvement of specific and generic physical function and joint stiffness
    improvement of patient global assessment
    Strukturmodifikation nachgewiesen durch MRT
    Verbesserung der Gelenkfunktion
    Verbesserung des patient global assessment
    E.5.2.1Timepoint(s) of evaluation of this end point
    structure modifying effects as determined by MRI scan: week-2 and week 52
    improvement of specific and generic physical function and joint stiffness: Week-2,0,2,4,8,12,16,20,24,52
    improvement of patient global assessment: Week-2,0,2,4,8,12,16,20,24,52
    Strukturmodifikation nachgewiesen durch MRT: Woche -2 und 52
    Verbesserung der Gelenkfunktion: Woche-2,0,2,4,8,12,16,20,24,52
    Verbesserung des patient global assessment: Woche-2,0,2,4,8,12,16,20,24,52
    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 Yes
    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 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 No
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state50
    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)
    None
    Keine
    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 Decision2013-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-04
    P. End of Trial
    P.End of Trial StatusOngoing
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