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    Summary
    EudraCT Number:2018-004284-30
    Sponsor's Protocol Code Number:CAN_1_2018
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-29
    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 ConcernedGermany - PEI
    A.2EudraCT number2018-004284-30
    A.3Full title of the trial
    Effectiveness of Canakinumab for first line steroid free treatment in systemic onset juvenile idiopathic arthritis / juvenile Still’s disease
    Effektivität von Canakinumab zur steroidfreien Erstbehandlung bei systemischer juveniler idiopathischer Arthritis/ M.Still.- Canakinumab first
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Repsonse to Treatment with Canakinumab without steroids early after diagnosis of systemic onset juvenile idiopathic arthritis / juvenile Still’s disease
    Ansprechen auf eine frühzeitige Behandlung mit Canakinumab ohne Steroide bei systemischer idiopathischer Arthritis (M.Still)
    A.3.2Name or abbreviated title of the trial where available
    CANAKINUMAB FIRST
    A.4.1Sponsor's protocol code numberCAN_1_2018
    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 SponsorAsklepios Klink Sankt Augustin
    B.1.3.4CountryGermany
    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 supportNovartis Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAsklepios Klinik Sankt Augustin
    B.5.2Functional name of contact pointAriane Klein
    B.5.3 Address:
    B.5.3.1Street AddressArnold-Janssen-Straße 29
    B.5.3.2Town/ citySankt Augustin
    B.5.3.3Post code53757
    B.5.3.4CountryGermany
    B.5.4Telephone number004902241249496
    B.5.5Fax number004902241249218
    B.5.6E-mailar.klein@asklepios.com
    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 Ilaris
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 nameIlaris
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    systemic juvenile idiopathic arthritis
    systemische juvenile idiopathische Arthritis, Morbus Still
    E.1.1.1Medical condition in easily understood language
    systemic juvenile idiopathic arthritis
    systemische juvenile idiopathische Arthritis, Morbus Still
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10079454
    E.1.2Term Systemic juvenile idiopathic arthritis
    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
    To demonstrate high rate of response to monotherapy with Canakinumab in newly diagnosed sJIA/Still’s disease patients not treated with corticosteroids.
    Nachweis einer hohen Ansprechrate auf die Monotherapie mit Canakinumab bei neu diagnostizierten sJIA / Still-Patienten, die nicht länger als 7 Tage mit Kortikosteroiden behandelt wurden.
    E.2.2Secondary objectives of the trial
    Steroid free remission at month 6 defined as no fever>38.0°C, no arthritis defined as joint swelling or pain on motion and limited range of motion, normal CRP, no organ involvement attributed to sJIA/Still’s disease.
    To demonstrate improvement by validated outcome criteria (JADAS, ACR-Response, ACR-Remission-criteria.
    To demonstrate normal growth.
    To demonstrate safety of Canakinumab injection in sJIA / juvenile Still’s disease patients not treated with corticosteroids.
    To evaluate number of patients who have reached a steroid dose of 0 at month 6.
    To explore the time to inactive disease.
    To validate biomarkers for early diagnosis of Still’s disease
    To establish new panel diagnostics
    To monitor immune activation during follow-up.
    Steroidfreie Remission im 6. Monat definiert als kein Fieber>38,0°C, keine Arthritis definiert als Gelenkschwellungen oder Schmerzen bei Bewegung und eingeschränkter Bewegungsumfang, normales CRP, keine Organbeteiligung zurückzuführen auf sJIA/Still's Krankheit.
    Nachweis der Verbesserung durch validierte Ergebniskriterien (JADAS, ACR-Response, ACR-Remissionskriterien).
    Normales Wachstum zu zeigen.
    Nachweis der Sicherheit der Canakinumab-Injektion bei Patienten mit sJIA / juveniler Still-Krankheit, die nicht mit Kortikosteroiden behandelt wurden.
    Zur Beurteilung der Anzahl der Patienten, die eine Steroiddosis von 0 im Monat 6 erreicht haben.
    Um die Zeit bis zur inaktiven Krankheit zu erforschen.
    Validierung von Biomarkern für die Früherkennung der Morbus Still.
    Um eine neue Paneldiagnose zu etablieren
    Zur Überwachung der Immunaktivierung während der Nachsorge.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Parents / legal guardian and patient are willing to participate in the study and signed voluntarily the Informed Consent form.
     I 2 Patient and parents / legal guardian agree to comply with study requirements and are able to be at the clinic for all required study visits.

     I 3 Patient is at least 2 years old and has not reached his 18th birthday.

     I 4 Patient is currently not treated with a disease-modifying antirheumatic drug (DMARD). Patient has not been treated with synthetic DMARDs (such as Methotrexate, Leflunomide, Azathioprine, Hydroxychloroquine, Chloroquine …) or biologic DMARDs (such as Anakinra, Canakinumab, Tocilizumab, Etanercept, Adalimumab, Golimumab …) before baseline.
     I 5 Stable dosage of NSAIDs
     I 6 Patient is currently not treated with corticosteroids. Patient has previously not been treated with corticosteroids for more than 7 days after diagnosis.

     I 7 IN FEMALE PATIENT IN WHOM MENARCHE HAS OCCURRED
    • Negative serum pregnancy test prior to administration of study medication.
    • Willingness to use an adequate method of contraception
    Adequate contraception can include abstinence if the investigator deems appropriate.
     I 8 Diagnosis of active systemic onset JIA as determined by International League of Associations for Rheumatology (ILAR) criteria (Petty RE, Southwood TR, Manners P, Baum J, Glass DN, Goldenberg J, et al. J Rheumatol. 2004;31:390–392) or the Yamaguchi’s criteria for Still’disease ( Yamaguchi M. et al., J Rheumatol. 19:424-30, 1992) with confirmed diagnosis of SJIA as per ILAR definition:
    Arthritis in one or more joints with or preceded by fever of at least 2 weeks duration that is documented to be daily/ quotidian for at least 3 days and accompanied by one or more of the following:
    · Evanescent nonfixed erythematous rash,
    · Generalized lymph node enlargement,
    · Hepatomegaly and/ or splenomegaly,
    · Serositis
    or
    confirmed diagnosis of Still’s disease as per Yamaguchi’s criteria:
    Five or more criteria, of whom two or more must be major
    Major criteria
    ▪ Fever >39 °C, lasting 1 week or longer
    ▪ Arthralgia or arthritis, lasting 2 weeks or longer
    ▪ Typical rash
    ▪ Leukocytosis >10,000/mm3 with >80% polymorphonuclear cells
    Minor criteria
    ▪ Sore throat
    ▪ Recent development of significant lymphadenopathy
    ▪ Hepatomegaly or splenomegaly
    ▪ Abnormal liver function tests
    ▪ Negative tests for antinuclear antibody (IF) and rheumatoid factor (IgM)
    Exclusion criteria
    ▪ Infections
    ▪ Malignancies (mainly malignant lymphoma)
    ▪ Other rheumatic disease (mainly systemic vasculitides)
    The activity of the disease is judged with
    (I) active arthritis joints with either swelling not due to deformity or if no
    swelling is present with limiting of motion and pain or pain on movement,
    (II) a least a score of 3 of 10 for global assessment of the severity of disease by the physician
    (III) a least a score of 3 of 10 for global assessment of overall well-being by the
    patient or parent
    (IV) active systemic signs of the disease for at least 3 days before baseline with either fever of more than 38.5°C, and/or pericarditis and/or rash.

     I 9 Patient have to meet all criteria for eligibility for treatment with Canakinumab according to SPC and local guidelines, with exception of the requirement of a minimum of five affected joints.
     I 10 Either the subject or an available adult must be capable (according to the investigator´s judgment of reconstituting and administering injections of SC Canakinumab.
     I 11 Patient must be evaluated for active or latent TB infection according to the instructions of the protocol. If applicable: Guidelines regarding the treatment of latent TB must be followed prior to the administration of study medication.
    E.4Principal exclusion criteria
    E 1 Chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 30 days prior to study screening
    E 2 Any preceding diagnosis of malignancy.
    E 3 Pregnant or breast feeding female.
    E 4 Female not willing to use appropriate contraception or sexual abstinence.
    E 5 Active gastrointestinal disease (e.g., inflammatory bowel disease)
    E 6 Significant blood clotting defect
    E 7 Patient has a history of any chronic disease other than JIA, especially chronic renal disease, liver disease, hematological, gastrointestinal, pulmonary, cardiological or neurological disease, which in the opinion of the investigator may influence the efficacy or safety of the study medication or which in the opinion of the investigator leads to an unacceptable risk for the patient if he participates in the Study.
    E 8 Patient had a significant illness during a period of 4 weeks prior to the first administration of study medication other than JIA-related.
    E 9 Previous use of systemic corticosteroids for more than 7 days (>0.2 mg/kg bw)
    E10 Previous use of immunosuppressants (such as methotrexate, cyclosporine)
    E11 Previous use of biologic agents (such as Anakinra, Canakinumab, Tocilizumab)
    E12 Active macrophage activation syndrome with biologic features of MAS [such as hemorrhages, central nervous system dysfunction, plasma fibrinogen level < 2.5 g/L, cytopenia, hypertriglyceridemia, decreased platelet count, hyperferritinemia at screening or a history of recurrent pericarditis, myocarditis, serositis.
    E 13 AST (SGOT), ALT (SGPT), or BUN levels more than two times the upper level of normal, creatinine levels more than 1.5 mg/dl, or any other laboratory abnormality considered to be clinically significant within 28 days prior to baseline
    E 14 Received any investigational medication within 30 days prior to the first dose of study medication or scheduled to receive an investigational drug (other than the study medications) during the course of the study
    E 15 Patient has previously been admitted to this study.
    E 16 Patients is known to be HIV-infected
    E 17 Known past or current hepatitis infection
    E 18 Patient has a history of an expanding CNS neoplasm, active CNS infection, demyelinating disease, degenerative neurological disease or any progressive CNS disease.
    E 19 Patient has a poorly controlled diabetes.
    E 20 Received a live virus vaccine within 1 month prior to baseline
    E 21 Any concurrent medical condition which would, in the investigator's opinion, compromise the patient's ability to tolerate the study drug or would make the patient unable to comply with the protocol.
    E 22 Patient has a history of or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
    E 23 Patient has a recent history of alcohol or drug abuse within the past 6 months that would interfere with ability to comply with protocol requirements.
    E 24 Any contraindication listed in the German 'Fachinformation' of the drug Ilaris ®
    E.5 End points
    E.5.1Primary end point(s)
    High Response rates with a high percentage of children reaching steroid free inactive disease at month 3 and medication free Remission at month 12
    Hohe Ansprechraten mit einem hohen Prozentsatz von Kindern, die steroidfreie inaktive Krankheiten im dritten Monat und medikamentenfreie Remissionen im zweiten Monat erreichen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month3, Month 12
    Monat 3, Monat 12
    E.5.2Secondary end point(s)
    High percentage of patients with steroid free remission at month 6 defined as no fever>38.0°C, no arthritis defined as joint swelling or pain on motion and limited range of motion, normal CRP, no organ involvement attributed to sJIA / juvenile Still’s disease.
    High percentage of improvement by validated outcome criteria (JADAS, ACR-Response, ACR-Remission-criteria throughout the study).
    Normal growth rates (relation of length SDS baseline to length SDS at month 6 and month 12)
    acceptable safety of canakinumab injection in sJIA/still’s disease patients not treated with corticosteroids.
    High number of patients who have reached a steroid dose of 0 at month 6 and month 12.
    • To validate biomarkers for early diagnosis of sJIA / juvenile Still’s disease.
    • To establish new panel diagnostics to monitor immune activation during follow-up
    Hoher Prozentsatz der Patienten mit steroidfreier Remission an Monat 6 Definition: kein Fieber>38,0°C, keine Arthritis definiert als Gelenkschwellung oder Schmerzen bei Bewegung und eingeschränkter Bewegungsumfang, normales CRP, keine Organbeteiligung zurückzuführen auf sJIA / M.Still.
    Hoher Prozentsatz an Verbesserung der validierte Ergebniskriterien (JADAS, ACR-Response, ACR-Remissionskriterien während der gesamten Studie).
    Normale Wachstumsraten (Verhältnis von Länge SDS-Basislinie zu Länge SDS an Monat 6 und Monat 12)
    Akzeptable Sicherheit der Canakinumab-Injektion bei Patienten mit sJIA/Still-Krankheit, die nicht mit Kortikosteroiden behandelt werden.
    Hohe Anzahl von Patienten, die an Monat 6 und 12 eine Steroiddosis von 0 erreicht haben.
    Validierung von Biomarkern für die Früherkennung von sJIA / M.Still.
    Erstellung einer neuen Panel-Diagnostik zur Überwachung der Immunaktivierung während der Nachbeobachtung
    E.5.2.1Timepoint(s) of evaluation of this end point
    Months 3,6,12
    Monate 3,6,12
    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 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 No
    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.8.2.4Number of treatment arms in the trial1
    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 concerned5
    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
    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 Yes
    F.1.1Number of subjects for this age range: 20
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    underage childern
    Kinder
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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)
    Clinical Routine, IMP is approved for the indication
    Klinsiche Routine, das Prüfpräparat ist für diese Indikation zugelassen
    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 Decision2019-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-13
    P. End of Trial
    P.End of Trial StatusOngoing
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