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    Summary
    EudraCT Number:2011-004915-22
    Sponsor's Protocol Code Number:A3921145
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2012-06-11
    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 - BfArM
    A.2EudraCT number2011-004915-22
    A.3Full title of the trial
    A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Long-Term, Open-Label, Study for Treatment of JIA
    A.4.1Sponsor's protocol code numberA3921145
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01513902
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/296/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Inc, 235 East 42nd Street, New York, New York 10017
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    B.5.5Fax number0013037391119
    B.5.6E-mailclinicaltrials.govcallcenter@pfizer.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 XELJANZ
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer 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.3.2Product code CP-690,550-10
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTofacitinib
    D.3.9.1CAS number 540737-29-9
    D.3.9.2Current sponsor codeCP-690,550-10
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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.IMP: 2
    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 No
    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.3.2Product code CP-690,550-10
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTofacitinib
    D.3.9.1CAS number 540737-29-9
    D.3.9.2Current sponsor codeCP-690,550-10
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    JUVENILE IDIOPATHIC ARTHRITIS (JIA)
    E.1.1.1Medical condition in easily understood language
    Juvenile Idiopathic Arthritis (formerly known as Juvenile Rheumatoid Arthritis)
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10059176
    E.1.2Term Juvenile idiopathic arthritis
    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
    The primary objective of this study is to determine the long term safety and tolerability of tofacitinib for treatment of the signs and symptoms of JIA.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to evaluate the persistence of efficacy of tofacitinib for treatment of the signs and symptoms of JIA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pediatric subjects with JIA aged from 2 to less than 18 years who met entry criteria for the qualifying/index study and in the opinion of the investigator have sufficient evidence of JIA disease activity to warrant use of tofacitinib as a DMARD. Subjects turning 18 years of age during participation in the qualifying/index study or subsequently will be eligible for participation in this study.
    2. The subject has discontinued disallowed concomitant medications for the required time prior to the first dose of study drug, as defined in Appendix 1, and is taking only those concomitant medications in doses and frequencies allowed by the protocol.
    3. Fertile male subjects and female subjects of childbearing potential who are, in the opinion of the investigator, sexually active and at risk for pregnancy with their partner(s) must be using a highly effective method of contraception as outlined in this protocol throughout the study and for at least 28 days after the last dose of study medication.
    4. Subjects must have previously completed participation in a qualifying study of
    tofacitinib for the treatment of JIA. Subjects who have required earlier
    discontinuation of treatment in a qualifying study for reasons other than tofacitinib related serious adverse events may be eligible.
    5. For subjects receiving methotrexate (MTX) treatment, MTX may be administered either orally or parenterally at doses not to exceed 25 mg/week or 20 mg/m2/week, whichever is lower. Subjects taking methotrexate must be taking folic acid or folinic acid in accordance with local standards.
    6. For subjects receiving an oral glucocorticoid, glucocorticoids may be administered at a maximum dose of 0.20 mg/kg/day or 10 mg/day, prednisone or equivalent, whichever is lower (intramuscular and intravenous corticosteroids are not permitted in the 4 weeks preceding the first dose of study medication and throughout the study).
    For subjects coming from the systemic JIA study A3921165, a higher prednisoneequivalent dose may be continued or started (doses must be 1.0 mg/kg/day up to 30 mg/day oral prednisone [or equivalent]), with the agreement of the Pfizer medical monitor.
    7. For subjects receiving leflunomide treatment, leflunomide may be administered according to the following dosing scheme:
    - 10 mg every other day for subjects weighing less than 20 kg;
    - 10 mg every day for subjects weighing between 20 and 40 kg;
    - 20 mg every day for subjects weighing over 40 kg;
    Or as according to local standards.
    8. For subjects receiving sulfasalazine, chloroquine, or hydroxychloroquine treatment, these medications may be administered according to local standards.
    9. Evidence of a personally signed and dated informed consent document with assent as appropriate indicating that the subject (or a legally acceptable representative/ parent(s)/legal guardian) has been informed of all pertinent aspects of the study.
    10. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
    11. Subjects for whom, in the Investigator’s opinion, treatment with tofacitinib is considered clinically appropriate while also taking into consideration currently
    available therapies and prior response to these therapies.
    Subjects who enroll outside the 14 day window of the EOS Visit of their qualifying/index study must also meet Inclusion Criterion 12 to be eligible for enrollment into the study:
    12. No evidence of active tuberculosis (TB) or inadequately treated tuberculosis (TB) infection (active or latent) as evidenced by all of the following:
    a. A negative QuantiFERON®-TB Gold In-Tube test4 performed within the
    3 months prior to screening. A negative purified protein derivative (PPD) test
    with a result of <5 mm induration can be substituted for the QuantiFERON®-TB
    Gold In-Tube test only if the central laboratory is unable to perform the test or
    cannot determine the results to be positive or negative, and the Pfizer medical
    monitor approves it, on a case-by-case basis.
    b. Chest radiograph without changes suggestive of active tuberculosis(TB) infection
    within 3 months prior to screening is recommended and should be performed
    according to local standards of care or country-specific guidelines (see
    Section 7.2.4).
    c. No history of either untreated or inadequately treated latent or active TB
    infection.
    If a subject has previously received an adequate course of therapy for either latent (9 months of isoniazid in a locale where rates of primary multi-drug resistant TB infection are <5% or an acceptable alternative regimen) or active (acceptable multi-drug regimen) TB infection, neither a PPD test nor a
    QuantiFERON-Gold®TM test need be obtained. A chest radiograph should be
    obtained if not done within the 3 months prior to screening (see Section 7.2.4).
    To be considered eligible for the study, the chest radiograph must be negative for active tuberculosis infection.

    Refer to Protocol
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study: For subjects who enroll outside the 14 day window of the EOS Visit of their qualifying/index study (Exclusion 1-3):
    1) Blood dyscrasas, including: a. Hgb <10 g/dL or Hct <33%. b. WBC <3.0 x 109/L. c. Neutrophil count <1.2 x 109/L. d. Platelet count <100 x 109/L. e. Lymphocyte count of <0.75 x 109/L.
    2) Estimated glomerular filtration rate [GFR] <40 mL/min/1.73 m2 calculated using Bedside Schwartz formula (Appendix 5) at the Screening Visit.
    3) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ³1.5 times the upper limit of normal or any other clinically significant laboratory abnormality. For all subjects:
    4) Persistent oligoarthritis, and undifferentiated JIA.
    5) Current or recent history of uncontrolled clinically significant renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, or neurological disease.
    6) History of any other rheumatic autoimmune disease, other than Sjogren’s syndrome.
    7) History or current symptoms suggestive of any lymphoproliferative disorder, such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease.
    8 ) Infections: a) Chronic infections. b) Any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within the 6 months prior to the first dose of study drug: c) Any treated infections within 2 weeks of baseline visit. (excluding those treated with topicals only) d) A subject known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus.e.History of infected joint prosthesis with prosthesis still in situ.
    9) History of recurrent (more than one episode) herpes zoster or a single episode of disseminated herpes zoster or a single episode of disseminated (both oral and gential lesions simutaneously, or widespread lesions not contaminaed to oral or gential regions alone) herpes simplex.
    10. Subjects taking potent and moderate cytochrome P450 3A4 (CYP3A4) inhibitors (Appendix 6).
    11. Subjects taking potent and moderate CYP3A4 inducers (Appendix 6).
    12. Participation in studies of investigational compounds (excluding qualifying/index study with tofacitinib) within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of study drug. Subjects cannot participate in studies of other investigational compounds at any time during their participation in this study.
    Exposure to investigational biologics should be discussed with the Pfizer Medical
    Monitor.
    13. Any prior treatment with non B cell-specific lymphocyte depleting agents/therapies [eg, almetuzumab (CAMPATH®), alkylating agents (eg, cyclophosphamide or chlorambucil), total lymphoid irradiation, etc]. Subjects who have received rituximab or other selective B lymphocyte depleting agents (including experimental agents) are eligible if they have not received such therapy for at least 1 year prior to study baseline and have normal CD 19/20+ counts by FACS analysis.
    14. Pregnant or nursing females are excluded.
    15. Intramuscular or intravenous corticosteroids in the 4 weeks preceding first dose of study medication (oral corticosteroids permitted as per inclusion criterion).
    16. Subjects who have been vaccinated with live or attenuated vaccines within the 6 weeks prior to the first dose of study medication. All study participants should be up-to-date with respect to standard of care vaccinations (as defined by their country health ministry). (See Life Style Guidelines for further information regarding avoidance of household contacts who may be vaccinated).
    17. Use of prohibited prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
    18. Herbal supplements must be discontinued at least 4 weeks prior to the first dose of study medication.
    19. Subjects with a first degree relative with a hereditary immunodeficiency; IgA
    deficiency not exclusionary.
    20. Subjects with a malignancy or with a history of malignancy with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
    21. Recent (within 28 days prior to first dose of study drug) significant trauma or major surgery.
    22. Unwilling or unable to comply with the Life Style Guidelines described in this
    protocol.
    23. Other severe acute or chronic medical or psychiatric condition or laboratory
    abnormality that may increase the risk associated with study participation or
    investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

    See Protocol Section 4.2 for additional exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    Standard laboratory safety data and adverse event (AE) reports. Body weight, height and Tanner Stages will be collected to assess growth and physical development.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary end points consist of 4 items:
    1) Standard Lab Safety Data
    2) AE assessment
    3) body weight and height
    4) Tanner Stage
    Standard Lab Safety Data is performed at Baseline, and Months 1, 3, 6, 9, and 12. During study years 2 - 10 lab is collected at 6 month intervals. AE assessment is performed at Baseline, and Months 1, 3, 6, 9, and 12. During study years 2 - 10 AE assessment is completed at 6 month intervals. Body weight and height is recorded at Baseline, and Months 1, 3, 6, 9, and 12. During study years 2 - 10 body weight and height is collected at 6 month intervals. Tanner stage is assessed at Baseline and annually thereafter.
    E.5.2Secondary end point(s)
    The following efficacy parameters will be assessed:
    • Physician global evaluation of disease activity at each visit.
    • Number of joints with active arthritis at each visit.
    • Number of joints with limitation of motion at each visit.
    • Index of inflammation (C reactive protein [CRP]) and Erythrocyte Sedimentation Rate [ESR]) at each visit.
    • Childhood Health Assessment Questionnaire (CHAQ) at each visit.
    • Parent's Assessment of Physical Function (CHAQ Disability Index).
    • Parent's Assessment of Child's Arthritis Pain (CHAQ Discomfort Index, Visual Analog Scale [VAS]).
    • Parent's Global Assessment of Overall Wellbeing (CHAQ subsection Visual Analog Scale [VAS]).
    • JIA American College of Rheumatology (ACR) response and occurrence of JIA ACR disease flare at each visit.
    • JIA American Clinical Inactive Disease status and Clinical Remission of Medication at each visit.
    • Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS) 27-CRP and JADAS 27-ESR, and occurrence of JADAS minimum disease activity and inactive disease at each visit.
    •Eligibility of tapering defined per protocol for corticosteroids, MTX/lefluomide, and tofacitinib.
    •In subjects with sJIA: “Absence of Fever”, defined as absence of fever due to sJIA in the week preceding the assessment at each visit.
    • In subjects with Enthesitis Related Arthritis (ERA): Change from baseline in the Tender Entheseal Assessment, Modified Schober's Test, Overall Back Pain and Nocturnal Back Pain response at various visits.
    • In subjects with psoriatic arthritis (PsA): Change from baseline in body surface area (BSA) affected by psoriasis and Physician's Global Assessment (PGA) of psoriasis) at various visits.


    E.5.2.1Timepoint(s) of evaluation of this end point
    The Secondary endpoints (section 2.2.2) will be assessed at Baseline, and Months 1, 3, 6, 9, and 12. During study years 2 - 10 the assessments will be completed at 6 month intervals.
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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.8.3 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Belgium
    Brazil
    Canada
    Chile
    Germany
    Hungary
    Israel
    Italy
    Mexico
    New Zealand
    Peru
    Philippines
    Poland
    Russian Federation
    Slovakia
    South Africa
    Spain
    Switzerland
    Taiwan
    Turkey
    Ukraine
    United Kingdom
    United States
    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
    LVLS, according to the Protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years12
    E.8.9.2In all countries concerned by the trial months7
    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 Yes
    F.1.1Number of subjects for this age range: 340
    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: 170
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 170
    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
    Minors incapable of giving informed consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 340
    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)
    Subjects may participate in extension up to 10 years. It is expected that drug will be approved when subjects’ participation ends.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation PRINTO
    G.4.3.4Network Country Italy
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-17
    P. End of Trial
    P.End of Trial StatusRestarted
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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