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    Summary
    EudraCT Number:2011-004915-22
    Sponsor's Protocol Code Number:A3921145
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-05-17
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2011-004915-22
    A.3Full title of the trial
    A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF CP-690,550 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/162/2011
    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 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 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 Yes
    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 15.1
    E.1.2Level LLT
    E.1.2Classification code 10059176
    E.1.2Term 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
    The objective of this study is to determine the long term safety and tolerability of CP 690,550 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 CP 690,550 for treatment of the signs and symptoms of JIA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before patients are included in the study.
    Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Pediatric patients 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 RA disease activity to warrant use of CP 690,550 as a DMARD. Patients turning 18 years of age during participation in the qualifying/index study or subsequently will be eligible for participation in this study.
    2. The patient has discontinued disallowed concomitant medications for the required time prior to the first dose of study drug, as defined in Appendix 1 of the protocol, and is taking only those concomitant medications in doses and frequency allowed by the protocol.
    3. Fertility:
    a. Sterile male, or non sterile male. If the patient is a non sterile male on background medications (including DMARDs) that require male contraceptive precautions according to the local drug label and is sexually active with a female partner of child bearing potential, he and his partner must be practicing effective contraceptive measures.
    b. Females of childbearing potential must be using a reliable means of contraception (abstinence being a possible option) throughout the study and and for at least one ovulatory cycle after CP 690,550 treatment is discontinued.
    4. For patients receiving methotrexate (MTX) treatment, MTX may be administered either orally or parenterally at doses up to the lesser of 20 mg/wk or 15 mg/m2/week.
    5. For patients receiving leflunomide treatment, leflunomide may be administered according to the following dosing scheme:
    • 10 mg every other day for patients weighing less than 20 kg,
    • 10 mg every day for patients weighing between 20 and 40 kg,
    • 20 mg every day for patients weighing over 40 kg;
    Or as according to local standards.
    6. A negative QuantiFERON® TB Gold In Tube test performed within the 3 months prior to screening. A negative PPD test 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.
    7. Evidence of a personally signed and dated informed consent document with assent as appropriate indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
    8. Patients who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    Patients presenting with any of the following will not be included in the study:
    For patients who do not roll over into this study within 14 days of their last visit of their qualifying/index study (1 5): 1. Systemic JIA with active systemic features, persistent oligoarthritis, and undifferentiated JIA. 2. Blood dyscrasias, including:
    Hgb <10 g/dL or Hct <33%;WBC <3.0 x 10 to the power of 9/L;Neutrophil count <1.2 x 10 to the power of 9/L;Lymphocite count <0.5x10 to the power of 9/L;Platelet count <100 x 10 to the power of 9/L.
    3.Estimated GFR <40 mL/min/1.73 m2 calculated using the Schwartz formula at the Screening Visit. 4. Current or recent history of uncontrolled clinically significant renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, or neurological disease. 5. AST or ALT ≥1.5 times the upper limit of normal or any other clinically significant laboratory abnormality.
    For all patients: 6. History of any other rheumatic autoimmune disease. 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. Latent or active TB or any history of previous TB.
    b. Chronic infections.
    c. 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.
    d. Any treated infections within 2 weeks.
    e. A patient known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus.
    f. History of infected joint prosthesis with prosthesis still in situ.
    9. History of recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex. 10. Patients taking potent and moderate cytochrome P450 3A4 (CYP3A4) inhibitors. 11.Patients taking potent and moderate CYP3A4 inducers. 12. Participation in studies of investigational compounds (excluding qualifying/index study with CP 690,550) within 4 weeks or 5 half lives (whichever is longer) prior to the first dose of study drug. Patients 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]. Patients 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; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol during the study and for least one ovulatory cycle after the last dose of study medication.
    15. Intramuscular or intravenous corticosteroids in the 4 weeks preceding first dose of study medication. 16.Patients 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 of the protocol for further information regarding avoidance of household contacts who may be vaccinated). 17. Use of 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 28 days prior to the first dose of study medication. 19.Patients with a first degree relative with a hereditary immunodeficiency. 20. Patients 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 patient inappropriate for entry into this study. 24. Patients who are relatives of investigational site staff members.
    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 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.
    • Number of joints with active arthritis.
    • Number of joints with limitation of motion.
    • Index of inflammation (C reactive protein [CRP]).
    • Juvenile Arthritis Multidimensional Assessment Report (JAMAR).
    • Parent’s or child evaluation of overall wellbeing (JAMAR Visual Analog Scale [VAS] component).
    • Functional ability (JAMAR).
    • Health related quality of life (JAMAR).
    • American College of Rheumatology (ACR) pediatric response and flare criteria.
    • Inactive disease status parameters.
    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 No
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Czech Republic
    Germany
    Hungary
    Italy
    Poland
    Russian Federation
    Serbia
    Slovakia
    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
    Pfizer’s intent for this study is to make tofacitinib available to patients for as long as it is tolerated and deemed safe and for at least two years after first global marketing approval of tofacitinib for the treatment of JIA, or development of tofacitinib for JIA is discontinued. The total duration of an individual patient’s participation may vary depending upon when they entered the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months0
    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: 24
    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: 16
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 8
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 24
    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 Decision2012-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-03
    P. End of Trial
    P.End of Trial StatusOngoing
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    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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