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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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).

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    Summary
    EudraCT Number:2011-004914-40
    Sponsor's Protocol Code Number:A3921103
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-05-17
    Trial results View 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 number2011-004914-40
    A.3Full title of the trial
    AN OPEN-LABEL MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CP-690,550 IN PEDIATRIC PATIENTS FROM 2 TO LESS THAN 18 YEARS OF AGE WITH JUVENILE IDIOPATHIC ARTHRITIS (JIA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1 Study to Characterize the Pharmacokinetics of CP-690,550 in Pediatric JIA Patients Aged 2-18
    A.4.1Sponsor's protocol code numberA3921103
    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, NY 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 number001800718021
    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
    E.1.1.1Medical condition in easily understood language
    JUVENILE IDIOPATHIC 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
    To characterize the PK and safety of CP 690,550 following multiple oral doses in pediatric patients (from 2 to less than 18 years) with active JIA.
    E.2.2Secondary objectives of the trial
    To evaluate taste acceptability of the oral formulation of CP 690,550 in pediatric patients with 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:
    Pediatric patients with JIA aged from 2 to less than 18 years with active JIA (extended oligoarthritis, polyarthritis rheumatoid factor positive or negative, psoriatic arthritis, enthesitis related arthritis), in 5 or more joints (using ACR definition of active joint) at the time of the first study drug administration.
    1. The patient has discontinued prohibited concomitant medications for the required time prior to the first dose of study drug, as defined in Appendix 4 of the protocol, and is taking only those concomitant medications in doses and frequency allowed by the protocol.
    2. Fertility:
    a. Sterile male, or non sterile male. If the patient is a non sterile male receiving MTX treatment and is sexually active with a female partner of child bearing potential, he and his partner must be using an acceptable method of contraception during the study, and after therapy for the duration according to the local drug label.
    b. Females of childbearing potential must be using an acceptable method of contraception (abstinence being a possible option) starting at least 14 days prior to the first dose of study drug and continuing for at least one ovulatory cycle after the last dose of study drug.
    3. For patients receiving MTX treatment, minimum duration of therapy is 4 months and dose stable for at least 6 weeks prior to first dose of study drug. MTX may be administered either orally or parenterally at doses up to the lesser of 20 mg/wk or 15 mg/m2/week.
    4. 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.
    5. Written informed consent for study participation obtained from parents or legal guardian, with assent as appropriate by the patient, depending on the level of the patient’s understanding.
    6. Patients who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    1.Systemic JIA, persistent oligoarthritis, undifferentiated arthritis. 2.Hgb<11 g/dL or Hct<33% (b) WBC <3.0 x 10 to the power of 9/L ; Neutrophil count<1.2 x 10 to the power of 9/L; Lymphocyte count<0.5x10 to the power of 9/L; Platelet count<100x 10 to the power of 9/L. 3. Estimated GFR <40 mL/min by Schwartz formula. 4.Current or recent history of uncontrolled clinically significant renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, or neurological disease. 5.AST or ALT≥1.5XULN or other clinically significant laboratory abnormality. 6.History of any other rheumatic autoimmune disease. 7.History or current symptoms suggestive of any lymphoproliferative disorder (eg, Epstein Barr Virus related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease). 8 Infections: Latent or active TB or any history of previous TB; Chronic infections; Any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within the 6months prior to the first dose of study drug; Any treated infections within 2weeks; Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus; History of infected joint prosthesis with prosthesis still in situ. 9History of recurrent or disseminated herpes zoster or disseminated herpes simplex. 10. Any condition possibly affecting drug absorption. 11.Potent and moderate CYP3A4 inhibitors. 12.Potent and moderate CYP3A4 inducers. 13.Following treatments are disallowed during this study and must be discontinued prior to first dose of study drug for at least:Anakinra and Etanercept, for 4weeks; Adalimumab, for 6weeks;Infliximab,for 8weeks; Golimumab, for 10weeks; Abatacept, tocilizumab and certolizumab pegol, for 12weeks; Auranofin (oral gold), aurothioglucose (injectable gold), aurothiomalate (injectable gold), for 8weeks; Sulfasalazine, d penicillamine, azathioprine, chloroquine, hydroxychloroquine, cyclosporine, tacrolimus, and staphylococcal protein A immuno absorbant pheresis columns, for 4weeks; 14.Following treatments are disallowed during this study and must be discontinued prior to first dose of study drug for at least: Leflunomide, for 8weeks. Alternatively, a washout procedure may be used; Ustekinumab, for 12weeks; Alefacept must be discontinued for 8weeks; UVB phototherapy for at least 2weeks. Psoralens +UVA phototherapy (PUVA) for 4 weeks.
    15.Participation in studies of investigational compounds within 4 weeks or 5 half lives (whichever is longer) prior to the first dose of study drug or at any time during the study. 16.Any prior treatment with non B cell specific lymphocyte depleting agents/therapies [eg, almetuzuma, 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. 17.Pregnant or nursing females; females of childbearing potential unwilling or unable to use an acceptable method of contraception from at least 14 days prior to the first dose of study drug and for least one ovulatory cycle after the last dose. 18.Intramuscular, intravenous or intraarticular corticosteroids in the 4 weeks preceding first dose of study drug. 19.Vaccination with live or attenuated vaccines within the 6 weeks prior to the first dose of study drug or is vaccination with these vaccines at any time during treatment or within 6 weeks following discontinuation of study drug. 20.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 drug. 21.Herbal supplements must be discontinued at least 28 days prior to the first dose of study drug. 2.History of sensitivity to heparin or heparin-induced thrombocytopenia. 23.First degree relative with a hereditary immunodeficiency. 24.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. 25.Recent (within 28 days prior to first dose of study drug) significant trauma or major surgery. 26.Unwilling or unable to comply with the Lifestyle Guidelines.27.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.28.Patients who are investigational site staff members or relatives of those site staff members or patients who are Pfizer employees directly involved in the conduct of the trial.
    E.5 End points
    E.5.1Primary end point(s)
    - Oral clearance (CL/F) on Day 5.

    - Safety and tolerability.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline/Day 1 and Day 5
    E.5.2Secondary end point(s)
    - AUCt, Cmax, tmax and half life.

    -Evaluation of taste acceptability of oral formulation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline/Day 1 and Day 5
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    pharmacokinetics, safety and tolerability
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    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
    Argentina
    Czech Republic
    Germany
    Hungary
    Italy
    Mexico
    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
    LVLS
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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 will be eligible to enrol into A3921145, long-term efficacy study.
    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 StatusCompleted
    P.Date of the global end of the trial2015-12-04
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