Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44157   clinical trials with a EudraCT protocol, of which   7327   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-002523-26
    Sponsor's Protocol Code Number:WI88341
    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:2015-11-13
    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 number2015-002523-26
    A.3Full title of the trial
    Effects of JAK inhibition on rheumatoid arthritis-related comorbidities: link between bone and vascular effects
    (investigator-initiated grant proposal)
    A JAK gátlás hatásai a rheumatoid arthritis társbetegségeire: a csont- és vascularis hatások kapcsolata. (vizsgáló által kezdeményezett kutatás)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of JAK inhibition on rheumatoid arthritis-related comorbidities: link between bone and vascular effects
    (investigator-initiated grant proposal)
    A JAK gátlás hatásai a rheumatoid arthritis társbetegségeire: a csont- és vascularis hatások kapcsolata. (vizsgáló által kezdeményezett kutatás)
    A.4.1Sponsor's protocol code numberWI88341
    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 SponsorArthritis Alapítvány
    B.1.3.4CountryHungary
    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 supportArthritis Alapítvány
    B.4.2CountryHungary
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationArthritis Alapítvány
    B.5.2Functional name of contact pointpresident
    B.5.3 Address:
    B.5.3.1Street AddressHomok str.
    B.5.3.2Town/ cityDebrecen
    B.5.3.3Post code4028
    B.5.3.4CountryHungary
    B.5.4Telephone number3652255091
    B.5.5Fax number3652255091
    B.5.6E-mailreuma.titkarsag@med.unideb.hu
    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.3.1Product nameTofacitinib
    D.3.2Product code CP-690,55-10
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 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
    Rheumatoid Arthritis
    E.1.1.1Medical condition in easily understood language
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid 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
    Assessing the vascular imaging markers FMD, ccIMT and PWV at baseline and then after 1, 6 and 12 months of therapy.
    Assessing the vasculature and joints by whole body PET-CT imaging at baseline and after 12 months of therapy. Identifying correlation of synovial and vascular inflammatory changes assessed by PET-CT.
    Recording any cardio- or cerebrovascular disease occurring at any time during the follow-up and to extend the follow-up for 5 years after baseline.
    E.2.2Secondary objectives of the trial
    Assessing bone density by DEXA, and, in order to determine bone density in trabecular and cortical bone separately, also by radius pqCT at baseline and after 6 and 12 months of treatment.
    Assessing laboratory markers of bone formation (osteocalcin), resorption (NTX, CTX), as well as molecular markers of osteoimmunology (RANKL, OPG, DKK-1 and sclerostin) at baseline and after 1, 3, 6 and 12 months of therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adults (>18 years) male or female
    - Obtained consent from patient in written form
    - Existing rheumatoid arthritis for more than 6 months (DAS28 >3,2), with preceding biological therapy for at least 3 months
    - Patients able to attend to control examinations and fulfil the requirements of protocol
    - Patients able to understand and fill the optional questionnaires
    E.4Principal exclusion criteria
    - Uncertain diagnosis
    - Severe allergic or anaphylactic raction, or hypersensitivity to any component of tofacitinib
    - Any active or clinically significant recurrent infection
    - Contraindications of tofacitinib therapy (heart failure, SLE, demyelinating diseases, history of malignacy in 10 years, kidney failure, liver failure)
    - Pregnancy
    - History of current symptoms of any untreated disease (e.g. unstable hypertension, diabetes mellitus), which puts the patient at risk in opinion of the investigator doctor
    - Participation in other studies involving investigational drug(s) (Phases 1-4) within 4 weeks before the current study begins and/or during study participation.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint: surrogate markers of vascular pathology after 12 months of TOF treatment.

    Assessing clinical activity by DAS28, and obtaining peripheral blood samples for detailed analysis of disease activity and metabolic profile including BMI, CRP, ACPA, RF, homocysteine, full lipid profile, inflammatory HDL, paraoxonase 1 (PON-1), folate, vitamin B12, insulin, resistin, adiponectin, leptin, as well as methylene tetrahydrofolate (MTHFR) and paraoxonase gene polymorphisms.
    Assessing PWV indicating vascular stiffness at baseline and then after 6 and 12 months of therapy.
    Assessing the vasculature and joints by whole body PET-CT imaging at baseline and after 12 months of therapy. Correlation of synovial and vascular inflammatory changes will be assessed by PET-CT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Clinical assessment and lab will be performed at baseline, Months 6 and 12.
    Vascular imaging (ccIMT, PWV, FMD) will be assessed at baseline, Months 6 and 12. PET-CT will be performed twice, at baseline and Months 12.
    E.5.2Secondary end point(s)
    Secondary endpoint: surrogate markers of bone pathology after 12 months of TOF treatment.

    Assessing bone density by DEXA, and, in order to determine bone density in
    trabecular and cortical bone separately, also by radius pqCT at baseline and after 12 months of treatment.

    Assessing laboratory markers of bone formation (osteocalcin), resorption (NTX, CTX), and molecular markers of osteoimmunology (RANKL, OPG, DKK-1 and sclerostin) at baseline and after 6 and 12 months of therapy.
    E.5.2.1Timepoint(s) of evaluation of this end point
    DEXA and pqCT will perfomed at baseline and Month 12.
    Bone markers will be assessed at baseline, Months 6 and 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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) 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 Yes
    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 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
    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 months0
    E.8.9.1In the Member State concerned days0
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state30
    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 - Following the end of the study patients will receive normal standard of care treatments
    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 Decision2016-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-02
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA