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    Summary
    EudraCT Number:2017-003900-28
    Sponsor's Protocol Code Number:TOFA-PREDICT
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-01-25
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-003900-28
    A.3Full title of the trial
    A Stratification trial to determine key immunological factors predicting Tofacitinib efficacy and drug free remission in Psoriatic Arthritis (PsA). TOFA-PREDICT
    TOFA-PREDICT: Onderzoek naar biomarkers die de effectiviteit van het geneesmiddel Tofacitinib bij de behandeling van artritis psoriatica kunnen voorspellen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Stratification trial to determine key immunological factors predicting Tofacitinib efficacy and drug free remission in Psoriatic Arthritis (PsA). TOFA-PREDICT
    TOFA-PREDICT: Onderzoek naar biomarkers die de effectiviteit van het geneesmiddel Tofacitinib bij de behandeling van artritis psoriatica kunnen voorspellen
    A.3.2Name or abbreviated title of the trial where available
    TOFA-PREDICT
    TOFA-PREDICT
    A.4.1Sponsor's protocol code numberTOFA-PREDICT
    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 SponsorUMC Utrecht
    B.1.3.4CountryNetherlands
    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 supportPfizer
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUMC Utrecht
    B.5.2Functional name of contact pointRheumatology research
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 100
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584 CX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31887557357
    B.5.6E-mailreumatologie-research@umcutrecht.nl
    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
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form 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) 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 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 RoleComparator
    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 Methotrexate
    D.2.1.1.2Name of the Marketing Authorisation holderNA
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form 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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Enbrel
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form 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 Yes
    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 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: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Methotrexate
    D.2.1.1.2Name of the Marketing Authorisation holderNA
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    Subcutaneous 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
    psoriatic arthritis
    artritis psoriatica
    E.1.1.1Medical condition in easily understood language
    psoriatic arthritis
    artritis psoriatica
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Development of a molecular model associated with treatment response to tofacitinib in both csDMARD-naive and csDMARD-IR patients with active PsA
    E.2.2Secondary objectives of the trial
    - Determine the efficacy of tofacitinib versus MTX in csDMARD naïve patients with active PsA, with respect to individual clinical parameters as well as composite parameters.
    - Determine the efficacy of tofacitinib versus etanercept in csDMARD-IR patients with active PsA, with respect to individual clinical parameters as well as composite parameters.
    - Development of a molecular model associated with treatment response to methotrexate (in csDMARD naïve) and to etanercept (in csDMARD-IR) patients with active PsA.
    - Understanding the cellular and molecular pathways underlying clinical response to tofacitinib, MTX and etanercept in PsA.
    -Determine subclinical and radiographic efficacy of tofacitinib, MTX and etanercept on patients with active PsA.
    -Identification of novel potential therapeutic targets for the treatment of PsA.
    -Identification of biomarkers that predict longterm remission induced by tofacitinib, MTX and etanercept in PsA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    • Age 18-75 years old
    • Meets CASPAR criteria25 for psoriatic arthritis
    • Disease duration of at least 6 months
    • Evidence of active arthritis based upon ≥2 swollen joints and ≥2 tender joints
    • No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by all of the following:
    • A negative QuantiFERON-TB Gold (QFT-G) In-Tube test performed at or within 3 months prior to a given Screening visit. Subjects with a history of Bacille Calmette Guerin (BCG) vaccination will be tested with the QFT-G test.
    • A chest radiograph taken at or within the 3 months prior to screening without changes
    • suggestive of active TB infection as determined (and documented) by a qualified radiologist or pulmonologist as per local standard of care.
    • 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- TB Gold In-TubeR™ (QFT Gold test) need be obtained, but a chest radiograph must still be obtained if not done so within the prior 3 months.
    • Subjects who are already taking oral corticosteroids (but not injectable) may participate in the study:
    • Oral corticosteroids: Subjects who are already receiving oral corticosteroids must be on a stable dose of ≤10 mg/day of prednisone or equivalent for 4 weeks prior to first dose of study drug.
    • Injected (eg, intraarticular, intramuscular or intravenous) corticosteroids: Discontinued 4 weeks prior to the first dose of study drug.
    • Subjects who are already taking NSAIDs/COX-2 inhibitors may participate in the study provided that that the dose is stable for one week prior to first dose of study drug.
    • Subjects are to discontinue active psoriasis treatment prior to being enrolled in the study.
    • Biologics: All biologics which include investigational, those on the market or that will be available on the market during the enrolment of the study and are not otherwise mentioned (exclusion criteria) must be discontinued for a minimum of 6 months prior to the first dose of study drug.
    • Topical treatments that could affect psoriasis including: corticosteroids, tars, keratolytics, anthralin, vitamin D analogs, and retinoids must be discontinued for at least 2 weeks prior to the first dose of study drug.
    • Exceptions: the following topical treatments are allowed: non-medicated emollients for use over the whole body; topical steroids including hydrocortisone and hydrocortisone acetate £1% for the palms, soles, face, and intertriginous areas only; tar and salicylic acid preparations for the scalp only and shampoos free of corticosteroid for the scalp only.
    • UVB (narrowband or broadband) phototherapy must be discontinued at least 2 weeks prior to the first dose of study drug. Psoralens + UVA phototherapy (PUVA) must be discontinued for at least 4 weeks prior to the first dose of study drug.

    Inclusion criteria for the csDMARD-naïve group (Arm 1):
     No history of csDMARD use or bDMARD therapy use

    Inclusion criteria for the csDMARD-IR group (Arm 2):
     Current use of methotrexate on the highest tolerated dosage (max ≤25mg/wk) and on a stable dosage for at least 4 weeks prior to randomization. Subjects on methotrexate should be on an adequate and stable dose of folate supplementation (not less than 5 mg weekly based on folic acid, unless such doses would violate the local label guidelines or standard of care) for at least 4 weeks prior to the first dose of study drug. Subject must not have had previous serious toxicity while on methotrexate and not be expected to require evaluation for possible methotrexate toxicity (eg, require a liver biopsy for methotrexate toxicity) during the study.
     No history of bDMARD therapy use
     History of other csDMARD use is allowed (e.g. leflunomide, sulfasalazine) on the condition that these have been stopped at least 4 weeks prior to inclusion.
    E.4Principal exclusion criteria
    3.3 Exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:

    • Currently have pustular psoriasis only
    • Participation in other studies involving investigational drug(s) (Phases 1-4) within 4 weeks before the current study begins and/or during study participation. Participation in any observational studies during study participation.
    • Pregnant females, breastfeeding females, females of child-bearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least one ovulatory cycle after last dose of investigational product or females planning pregnancy. Women of childbearing potential must test negative for pregnancy prior to enrollment in this study.
    • Current or recent history of a severe, progressive or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic (including hypercholersterolemia), endocrine, pulmonary, cardiovascular, or neurologic disease.
    • Blood dyscrasias within 3 months prior to the first dose of study drug including confirmed:
    o Hemoglobin <10 g/dL; White blood cell count <3.0 x 109/L (<3000/mm3); Absolute neutrophil count ≤1.5 x 109/L(<1500/mm3);
    o Absolute lymphocyte count <1.0x109/L (<1000/mm3); Platelet count <100 x 109/L (<100,000/mm3).
    • Estimated Creatinine Clearance <40 ml/min based on Cockcroft formula.
    • Total bilirubin, AST or ALT more than 2.0 times the upper limit of normal at screening visit.
    • Have a known immunodeficiency or a first-degree relative with a hereditary immunodefiency.
    • Also excluded are subjects with history of any autoimmune rheumatic disease other than PsA (including systemic lupus erythematosis, mixed connective tissue disease, scleroderma, polymyositis) or known diagnosis of fibromyalgia, without approval by sponsor. Prior history of, or current rheumatic inflammatory disease other than PsA (e.g. gout, reactive arthritis, chronic Lyme disease)
    • History of an infected joint prosthesis at any time, with the prosthesis still in situ.
    • History 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.
    • History of recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
    • History of active infection (including localized infection) requiring:
    o Hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study medication.
    o Oral antimicrobial therapy within 2 weeks prior to the first dose of study medication.
    • Any prior treatment with non-B cell-specific lymphocyte depleting agents/therapies [eg, alemtuzumab (CampathR), efalizumab (RaptivaR)], alkylating agents (eg, cyclophosphamide or chlorambucil), or total lymphoid irradiation. 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 first dose of study drug and have normal CD19/20+ counts by FACS analysis.
    • Any subject who has been vaccinated with live or attenuated vaccines within the 6 weeks prior to the first dose of study medication or is to be vaccinated with these vaccines at any time during treatment or within 6 weeks following discontinuation of study medication.
    • A subject with any condition possibly affecting oral drug absorption, e.g. gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery such as gastric bypass. Procedures such as gastric banding, that simply divide the stomach into separate chambers, are NOT exclusionary.
    • History of alcohol or drug abuse unless in full remission for greater than 6 months prior to first dose of study medication.
    • Screening 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities (as determined by central reader) which may affect subject safety (eg, pattern of acute myocardial infarction, acute ischemia or serious arrhythmia) or interpretation of study results (eg, continuously paced ventricular rhythm or complete left bundle branch block).
    • A subject 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.
    • Significant trauma or surgery procedure within 1 month prior to first dose of study medication, or any planned elective surgery during the study period.
    E.5 End points
    E.5.1Primary end point(s)
    -ACR50 response (indicating a 50% reduction in joint disease activity) at week 12
    -Baseline molecular network profile (based on the composite systems medicine analysis)
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    E.5.2Secondary end point(s)
    7.1.2 Secondary study parameters/endpoints
    -treatment failure resulting in therapy cross-over (according to protocol) at week 12, week 24, week 52, week 104 .
    -change (50%) in the molecular network before treatment as compared to after (week 12, 52) treatment
    -change in composite clinical disease activity scores (MDA, ACR(20,50,70) response, DAS28) at week (12), 24, 52, 104. -change in individual clinical parameters that make up the composite scores (i.e. PASI score (reduction of 50%, 75%, 90%), joint count, CRP, ESR, QOL-measures) at week 12, 24, 52, 104
    -change in radiographic parameters: erosions and joint space narrowing (X-ray), bone edema and enthesitis (OMERACT score26) (MRI), inflammation and atherosclerotic burden (PET-CT)
    sustained remission/response leading to therapy cessation
    -sustained remission/response after therapy cessation
    -flare after therapy cessation
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 12 up to week 104
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    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 Yes
    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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned10
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state200
    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)
    standard of care
    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 Decision2018-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-04
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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