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    Summary
    EudraCT Number:2015-000581-58
    Sponsor's Protocol Code Number:BioBioV4.0
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-16
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2015-000581-58
    A.3Full title of the trial
    A Randomized, Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action
    Randomizovaná studie biomarkerů predikce terapeutické odpovědi pacientů s revmatoidní artritidou na biologickou léčbu
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized,Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action
    A.3.2Name or abbreviated title of the trial where available
    BioBio
    A.4.1Sponsor's protocol code numberBioBioV4.0
    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 SponsorRevmatologicky ustav Praha
    B.1.3.4CountryCzech Republic
    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 supportMedical University of Vienna
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRevmatologicky ustav Praha
    B.5.2Functional name of contact pointCoordinator
    B.5.3 Address:
    B.5.3.1Street AddressNa Slupi 4
    B.5.3.2Town/ cityPrague 2
    B.5.3.3Post code12850
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number00420732107647
    B.5.5Fax number00420224 914 451
    B.5.6E-mailolejarova@revma.cz
    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 Remicade
    D.2.1.1.2Name of the Marketing Authorisation holderMSD
    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.3.1Product nameRemicade
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.9.4EV Substance CodeSUB02681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 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 Orencia
    D.2.1.1.2Name of the Marketing Authorisation holderBMS
    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.3.1Product nameOrencia
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNABATACEPT
    D.3.9.1CAS number 332348-12-6
    D.3.9.4EV Substance CodeSUB20635
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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: 3
    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 Ro-Actemra
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    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.3.1Product nameRo Actemra
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtocilizumabum
    D.3.9.1CAS number 375823-41-9
    D.3.9.3Other descriptive nameTOCILIZUMAB
    D.3.9.4EV Substance CodeSUB20313
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody against IL-6
    D.IMP: 4
    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 Mabthera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    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.3.1Product nameMabthera
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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.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
    Revmatoidní artritida
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis
    Revmatoidní artritida
    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
    To identify a set of clinical and/or biological markers that allows the identification of the optimal biological mode of action for a given patient with rheumatoid arthritis.
    Primary endpoint: Absolute change in the Simplified Disease Activity Index (SDAI) after 24 weeks.
    Cílem studie je identifikovat klinické a biologické markery predikce optimální odpovědi na biologickou léčbu u pacientů s revmatoidní artritidou.
    Primárním cílem je absolutní změna aktivity RA hodnocená pomocí Simplified Disease Activity Index (SDAI) po 24 týdnech.
    E.2.2Secondary objectives of the trial
    - Relative change in the SDAI after 24 weeks in percent.
    - Absolute and relative change in the Clinical Disease Activity Index (CDAI) after 24 weeks in percent.
    - Absolute and relative change in the Disease Activity Score 28 (DAS28) after 24 weeks in percent.
    - Achieving an SDAI or CDAI response (50%, 70%, 85%)
    - Achieving a EULAR response
    - Achieving an ACR response (20%, 50%, 70%)
    - Change in quality of life (EuroQoL-5D, SF-36) and physical function (HAQ)
    - Change in fatigue and sleep
    - Proportion achieving a low disease activity state (SDAI ≤11) after 24 weeks
    - Proportion achieving a remission state (SDAI ≤3.3) after 24 weeks
    - Radiographic progression over 6 months / 12 months
    - Relativní změna SDAI po 24 týdnech (%)
    - Absolutní a relativní změna Clinical Disease Activity Index (CDAI) po 24 týdnech (%)
    - Absolutní a relativní změna Disease Activity Score 28 (DAS28) po 24 týdnech (%)
    - Dosažení odpovědi SDAI nebo CDAI (50%, 70%, 85%)
    - Dosažení odpovědi podle EULAR
    - Dosažení odpovědi podle ACR response (20%, 50%, 70%)
    - Změna kvality života (EuroQoL-5D, SF-36) a fyzické funkce (HAQ)
    - Změna, resp. zlepšení únavy a spánku
    - Proporce pacientů s nízkou aktivitou nemoci (SDAI ≤ 11) po 24 týdnech
    - Radiografická progrese po 6 měsících/ 12 měsících
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Men and women, ≥18 and ≤75 years of age, capable of understanding and signing an informed consent.
    2) Classifiable RA according to the 2010 ACR/EULAR criteria or 1987 ARA criteria (present or past)
    3) Duration of RA ≤3 years
    4) Ongoing conventional DMARD therapy with methotrexate (at least 20 mg/week, or lower if not tolerated in higher doses) or leflunomide (≥ 100mg/week), for ≥6 months, or ≥3 months with documented worsening of disease activity.
    5) Clinical Disease Activity Index (CDAI)≥15 corresponding to moderate to severe disease activity.
    1) Muži a ženy ≥18 a ≤75 let věku, schopní porozumění a podpisu informovaného souhlasu.
    2) RA klasifikovatelná podle kritérií ACR/EULAR 2010 nebo kritérií ARA 1987 (v současnosti nebo v minulosti)
    3) Délka trvání RA ≤3 let
    4) Pokračující terapie konvenčními DMARDs - methotrexatem (v dávce alespoň 20mg týdně nebo nižší v případě intolerance vyšších dávek) nebo leflunomidem (≥100mg/ týdně) po dobu ≥6 měsíců nebo ≥3 měsíce s dokumentovaným zhoršením aktivity nemoci
    5) Clinical Disease Activity Index (CDAI) ≥15, odpovídající střední nebo vysoce závažné aktivitě nemoci
    E.4Principal exclusion criteria
    1) Be incapacitated, largely or wholly bedridden, or confined to a wheelchair, or have little or no ability for self care.
    2) Tělesná hmotnost nad 100 kg
    3) Užívání glukokortikoidů >10 mg prednisonu denně nebo ekvivalentu
    4) Předcházející léčba revmatického onemocnění:
    a) intramusculární nebo intraartikulární injekce glukokortikoidů v posledním měsíci
    b) monoklonální protilátky nebo jejich fragmenty, registrovanými nebo ve fázi klinického
    zkoušení
    c) jakékoliv léky ve fázi klinického zkoušení během 5 měsíců nebo po dobu 5 poločasů zkoušeného
    léku před screeningem, podle toho, co je delší
    d) Azathioprin nebo jiné cytotoxické látky
    5) Podávání humánního/ myšího rekombinantního produktu nebo známá alergie na myší produkty v anamnéze.
    6) Známá pozitivita viru lidské imunodeficience (HIV) nebo pozitivní antigen HBsAg nebo protilátky proti viru hepatitidy C.
    7) Hypergamaglobulinémie před screeningem
    8) Anamnéza abúzu alkoholu nebo jiných látek v posledních 6 měsících.
    9) Současné nebo minulé
    a) serious infections (such as, but not limited to hepatitis, pneumonia, or pyelonephritis) in the
    previous 3 months.
    b) opportunistic infections (eg, herpes zoster, cytomegalovirus, Pneumocystis carinii, aspergillosis,
    histoplasmosis, or mycobacteria other than TB) within 12 months prior to screening.
    c) a chronic or recurrent infectious disease (eg, chronic renal infection, chronic chest infection,
    COPD, sinusitis, recurrent urinary tract infection, open, draining or infected skin wound or ulcer
    etc.).
    10) Have undergone any joint replacement surgery.
    11) Be men and women of childbearing potential without use of adequate birth control measures
    (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide,
    implantable or injectable contraceptives or surgical sterilization), and willingness to continue this
    precaution for the duration of the study until 6 months after receiving the last medication.
    12) Be considered ineligible according to the tuberculosis (TB) eligibility assessment and screening, or
    show a positive test for latent Tbc using Quantiferon assay, unless treatment with INH has been installed for at least 2 weeks prior to starting trial drug.
    13) Show evidence of malignancy, or lymphoproliferative disease, or any history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence.
    14) Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
    15) Be unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access.
    16) Have presence of a transplanted solid organ (with the exception of a corneal transplant > 3 months prior to screening).
    17) Have a concomitant diagnosis or history of congestive heart failure (NYHA class III or IV) or diverticulitis.
    18) Have a known history of a demyelinating disease, such as multiple sclerosis.
    19) Be women who are pregnant, nursing, or planning pregnancy within 6 months after the last infusion
    1) Be incapacitated, largely or wholly bedridden, or confined to a wheelchair, or have little or no ability for self care.
    2) Tělesná hmotnost nad 100 kg
    3) Užívání glukokortikoidů >10 mg prednisonu denně nebo ekvivalentu
    4) Předcházející léčba revmatického onemocnění:
    a) intramusculární nebo intraartikulární injekce glukokortikoidů v posledním měsíci
    b) monoklonální protilátky nebo jejich fragmenty, registrovanými nebo ve fázi klinického
    zkoušení
    c) jakékoliv léky ve fázi klinického zkoušení během 5 měsíců nebo po dobu 5 poločasů zkoušeného
    léku před screeningem, podle toho, co je delší
    d) Azathioprin nebo jiné cytotoxické látky
    5) Podávání humánního/ myšího rekombinantního produktu nebo známá alergie na myší produkty v anamnéze.
    6) Známá pozitivita viru lidské imunodeficience (HIV) nebo pozitivní antigen HBsAg nebo protilátky proti viru hepatitidy C.
    7) Hypergamaglobulinémie před screeningem
    8) Anamnéza abúzu alkoholu nebo jiných látek v posledních 6 měsících.
    9) Současné nebo minulé
    a) serious infections (such as, but not limited to hepatitis, pneumonia, or pyelonephritis) in the
    previous 3 months.
    b) opportunistic infections (eg, herpes zoster, cytomegalovirus, Pneumocystis carinii, aspergillosis,
    histoplasmosis, or mycobacteria other than TB) within 12 months prior to screening.
    c) a chronic or recurrent infectious disease (eg, chronic renal infection, chronic chest infection,
    COPD, sinusitis, recurrent urinary tract infection, open, draining or infected skin wound or ulcer
    etc.).
    10) Have undergone any joint replacement surgery.
    11) Be men and women of childbearing potential without use of adequate birth control measures
    (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide,
    implantable or injectable contraceptives or surgical sterilization), and willingness to continue this
    precaution for the duration of the study until 6 months after receiving the last medication.
    12) Be considered ineligible according to the tuberculosis (TB) eligibility assessment and screening, or
    show a positive test for latent Tbc using Quantiferon assay, unless treatment with INH has been installed for at least 2 weeks prior to starting trial drug.
    13) Show evidence of malignancy, or lymphoproliferative disease, or any history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence.
    14) Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
    15) Be unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access.
    16) Have presence of a transplanted solid organ (with the exception of a corneal transplant > 3 months prior to screening).
    17) Have a concomitant diagnosis or history of congestive heart failure (NYHA class III or IV) or diverticulitis.
    18) Have a known history of a demyelinating disease, such as multiple sclerosis.
    19) Be women who are pregnant, nursing, or planning pregnancy within 6 months after the last infusion
    E.5 End points
    E.5.1Primary end point(s)
    Absolute change in the Simplified Disease Activity Index (SDAI) after 24 weeks.
    Absolutní změna Simplified Disease Activity Index (SDAI) po 24 týdnech
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks, 48 weeks
    24 týdnů, 48 týdnů
    E.5.2Secondary end point(s)
    - Relative change in the SDAI after 24 weeks in percent.
    - Absolute and relative change in the Clinical Disease Activity Index (CDAI) after 24 weeks in percent.
    - Absolute and relative change in the Disease Activity Score 28 (DAS28) after 24 weeks in percent.
    - Achieving an SDAI or CDAI response (50%, 70%, 85%)
    - Achieving a EULAR response
    - Achieving an ACR response (20%, 50%, 70%)
    - Change in quality of life (EuroQoL-5D, SF-36) and physical function (HAQ)
    - Change in fatigue and sleep
    - Proportion achieving a low disease activity state (SDAI ≤11) after 24 weeks
    - Proportion achieving a remission state (SDAI ≤3.3) after 24 weeks
    - Radiographic progression over 6 months / 12 months
    - Relativní změna SDAI po 24 týdnech (%)
    - Absolutní a relativní změna Clinical Disease Activity Index (CDAI) po 24 týdnech (%)
    - Absolutní a relativní změna Disease Activity Score 28 (DAS28) po 24 týdnech (%)
    - Dosažení odpovědi SDAI nebo CDAI (50%, 70%, 85%)
    - Dosažení odpovědi podle EULAR
    - Dosažení odpovědi podle ACR response (20%, 50%, 70%)
    - Změna kvality života (EuroQoL-5D, SF-36) a fyzické funkce (HAQ)
    - Změna, resp. zlepšení únavy a spánku
    - Proporce pacientů s nízkou aktivitou nemoci (SDAI ≤ 11) po 24 týdnech
    - Proporce pacientů s remisí (SDAI ≤ 3,3) po 24 týdnech
    - Radiografická progrese po 6 měsících/ 12 měsících
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months, 12 Months
    6 měsíců, 12 měsíců
    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 Yes
    E.6.4Safety Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Predictive role of biomarkers for the response to the biological treatment with different mode of action
    Prediktivní úloha biomarkerů pro odpověď na biologickou léčbu s různým mechanismem účinku
    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 trial4
    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 years3
    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 years3
    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 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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state40
    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)
    Patients will be treated in a standard way - according to the national guidelines for the management of rheumatoid arthritis
    Pacienti budou pokračovat ve standardní léčbě podle oficiálních doporučení pro léčbu revmatoidní artritida
    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 Decision2015-09-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-01
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