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    Summary
    EudraCT Number:2016-000568-41
    Sponsor's Protocol Code Number:GS-US-417-0301
    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:2016-10-21
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2016-000568-41
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
    Randomizovaná, dvojitě zaslepená, placebem a aktivně kontrolovaná, multicentrická studie fáze 3 hodnotící účinnost a bezpečnost filgotinibu podávaného po dobu 52 týdnů v kombinaci s metotrexátem subjektům se středně až silně aktivní revmatoidní artritidou, které mají neadekvátní odpověď na metotrexát
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
    A.4.1Sponsor's protocol code numberGS-US-417-0301
    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 SponsorGilead Sciences, Inc.
    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 supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441223897476
    B.5.6E-mailclinical.trials@gilead.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.3.1Product nameFilgotinib
    D.3.2Product code GS-6034
    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 INNFILGOTINIB
    D.3.9.3Other descriptive nameFILGOTINIB
    D.3.9.4EV Substance CodeSUB182273
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 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 Humira (adalimumab) 40 mg s.c. injection
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Ltd
    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 nameAdalimumab
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.3Other descriptive nameHumira
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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 typeRecombinant human monoclonal antibody
    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 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 nameFilgotinib
    D.3.2Product code GS-6034
    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 INNFILGOTINIB
    D.3.9.3Other descriptive nameFILGOTINIB
    D.3.9.4EV Substance CodeSUB182273
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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: 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 Humira (adalimumab) 40mg in 0.4 ml s.c. injection
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Ltd
    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 nameAdalimumab
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    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 Yes
    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 typeRecombinant human monoclonal antibody
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 4
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderately to severely active rheumatoid arthritis
    E.1.1.1Medical condition in easily understood language
    Rheumatoid arthritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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
    The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the proportion of subjects achieving an American College of Rheumatology 20% improvement response (ACR20) at
    Week 12
    E.2.2Secondary objectives of the trial
    - To evaluate the effects of filgotinib versus placebo as measured by the proportion of subjects achieving Disease Activity Score for 28 joint count using c-reactive protein (DAS28[CRP]) ≤3.2 at Week 12
    - To evaluate the effect of filgotinib versus placebo on physical function as measured by change from Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) score at Week 12
    - To evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of RA as measured by the proportion of subjects achieving DAS28 (CRP)<2.6 at Week 24
    - To evaluate the effects of filgotinib versus placebo on preservation of joint structure as measured by change from Baseline in the van der Heijde modified Total Sharp Score (mTSS) at Week 24
    - To evaluate the effects of filgotinib versus adalimumab for the treatment of signs and symptoms of RA as measured by the proportion of subjects achieving DAS28 (CRP) ≤ 3.2 at Week 12
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Carotid Artery Ultrasound: When available at selected sites, all enrolled subjects at those sites will take part in carotid artery ultrasounds at Day 1(+ 7 day window) and Weeks 24 and 52 (± 7 day window). An exploratory lab panel will also be performed for all subjects at the siteswhere ultrasounds will be performed,, according to the Laboratory Assessments in Appendix 6. Further details of how the procedure will be performed and evaluated will be provided to participating sites in a separate manual.

    Optional MRI sub-study: At selected sites, a subset of subjects may consent to participate in an optional MRI substudy (see Section 3.9). For those subjects, an MRI of a single hand and wrist will be performed post-randomization within 7 days of the first dose and repeated at Week 12. Hand and wrist of each subject will be imaged using a 1.5 Tesla or 3 Tesla whole-body MRI scanner. Images will be centrally read by 2 radiologists who are
    blinded with regard to visit sequence, subject treatment assignment and the alternate reader’s scores.

    Inclusion criteria for MRI substudy
    1) Subjects must fulfill entry criteria to the main study as described in protocol sections 4.2 and 4.3 above, and must provide written, informed consent to the MRI substudy.
    2) RA involvement of a minimum of one hand or wrist as confirmed by the investigator at screening; Screening (the same hand/wrist should be imaged at the subsequent MRIs)
    3) Subject’s baseline MRI must fulfill radiologic entry criteria (by central reading) of either:
    a) Definitive intra-articular MRI synovitis (RAMRIS Grade ≥2 in any applicable hand or wrist joint, or RAMRIS Grade 1 in ≥2 applicable joints)
    b) Definitive MRI osteitis (RAMRIS Grade ≥1) in any applicable bone.

    Exclusion criteria for MRI substudy
    1) Inability to undergo an MRI examination (e.g., presence of a pacemaker, defibrillator, or other contraindicated implanted metallic device, such as anterior interbody cages, aneurysm clip or pedicle screws, severe claustrophobia or weight >350 lb)
    2) Metallic pigment-containing tattoos in the area of examination
    3) Known allergy to gadolinium-based contrast agents
    4) Difficult peripheral intravascular access
    E.3Principal inclusion criteria
    For a complete list of study inclusion criteria, please refer to study protocol (sections 4.2):
    1) Male or female subjects who are ≥18 years of age, on the day of signing informed consent.
    2) Have a diagnosis of RA (2010 ACR/EULAR criteria for RA), and are ACR functional class I-III .
    3) Have ≥6 swollen joints (from a SJC66) and ≥6 tender joints (from a TJC68) at both Screening and Day 1 (need not be the same joints).
    4) Must meet at least one of the Screening parameters defined in the protocol (section 4.2) regarding the number of joint erosions and serum CRP
    5) Ongoing treatment with a stable dose of MTX as described in the protocol (section 4.2)
    6) Females of childbearing potential must have a negative pregnancy test at screening and Day 1
    7) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception.
    8) Lactating female subjects must agree to discontinue nursing from Screening through the end of their study participation.
    9) Meet one of the tuberculosis (TB) Screening criteria described in the protocol (section 4.2)
    10) Able and willing to sign the informed consent as approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB). Written consent must be provided before initiating any screening evaluations. Subjects must have read and understood the informed consent form (ICF), must fully understand the requirements of the study, and must be willing to comply with all study visits and assessments; subjects who cannot read or
    understand the ICF may not be enrolled by a guardian or any other individual.
    11) Able and willing to perform subcutaneous self-injections or have a caregiver able, willing and available to administer the injections.
    12) Subjects receiving non-prohibited medication for any reason should be on a stable dose (defined as no change in prescription) within 7 days or 5 half-lives (whichever is longer) prior to the first administration of study drug on Day 1.
    E.4Principal exclusion criteria
    For a complete list of study exclusion criteria, please refer to study protocol (Sections 4.3):
    1) Prior treatments for RA as defined in Section 4.3 of the protocol
    2) Known hypersensitivity or allergy to the study drug(s), its metabolites, or formulation excipients.
    3) Oral steroids at a dose >10 mg/day of prednisone (or equivalent) or a prescription for oral steroids which has changed within 4 weeks of Day 1.
    4) Receipt of an intra-articular or parenteral corticosteroid injection within 4 weeks prior to Day 1.
    5) Use of nonsteroidal anti-inflammatory drugs (NSAIDs) which have not been at a stable dose (defined as no change in prescription) for at least 2 weeks prior to Day 1. NOTE: subjects are permitted to take acetylsalicylic acid at a dose of ≤325mg daily for cardiac prophylaxis, or occasional NSAIDs for non-RA indications (eg, headache).
    6) Administration of a live/attenuated vaccine within 30 days prior to Day 1, or planned during the study.
    7) Participation in any clinical study of an investigational drug/device within 4 weeks or 5 half-lives prior to Screening, whichever is longer. Exposure to investigational biologics should be discussed with the Sponsor.
    8) Have undergone surgical treatments for RA, including synovectomy or arthroplasty in >4 joints
    9) Have any chronic, uncontrolled medical condition, which would put the subject at increased risk during study participation, such as uncontrolled: diabetes, hypertension, morbid obesity, thyroid, adrenal, pulmonary, hepatic, renal, neurologic or psychiatric disease, or other disease
    of concern, as per judgment of investigator 10) Have a history of major surgery (requiring regional block or general anesthesia) within the last 3 months prior to Screening or planned major surgery during the study.
    11) Have a moderately to severely active, generalized musculoskeletal disorder that would interfere with assessment of study parameters or increase risk to the subject by participating in the study.
    12) Active autoimmune disease that would interfere with assessment of study parameters or increase risk to the subject by participating in the study.
    13) History of or current moderate to severe congestive heart failure (New York Heart Association [NYHA] class III or IV), or within the last 6 months, a cerebrovascular accident, myocardial infarction, unstable angina, unstable arrhythmia, new or significant ECG finding at Screening, or any other cardiovascular condition which, in the opinion of the investigator, would put the subject at risk by participation in the study.
    14) History of malignancy within the past 5 years prior to Screening
    15) History of lymphoproliferative disease or current lymphoproliferative disease
    16) History of gastrointestinal perforation.
    17) History of organ or bone marrow transplant.
    18) Positive serology for human immunodeficiency virus (HIV) 1 or 2.
    19) Evidence of active Hepatitis C Virus (HCV) infection.
    20) Evidence of active Hepatitis B Virus (HBV) infection.
    21) History of opportunistic infection, or immunodeficiency syndrome, which would put the subject at risk, as per investigator judgment.
    22) Active infection that is clinically significant, as per judgment of the investigator, or any infection requiring hospitalization or treatment with intravenous anti-infectives within 60 days of Screening; or any infection requiring oral anti‑infective therapy within 30 days of Screening.
    23) Currently on any therapy for chronic infection. Past history of disseminated Staphylococcus aureus or disseminated Herpes simplex infection.
    24) History of symptomatic herpes zoster infection within 12 weeks prior to Screening or have history of disseminated/complicated herpes zoster infection.
    25) History of an infected joint prosthesis or other implanted device with retention of the prosthesis or device in situ.
    26) Current drug, tobacco or alcohol abuse, per investigator judgement.
    27) Any known condition or contraindication as addressed in the local labeling for adalimumab and/or MTX that would preclude the subject from participating in this study.
    28) Any condition including active fibromyalgia that based on the investigator’s opinion would make it difficult to appropriately assess RA activity for the purposes of this study.
    29) Any condition or circumstances which in the opinion of the Investigator or Sponsor may make a subject unlikely or unable to complete the study or comply with study procedures and requirements.
    30) Use of prohibited medication as outlined in section 5.5
    31) Significant blood loss (>450 mL) or transfusion of any blood product within 12 weeks prior to Day 1.
    32) Tests performed at the central laboratory at Screening as defined in study protocol (Section 4.3)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is the proportion of subjects who achieve an ACR20 response at Week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    The key secondary endpoints for this study are:
    - The proportion of subjects who achieve DAS28 (CRP)≤3.2 at Week 12
    - Change from Baseline in the HAQ-DI score at Week 12
    - The proportion of subjects who achieve DAS28 (CRP)<2.6 at Week 24
    - Change from Baseline in mTSS at Week 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12 and Week 24
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo Yes
    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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Australia
    Belgium
    Brazil
    Canada
    Chile
    Colombia
    Czech Republic
    France
    Germany
    Hong Kong
    Hungary
    India
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    New Zealand
    Peru
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Switzerland
    Taiwan
    Thailand
    Ukraine
    United Kingdom
    United States
    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
    End of Study is defined as when the last subject has completed 52 weeks of dosing plus the 4 week post treatment visit or has entered the long term extension study (GS-US-417-0304).
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    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: 825
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 825
    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 state59
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 533
    F.4.2.2In the whole clinical trial 1650
    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)
    All subjects who meet criteria for clinical response (per protocol), and who complete 52 weeks of study assessments will be offered an opportunity to participate in a LTE study (GS-US-417-0304). Subjects who discontinue early from the main study, or switch to standard of care treatment during the study, are not eligible for the LTE. The long term care of subjects who do not qualify or choose not to participate in the LTE will remain the responsibility of their primary treating physician.
    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 Decision2016-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-20
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