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    Summary
    EudraCT Number:2016-000498-19
    Sponsor's Protocol Code Number:GA30067
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-08-19
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2016-000498-19
    A.3Full title of the trial
    A PHASE II OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA29350 TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Patients Previously Enrolled in Study GA29350 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Rheumatoid Arthritis
    A.4.1Sponsor's protocol code numberGA30067
    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 SponsorGenentech, 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 supportGenentech Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameGDC-0853
    D.3.2Product code RO7010939
    D.3.4Pharmaceutical form 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 INNnot available
    D.3.9.3Other descriptive nameGDC-0853 RO7010939
    D.3.9.4EV Substance CodeSUB181260
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 (RA) is a form of arthritis that causes pain, swelling, stiffness, and loss of function in your joints
    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 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
    • To evaluate the long-term safety of GDC-0853 over an extended treatment period of up to 52 weeks
    • To evaluate the efficacy of GDC-0853 (analysed separately for methotrexate-inadequate response [MTX-IR] and tumour necrosis factor-inadequate response [TNF-IR] patients) at Week 52 relative to baseline in Study GA29350
    E.2.2Secondary objectives of the trial
    • To determine the improvement in disease activity through 52 weeks of treatment (analysed separately for MTX-IR and TNF-IR patients) relative to baseline in Study GA29350
    • To assess Disease Activity Score (DAS28) remission (< 2.6) and Low-disease activity [LDA] (< 3.2) state
    • To assess American College of Rheumatology (ACR)/European League
    Against Rheumatism (EULAR) remission according to the Boolean-based
    definition
    • To assess simplified disease activity index (SDAI)-based remission (ACR/EULAR remission) and clinical disease activity index (CDAI)-based remission
    • To assess efficacy based on the individual components of theACR relative to baseline in Study GA29350
    • To evaluate the effect of GDC-0853 on health-related quality of life and on fatigue
    • To characterize the pharmacokinetics (PK) of GDC-0853 in patients using a population PK approach
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18 to 76
    - Completion of treatment period through Day 84 as specified in Study
    GA29350
    - Acceptable safety and tolerability during Study GA29350 as determined by the investigator or Medical Monitor
    - Have not received any prohibited medications in Study GA29350
    - While taking MTX, must be willing to receive oral folic acid (at least 5 milligram [mg]/week)
    E.4Principal exclusion criteria
    - Met protocol defined treatment stopping criteria during Study GA29350
    - Treatment with any investigational agent (other than study drug) or live/attenuated vaccine during Study GA29350 or since the last administration of study drug in Study GA29350
    - In the opinion of the investigator, any new (since initially enrolling in the Phase II Study GA29350), significant, uncontrolled comorbidity, such as neurological, cardiac (e.g., moderate to severe heart failure New York Heart Association [NYHA] Class III/IV), pulmonary, renal, hepatic, endocrine, or GI disorders (excluding RA) that would increase the risk to the patient in Study GA30067
    - Pregnant or lactating, or intending to become pregnant during the study
    - Any uncontrolled or clinically significant laboratory abnormality that would affect safety, interpretation of study data, or the patient’s participation in the study in the opinion of the investigator
    - Patients who experienced a de novo or reactivated serious viral infection such as hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV during the Phase II Study GA29350
    E.5 End points
    E.5.1Primary end point(s)
    Safety:
    1. Incidence of adverse events
    2. Changes in vital signs, physical findings, ECGs, and clinical laboratory results during and following GDC-0853 administration

    Efficacy:
    3. ACR50 response at Week 52
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety:
    1-2. Up to 60 weeks
    Efficacy:
    3. Week 52
    E.5.2Secondary end point(s)
    Efficacy:
    1. ACR50 response up to Week 12
    2. ACR20 and ACR70
    3. Disease Activity Score (DAS) 28-3 C-reactive protein (CRP) and DAS 28-4 (CRP) responder rates
    4. DAS 28-3 (Erythrocyte Sedimentation Rate [ESR]) and DAS 28-4 (ESR) responder rates
    5. DAS28 remission (< 2.6) and LDA (< 3.2) state
    6. Boolean based remission
    7. Simplified disease activity index-based remission
    8. Clinical disease activity index-based remission status
    9. Response rates for tender/painful joint count (68) and swollen joint count (66)
    10. Patient’s Assessment of Arthritis Pain
    11. Patient’s Global Assessment of Arthritis
    12. Physician’s Global Assessment of Arthritis
    13. CRP
    14. Health assessment questionnaire–Disability Index
    15. Short-Form 36 Health Survey, standard, Version 2, questionnaire
    16. Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale

    PK:
    17. Area under the concentration time-curve from time 0 to time t (AUC0-t)
    18. Minimum observed plasma concentration (Ctrough)
    19. Half-life, apparent (t1/2)
    20. Clearance following oral dosing (CL/F)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy:
    1. Up to Week 12
    2-16. Up to Week 52

    PK:
    17-20. Day (D) 1, D84, D365 and early termination or an unscheduled visit
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open 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.8.3 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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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
    Brazil
    Bulgaria
    Chile
    Colombia
    Korea, Republic of
    Mexico
    Poland
    Russian Federation
    Serbia
    Ukraine
    United States
    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
    The end of this study is defined as the date when the last patient, last visit (LPLV) occurs or the date at which the last data point required for statistical analysis or safety follow-up is received from the last patient, whichever occurs later. LPLV is expected to occur approximately 60 weeks after the last patient is enrolled.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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: 430
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 243
    F.4.2.2In the whole clinical trial 580
    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)
    Currently, the Sponsor (Genentech, a member of the Roche Group) does not have any plans to provide GDC-0853 or any other study treatments or interventions to patients who have completed Study GA30067. The Sponsor may evaluate whether to continue providing GDC-0853 in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, available at the following Web site:
    http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    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 Decision2016-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-07-17
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