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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2010-022207-22
    Sponsor's Protocol Code Number:H9B-MC-BCDV
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-04-11
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2010-022207-22
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-α Inhibitors (FLEX-V)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study in Patients With Rheumatoid Arthritis(FLEX-V)
    A.4.1Sponsor's protocol code numberH9B-MC-BCDV
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01202773
    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 SponsorEli Lilly and Company
    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 supportEli Lilly and Company
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly and Company
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Addressn/a
    B.5.3.2Town/ cityn/a
    B.5.3.3Post coden/a
    B.5.3.4CountryEuropean Union
    B.5.4Telephone numbern/a
    B.5.5Fax numbern/a
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 nameLY2127399
    D.3.2Product code LY2127399
    D.3.4Pharmaceutical form Solution for 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 INNn/a
    D.3.9.1CAS number n/a
    D.3.9.2Current sponsor codeLY2127399
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 typeIgG4-variant monoclonal antibody
    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 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 nameLY2127399
    D.3.2Product code LY2127399
    D.3.4Pharmaceutical form Solution for 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 INNn/a
    D.3.9.1CAS number n/a
    D.3.9.2Current sponsor codeLY2127399
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 typeIgG4-variant 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 placeboSolution for injection
    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
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to demonstrate, in patients with an inadequate response to one or more TNF alpha (TNF-α) inhibitors, the superiority of 120 mg LY2127399 every 4 weeks (Q4W) (LY A) or 90 mg LY2127399 every 2 weeks (Q2W) (LY B), each after a loading dose, compared to placebo as measured by the American College of Rheumatology 20% response rates (ACR20) over 24 weeks.
    E.2.2Secondary objectives of the trial
    • To demonstrate, in patients with an inadequate response to one or more TNF α inhibitors, the superiority of LY A or LY B compared to placebo over 24 weeks, as assessed by the:
     ACR 50% response rate (ACR50), ACR 70% response rates (ACR70), and ACR percent improvement (ACR-N) indices
     Individual components of the ACR Core Set
     Disease Activity Score based on a 28 joint count (DAS28) and C-reactive protein level (CRP) (DAS28-CRP)
     European League Against Rheumatism Responder Index based on the 28 joint count (EULAR-28)
     Health outcome measures: Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), Brief Fatigue Inventory (BFI), Brief Pain Inventory Modified Short Form (BPI-sf modified), and duration of morning stiffness.
     Time to ACR20 response
    • To evaluate the safety and tolerability of LY A or LY B compared with placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients will be male and female aged ≥18 years of age with a diagnosis of moderately to severely active adult onset RA
    • Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years
    • At least 8 tender and swollen joints
    • An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate (ESR)
    • Positive for Rheumatoid Factor (RF) or Anti-cyclic citrullinated peptide (CCP) antibody
    • Previously treated with biologic TNF-α inhibitor therapy (infliximab, certolizumab, golimumab, etanercept, adalimumab) and stopped treatment due to insufficient efficacy or intolerance
    • Regular use of at least one conventional disease-modifying anti-rheumatic drug (DMARD), with a stable dose for at least 8 weeks prior to study start
    • Woman must not be pregnant, breastfeeding, or become pregnant during the study
    E.4Principal exclusion criteria
    • Use of unstable doses of non-steroidal inflammatory drugs (NSAIDS) in the past 6 weeks
    • Steroid injection or intravenous (IV) infusion in the last 6 weeks
    • Use of more than 10 mg/day of oral steroids in the last 6 weeks
    • History of a serious reaction to other biological DMARDs
    • Use of an oral calcineurin inhibitor (e.g., cyclosporin or tacrolimus) in the last 8 weeks
    • Surgery on a joint or other major surgery less than 2 months ago, or plans to have joint surgery or major surgery during the study
    • Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition except RA
    • Cervical cancer or squamous skin cancer within the past 3 years, or other cancer within the past 5 years
    • Received a live vaccine received within the past 12 weeks (for example, vaccines for measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines)
    • Hepatitis or human immunodeficiency virus (HIV)
    • A serious bacterial infection (for example, pneumonia or cellulitis) within 3 months or a serious bone or joint infection within 6 months
    • Symptoms of herpes zoster or herpes simplex within the last month
    • Active or latent tuberculosis (TB)
    • Current symptoms of a serious disorder or illness
    • Use of an investigational drug within the last month
    E.5 End points
    E.5.1Primary end point(s)
    • Percentage of patients with American College of Rheumatology 20% response (ACR20)
    • Percentage of patients with American College of Rheumatology 50% (ACR50) and 70% (ACR70) response
    • Mean percent improvement in ACR-N
    • Change from baseline to 24 weeks in Tender Joint Count (68 joint count)
    • Change from baseline to 24 weeks in Swollen Joint Count (66 joint count)
    • Change from baseline to 24 weeks in Patient's Assessment of Pain (VAS)
    • Change from baseline to 24 weeks in Patient's Global Assessment of Disease Activity (VAS)
    • Change from baseline to 24 weeks in Physician's Global Assessment of Disease Activity (VAS)
    • Change from baseline to 24 weeks in Health Assessment Questionnaire-Disability Index (HAQ-DI)
    • Change from baseline to 24 weeks in Disease Activity Score-C-Reactive Protein (DAS28-CRP)
    • Percentage of patients with DAS28-Based European League Against Rheumatism (EULAR) response
    • Change from baseline to 24 weeks in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) domain and summary scores
    • Change from baseline to 24 weeks in Brief Fatigue Inventory (BFI) individual items and impact scores
    • Change from baseline to 24 weeks in Brief Pain Inventory Short Form (BPI-sf) individual items and interference scores
    • Change from baseline to 24 weeks in duration of morning stiffness (minutes)
    • Time to ACR20 response
    • Change from baseline to 24 weeks in absolute B cell counts
    • Change from baseline to 24 weeks in serum immunoglobulin (Ig) levels
    • Population Pharmacokinetics (PK)
    • Percentage of patients developing anti-LY2127399 antibodies
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    E.5.2Secondary end point(s)
    •Percentage of patients with American College of Rheumatology 50% (ACR50) and 70% (ACR70) response
    •Mean percent improvement in ACR-N
    •Change from baseline to 24 weeks in Tender Joint Count (68 joint count)
    •Change from baseline to 24 weeks in Swollen Joint Count (66 joint count)
    •Change from baseline to 24 weeks in Patient's Assessment of Pain (VAS)
    •Change from baseline to 24 weeks in Patient's Global Assessment of Disease Activity (VAS)
    •Change from baseline to 24 weeks in Physician's Global Assessment of Disease Activity (VAS)
    •Change from baseline to 24 weeks in Health Assessment Questionnaire-Disability Index (HAQ-DI)
    •Change from baseline to 24 weeks in Disease Activity Score-C-Reactive Protein (DAS28-CRP)
    •Percentage of patients with DAS28-Based European League Against Rheumatism (EULAR) response
    •Change from baseline to 24 weeks in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) domain and summary scores
    •Change from baseline to 24 weeks in Brief Fatigue Inventory (BFI) individual items and impact scores
    •Change from baseline to 24 weeks in Brief Pain Inventory Short Form (BPI-sf) individual items and interference scores
    •Change from baseline to 24 weeks in duration of morning stiffness (minutes)
    •Time to ACR20 response
    •Change from baseline to 24 weeks in absolute B cell counts
    •Change from baseline to 24 weeks in serum immunoglobulin (Ig) levels
    •Population Pharmacokinetics (PK)
    •Percentage of patients developing anti-LY2127399 antibodies
    •Change from baseline to 24 weeks in CRP
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks
    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 Yes
    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) 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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
    Brazil
    Colombia
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    New Zealand
    Russian Federation
    Taiwan
    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
    As per protocol
    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 months8
    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 months5
    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: 497
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 158
    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 state103
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 383
    F.4.2.2In the whole clinical trial 555
    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 who complete this study through to Week 24 may be eligible to continue receiving study drug in an open label extension study, protocol H9B-MC-BCDP.
    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 Decision2011-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-01-06
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