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    Summary
    EudraCT Number:2006-003698-29
    Sponsor's Protocol Code Number:20060119
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-09-04
    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 ConcernedLatvia - SAM
    A.2EudraCT number2006-003698-29
    A.3Full title of the trial
    A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis
    A.4.1Sponsor's protocol code number20060119
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAmgen 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameAMG 108
    D.3.2Product code AMG 108
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeAMG 108
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    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 (RA)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    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 for this study is to assess long-term safety of AMG 108 (125mg, 250 mg) SC in subjects with RA previously enrolled in study 20050168
    E.2.2Secondary objectives of the trial
    • To assess impact of concomitant immunosuppressives on long- term safety profile of AMG 108
    • To assess impact of comorbidity on adverse event ( AE) profile of AMG 108
    • To determine whether long- term use of AMG 108 improves function in subjects with RA
    • To assess the change in mental and physical component summaries (MCS & PCS) and each of the 8 domain scores of SF- 36 from baseline to weeks 24, 48, 96, 144 and EOS
    • To determine effect of long- term use of AMG 108 on work productivity
    • To evaluate long- term pharmacokinetics ( trough levels) of AMG 108
    • To assess the clinical effect of AMG 108 as determined by ACR20 response at week 24, 48, 96, 144 and EOS
    • To determine whether immunogenicity of AMG 108 affects efficacy and safety as determined by frequency, subject incidence and time- to- onset of cardiovascular safety events and changes in biomarkers related to cardiovascular disease
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Major inclusion criteria are:
    • Subjects must have met all inclusion criteria and none of the exclusion criteria for study 20050168, were randomized and completed 24 weeks of the study.
    • Subjects must receive their first dose of IP within 18 days from their Week 24 visit in study 20050168.
    • Signed informed consent
    E.4Principal exclusion criteria
    Major exclusion criteria are:
    • Uncontrolled or Significant concurrent medical events, in the opinion of the investigator, including:
    - Asthma
    - Malignancy
    - Liver disease
    - Renal disease
    - Hematologic abnormality
    - Diabetes mellitus
    - Cardiovascular disease
    - Hypertension
    - Chronic inflammatory disease or connective disease other than RA or secondary Sjogren’s syndrome
    - Infections (CTC grade 3) lasting > 2 consecutive weeks and/ or not responding to treatment in study 20050168
    • Pregnant or nursing
    • Sexually active subjects and their partners who are of childbearing potential (ie, neither surgically sterile nor postmenopausal) and not using adequate contraception
    • Any physical and/or psychiatric condition that, in the opinion of the investigator, compromises the ability of the subject to give written informed consent
    • Any condition or disorder that, in the opinion of the investigator, would interfere with compliance with study procedures
    • Active substance abuse
    • Requiring or having a condition that, in the opinion of the investigator, may be expected to require strong narcotic analgesics (except hydrocodone, codeine, dextropropoxyphene, propoxyphene, or oxycodone) or morphine derived medication for analgesic relief at screening
    • Inability or unwillingness to self- administer (or by designated person) subcutaneous injections at home
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints are:
    • AE
    • Serious Adverse Event (SAE)
    • Serious infectious event (SIE)
    • Infectious event (IE)
    • Injection site reaction (ISR)
    • Change (by Common Toxicity Criteria grade) from baseline laboratory values
    • Infections in subjects with neutrophil counts <1.5 x 10’/pL
    • Opportunistic infections
    • Malignant neoplasm
    • Anti-AMG 108 antibodies (by immunoassay and cell-based bioassay)

    The secondary endpoints are:·
    • Change in mental and physical component summary ( MCS & PCS) of SF- 36 from baseline to weeks 24, 48, 96, 144 and End of Study
    • Change in HAQ- DI score from baseline to weeks 24, 48, 96, 144 and EOS
    • Change in EQ- 5D from baseline to weeks 24, 48 96, 144 and EOS
    • Change in work productivity measured by Work Productivity and Activity Impairment ( WPAI) Questionnaire from baseline to weeks 24, 48, 96, 144 and EOS
    • ACR20 response at week 24, 48, 96, 144 and EOS
    • ACR20 responses in subjects who are positive at least once or negative for anti- AMG 108 antibodies on both immunoassay and cell- based bioassay
    • AMG 108 trough concentration ( Cmin) at week 48, 96 and 144

    The exploratory endpoints include the following:
    • ACR50 and ACR70 response at week 24, 48, 96, 144 and EOS
    • ACRn at week 24, 48, 96, 144 and EOS
    • AUC ACRn at week 24, 48, 96, 144 and EOS
    • Individual components of ACR response ( 20, 50 and 70) at week 24, 48, 96, 144 and EOS
    • DAS score and change in DAS 28 score from baseline ( EULAR28 response) at week 24, 48, 96, 144 and EOS
    • Time to onset of cardiovascular event from baseline
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 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.8.3 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA76
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The end of the study is defined as the last visit of the last subject off the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-09-04. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 593
    F.4.2.2In the whole clinical trial 784
    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)
    Normal treatment
    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 Decision2007-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-03-19
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