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    The EU Clinical Trials Register currently displays   35896   clinical trials with a EudraCT protocol, of which   5892   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-003413-18
    Sponsor's Protocol Code Number:IM101
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-04-04
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-003413-18
    A.3Full title of the trial
    Arthritis Prevention In the Pre-clinical Phase of RA with Abatacept.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Arthritis prevention with abatacept
    A.3.2Name or abbreviated title of the trial where available
    APIPPRA
    A.4.1Sponsor's protocol code numberIM101
    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 SponsorKing’s College London
    B.1.3.4CountryUnited Kingdom
    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 supportBristol-Myers Squibb
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Department of Rheumatology
    B.5.2Functional name of contact pointAndrew P. Cope, Chief Investigator
    B.5.3 Address:
    B.5.3.1Street Address1st Floor New Hunt’s House, Great Maze Pond, Guy’s Campus
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 1UL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00440207848 6901
    B.5.5Fax number00440207848 8632
    B.5.6E-mailandrew.cope@kcl.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorGuy's and St. Thomas' NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportBristol-Myers Squibb
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Department of Rheumatology
    B.5.2Functional name of contact pointAndrew P. Cope, Chief Investigator
    B.5.3 Address:
    B.5.3.1Street Address1st Floor New Hunt’s House, Great Maze Pond, Guy’s Campus
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 1UL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00440207848 6901
    B.5.5Fax number00440207848 8632
    B.5.6E-mailandrew.cope@kcl.ac.uk
    B.Sponsor: 3
    B.1.1Name of SponsorLeiden University Medical Center
    B.1.3.4CountryNetherlands
    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 supportBristol-Myers Squibb
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Department of Rheumatology
    B.5.2Functional name of contact pointAndrew P. Cope, Chief Investigator
    B.5.3 Address:
    B.5.3.1Street Address1st Floor New Hunt’s House, Great Maze Pond, Guy’s Campus
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 1UL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00440207848 6901
    B.5.5Fax number00440207848 8632
    B.5.6E-mailandrew.cope@kcl.ac.uk
    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 ORENCIA 125 mg solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Solution for infusion in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 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 infusion in pre-filled syringe
    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
    The target population for therapeutic intervention will be subjects who carry serum autoantibodies (antibodies to citrullinated protein antigens – ACPA; rheumatoid factor – RF) and who have joint pains (arthralgia) but no joint swelling. These subjects are deemed to be at highest risk of developing rheumatoid arthritis.
    E.1.1.1Medical condition in easily understood language
    The preclinical phase of RA. During this phase individuals are experiencing joint pains, but have not yet developed arthritis (clinically apparent joint swelling).
    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 10003239
    E.1.2Term Arthralgia
    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 feasibility, efficacy and acceptability of abatacept therapy in subjects at high risk of developing RA.
    E.2.2Secondary objectives of the trial
    To characterise immune and inflammatory responses associated with ACPA before, during and after therapy with abatacept.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female subjects, aged ≥ 18 years.
    - Arthralgia that is considered to be inflammatory in nature.
    - ACPA and RF positive, or high titre ACPA.
    - Able and willing to give written informed consent and comply with the requirements of the study protocol.
    E.4Principal exclusion criteria
    - Clinically apparent arthritis, as assessed by a rheumatologist.
    - A history of inflammatory arthritis, as assessed by a rheumatologist.
    - History or current use of DMARDs or biologics.
    - History of oral or parenteral use of corticosteroids within the last 12 weeks.
    - Co-morbidities requiring treatment with immunosuppressive or immune modulating therapy.
    - Chronic illnesses that would, in the opinion of the investigator, put the subject at risk.
    - Recipients of a live vaccine within 3 months of inclusion.
    - Pregnant or breastfeeding
    - Unable to give informed consent
    E.5 End points
    E.5.1Primary end point(s)
    1) The time to development of clinically apparent synovitis in ≥ 3 joints, as determined by two independent assessors with experience in clinical assessment of RA
    2) The time to development of RA according to the ACR/EULAR 2010 criteria, where joint involvement is defined as joint swelling.
    In either case joint swelling will be confirmed by ultrasound.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 3 months for up to 24 months
    E.5.2Secondary end point(s)
    1) The development of RA according to the ACR/EULAR 2010 criteria where ultrasound
    2) Assessments of disease activity and progression over time, using DAS28 (tender and swollen joint counts, patient global visual analogue score (VAS), ESR) and Extended Joint Count 68/66, Simple Disease Activity Score (SDAI) and Clinical Disease Activity Score (CDAI), Pain VAS, Lifestyle Factors Questionnaire, Health Assessment Questionnaire (HAQ), Modified Illness Perception Questionnaire (Modified IPQ-R), Euro-Quality of Life Questionnaire (EQ-5D), Hospital Anxiety and Depression Scale (HADS), Work Instability Scale (RA-WIS), Functional Assessment Of Chronic Illness Therapy-Fatigue (FACIT-F) and Symptoms in Persons At Risk of Rheumatoid Arthritis (SPARRA) questionnaire.
    3) The proportion of participants requiring DMARD therapy, and the time to commencing DMARD therapy, including oral or parenteral corticosteroids.
    4) Progression of radiographic changes in X-rays of the hands and feet scored by van der Heijde Sharpe Modified Scores or using the Larsen score.
    5) Changes in scores of synovitis and vascularity defined by high resolution ultrasonography and power Doppler over time.
    6) Adverse events.

    The exploratory endpoints of this study are:
    1) Changes in serum ACPA levels over time.
    2) ACPA isotype and antigenic fine specificity over time.
    3) Signatures of immune and inflammatory responses as defined through analysis of serum, peripheral blood cell subsets, peripheral blood RNA expression profiling and urine.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will be evaluated every 3 months for up to 24 months

    The exploratory endpoints will be evaluated at the end of the study following analysis of the biological samples.
    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
    Prevention
    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.8.2.4Number of treatment arms in the trial2
    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 concerned28
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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 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 study is defined as last subject's last assessment(at 24 months).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months3
    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: 206
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 206
    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 state186
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 206
    F.4.2.2In the whole clinical trial 206
    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)
    Subjects who meet the primary end point during the study will be offered standard therapy for the treatment of inflammatory arthritis, according to guidelines. Subjects whose RA is not adequately controlled by standard DMARDs may then be eligible for biological therapy, such as a TNFinhibitor. Subjects who do not meet the endpoint/not develop arthritis, will be offered long term follow up from their local rheumatology department in consultation with their rheumatologist.
    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 Decision2014-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-03
    P. End of Trial
    P.End of Trial StatusOngoing
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