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    Summary
    EudraCT Number:2015-005285-38
    Sponsor's Protocol Code Number:IM101-591
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-01-02
    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 number2015-005285-38
    A.3Full title of the trial
    Phase II proof of concept study of Abatacept (Orencia) in individuals who aRe Considered At risk of Developing Inflammatory Arthritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ARCADIA: Phase II proof of concept study of Abatacept (Orencia) in individuals who aRe Considered At risk of Developing Inflammatory Arthritis
    A.3.2Name or abbreviated title of the trial where available
    ARCADIA
    A.4.1Sponsor's protocol code numberIM101-591
    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 SponsorThe University of Leeds
    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 organisationLeeds Teaching Hospitals Trust
    B.5.2Functional name of contact pointTracy Hulland
    B.5.3 Address:
    B.5.3.1Street AddressLeeds Institute of Rheumatic and Musculoskeletal Medicine
    B.5.3.2Town/ cityLeeds
    B.5.3.3Post codeLS7 4SA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01133924734
    B.5.6E-mailtracy.hulland@nhs.net
    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
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    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 nameOrencia
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNabatacept
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Inflammatory arthritis
    E.1.1.1Medical condition in easily understood language
    Inflammatory 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 10003246
    E.1.2Term 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 obtain preliminary evidence of the clinical efficacy of abatacept in reducing the incidence of inflammatory arthritis in individuals who are at-risk.
    E.2.2Secondary objectives of the trial
    To evaluate the ability of abatacept to influence immune, clinical and imaging biomarkers in anti-CCP positive individuals at risk of progressing to IA. To determine whether T-cell subset biomarkers are valid surrogate markers for progression to IA, and to determine if there is a response to treatment in these biomarkers.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Participant in Leeds CCP ‘Next Generation’ observational cohort who has tested positive for anti-CCP Ab in the context of a new musculoskeletal complaint.
    • Age >18 years old.
    • A moderate to high risk of progression to IA (see below)
    • Consents to be contacted in future for an interventional study


    A prediction model will be used to risk stratify individuals based on the following predictors:
    a. Tenderness of ≥1 small joint of the hands or feet (wrists, metacarpophalangeal (MCP), proximal interphalangeal (PIP), midtarsal and/or meta-tarsophalangeal joints) defined by the physician on examination.
    b. Early morning stiffness > or = 30 minutes
    c. RF and/or anti-CCP Ab concentration >3x upper limit of normal.

    The individual’s risk will be calculated according to the model suggested by Rakieh et al. (1). This gives 1 point each for presence of tenderness and EMS≥30 mins, and 2 points for rheumatoid factor or ACPA antibody >3x upper limit of normal. Participants with a score ≥3 will be considered as moderate to high risk of developing IA (≥ 40% progression risk), therefore eligible for randomisation.

    • For the intervention arm:
    o Randomised to intervention arm
    o Consents to commence Abatacept therapy (if not, will remain in CCP Next-generation study)
    • For the control arm:
    o Randomised to the control arm
    o These patients will remain in the CCP Next-generation study
    E.4Principal exclusion criteria
    1. Both Intervention arm and control arm
    • Previous diagnosis of RA or other form of inflammatory arthritis including, but not limited to SLE, psoriatic arthritis, ankylosing spondylitis, gout or pyrophosphate arthropathy and including current treatment with DMARDs or biological therapy.
    • Clinical synovitis on clinical examination by a rheumatologist.
    • Presence of concomitant illness likely to require systemic glucocorticosteroid therapy during the study, in the opinion of the investigator
    • Treatment with an intravenous, intramuscular, intrabursal or intraarticular corticosteroid within 12 weeks prior to randomization.
    • Co-morbidities requiring chronic treatment with immunosuppressive or immune modulating therapy.
    • Women in the intervention arm who get pregnant during the study will be withdrawn from treatment and followed for the duration of the pregnancy for safety purposes. All participants who get pregnant will continue to be followed up via 12-weekly visits until 96 weeks has been reached and secondary end point data collected
    • Individuals with palindromic rheumatism

    2. Intervention arm only
    • History of acute allergic reactions to biologic therapies or immunoglobulins
    • Subjects with current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurologic, or cerebral disease, whether or not related to RA and which, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study.
    • Subjects who have at any time received treatment with any investigational drug within 28 days of the first dose of study drug.
    • Subjects who test positive for Hepatitis B, C or HIV.
    • Subjects with tuberculosis (TB), including those at high risk of TB, chronic viral infections, recent serious bacterial infections, subjects receiving live vaccinations within 3 months of the anticipated first dose of study medication, or those with chronic illnesses that would, in the opinion of the investigator, put the participant at risk.
    • Subjects who currently abuse drugs or alcohol
    • Subjects with a history of cancer in the last 5 years, other than non-melanoma skin cell cancers cured by local resection or carcinoma in situ.
    • Scheduled for or anticipating joint replacement surgery
    • Men or women unwilling to use an acceptable method of contraception to avoid pregnancy for up to 14 weeks after the last dose of trial medication (acceptable method of contraception described in section 7.1.4).
    • Women of childbearing potential with positive serum or urine pregnancy test within 48 hours prior to start of investigational product. Women of child bearing potential are defined as women who have had any menstrual bleeding in the last 24 months and who have not had a hysterectomy or surgical sterilisation.
    • Evidence of active or latent bacterial or viral infection at the time of potential enrolment, including human immunodeficiency or herpes zoster virus or cytomegalovirus that resolved less than 2 months prior to enrolment.
    • Inadequate haematological, hepatic or renal function within 28 days of treatment:
    o Haemoglobin <8.5 g/dL
    o White blood cells <3000/mm3
    o Platelets <100,000/mm3
    o Serum creatinine, ALT or AST >2 times upper limit of normal
    Any other laboratory test result that, in the opinion of the study investigator, might place the participant at unacceptable risk for participation in the study
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of individuals that have developed IA at 48 weeks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 weeks
    E.5.2Secondary end point(s)
    - Joint swelling and tenderness
    - Acute phase reactant levels
    - Physician assessment of global disease activity
    - Ultrasound synovitis and erosions
    - X-ray scan measurements
    - Patient-reported measures: Early morning stiffness, Joint pain, Functional impairment, Quality of life, General health assessment, Pain, Disease activity & Fatigue
    - T-cell subset levels
    - Toxicity
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Joint swelling and tenderness, acute phase reactant levels and physician assessment of global disease activity at weeks 12, 24, 36, 48, 60, 72, 84 and 96
    - Ultrasound synovitis and erosions at weeks 24, 48, 72 and 96.
    - X-ray scan measurements at weeks 48 and 96
    - Patient-reported measures (Early morning stiffness, Joint pain, Functional impairment, Quality of life, General health assessment, Pain, Disease activity, Fatigue and Toxicity) at weeks 12, 24, 36, 48, 60, 72, 84 and 96.
    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 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 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 Yes
    E.8.1.7.1Other trial design description
    cohort randomised controlled trial design
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    standard of care
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 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 trial will be 6 months after the last data capture. This will allow sufficient time for the completion of protocol procedures, data collection and data input. The sponsor will notify the MHRA and main REC that the trial has ended and will provide them with a summary of the clinical trial report within 12 months of the end of trial.
    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 months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state58
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 58
    F.4.2.2In the whole clinical trial 58
    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)
    No arrangements will be made for continued provision of the intervention. Patients will not be able to continue treatment with abatacept after they have completed the treatment phase of the trial. Patients who complete treatment will be followed up for a further 48 weeks within the context of the trial and treated according to current standards of practice.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-21
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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