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    Summary
    EudraCT Number:2009-015957-20
    Sponsor's Protocol Code Number:ArtemisUK
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-04-20
    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 number2009-015957-20
    A.3Full title of the trial
    Abatacept Treatment in Polymyositis and Dermatomyositis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to investigate treatment with the drug abatacept in patients with polymyositis and dermatomyositis.
    A.3.2Name or abbreviated title of the trial where available
    Artemis UK
    A.4.1Sponsor's protocol code numberArtemisUK
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01315938
    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 SponsorKarolinska University Hospital
    B.1.3.4CountrySweden
    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.4.2CountrySweden
    B.4.1Name of organisation providing supportMyositis Support Group
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUK Contact: King's College London
    B.5.2Functional name of contact pointUK: King's Musculoskeletal CTU
    B.5.3 Address:
    B.5.3.1Street Address3rd Floor, Weston Education Centre, Cutcombe Road
    B.5.3.2Town/ cityDenmark Hill, London
    B.5.3.3Post codeSE5 9RJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02078485787
    B.5.5Fax number02078485202
    B.5.6E-mailkch-tr.kms-ctu@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.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.2Product code EMEA/H/C/000701
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAbatacept
    D.3.9.1CAS number 332348-12-6
    D.3.9.3Other descriptive nameOrencia (trade name)
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Polymyositis and dermatomyositis
    E.1.1.1Medical condition in easily understood language
    Chronic inflammatory disorders that affect the skeletal muscle, causing muscle weakness and low muscle endurance. The lungs, joints, muscles of the GI tract and skin are also often affected.
    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 10036102
    E.1.2Term Polymyositis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10012503
    E.1.2Term Dermatomyositis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous 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 is to investigate the clinical effectiveness of treatment with abatacept on disease activity in polymyositis and dermatomyositis patients as defined by the International Myositis Assessment and Clinical Studies (IMACS) group. (The IMACS group has developed a series of assessments which patients complete when taking part in clinical trials. The results of these assessments correlate to a disease activity score).
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study relate to further defining the clinical effectiveness of treatment with abatacept by looking at:

    1. The number of responders in the delayed start arm compared with the active treatment arm at 3 and 6 months.
    2. The change in the individual components of the IMACS core set measures for disease activity in the delayed start arm compared with the active treatment arm at 3 and 6 months.
    3. The change in muscle endurance as tested by the myositis functional index (FI-2) in the delayed start arm compared with the active treatment arm at 3 and 6 months.
    4. Time to improvement of disease measured from baseline, compared between the delayed onset arm with the active treatment arm.
    5. The clinical effectiveness of abatacept after 6 months on:
    - The individual components of the IMACS core set measures for disease activity
    - Muscle strengh as tested by the myositis functional index (FI-2)
    - Health related quality of life assessed by SF-36

    The stud
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with definite or probable polymyositis or dermatomyositis dignosed according to the diagnostic criteria by Bohan and Peter (30,31).
    2. For patients with polymyositis, a muscle biopsy is required (performed at any time before the start of the study) to confirm the disease and to exclude other conditions (unless a patient is positive for myositis specific or associated autoantibodies).
    3. Polymyositis patients will be included only after agreement by the three Principal Investigators.
    4. Inflammatory active disease based on persisting or worsening muscle weakness, MMT ≤ 150 or low endurance, FI-2 ≤ 20% of upper value together with at least one other sign of active disease: elevated serum levels of muscle enzymes (CK, LD, ASAT, ALAT, above upper limit and being explained by muscle involvement and not eg. liver disease), inflammation in recent muscle biopsy (≤3 months) or on MRI scans or active extramuscular disease: skin rash, arthritis or interstitial; lung disease (ILD) (as suggested by chest X-ray, high resolution computerised tomography (HRCT), or pulmonary function test).
    5. Persisting disease activity after a minimum of 3 months treatment with prednisolone or equal drug. The treatment with prednisolone (or equal) should include the dose of at least 0.75 mg/kg/day for at least 1 month in the history and should be stable 1 month prior the baseline visit. Maximum dose of glucocorticoids should not exceed the equivalent of Prednisone 30 mg per day at the time of randomisation.
    6. Combination with at least one other immunosuppressive drug, which includes methotrexate (minimum dose 15 mg/week) or azathioprine (minimum dose 100 mg/day) for at least 3 months. The dose of methotrexate or azathioprine should be stable for at least 1 month before the first administration of abatacept.
    7. If methotrexate or azathioprine has had to be stopped or the dose decreased due to documented intolerance, lower dose or absence of these drugs is accepted provided this situation is stable for 1 month before the baseline.
    8. Age between 18 - 80 years.
    9. Signed informed consent.
    E.4Principal exclusion criteria
    1. Patients with other types of inflammatory myopathies including:
    - Drug induced myositis.
    - Inclusion body myositis
    - Malignancy associated myositis
    2. Women who are pregnant or breastfeeding.
    3. Women with a positive pregnancy test on enrolment or prior to start of study drug administration.
    4. Women of child bearing age who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for 10 weeks after the last infusion of study medication.
    5. Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, ophthalmologic or cerebral disease with the exception of those symptoms that are a manifestation of polymyositis or dermatomyositis. Concomitant medical conditions that in the opinion of the investigator might place the subject at unacceptable risk for participation in this study.
    6. Subjects with a history of cancer within the last five years (other than non-melanoma skin cell cancers cured by local resection). Existing non-melanoma skin cell cancers must be removed prior to dosing. Patients with dermatomyositis need to be screened for malignancies according to routine procedures.
    7. Subjects who have a history of clinically significant drug or alcohol abuse. Subjects currently taking methotrexate who admit to consumption of more than an average of 1 alcoholic drink per day.
    8. Subjects with any serious bacterial infection (such as pneumonia, other renal infection and sinusitis), unless treated and resolved with antibiotics or chronic bacterial infection (such as pyelonephritis and chest infection with bronchiectasis) in the previous 3 months.
    9. Subjects with active tuberculosis requiring treatment within the previous 3 years. Subjects with a positive PPD at screening will not be eligible for the study unless they completed treatment for latent TB and have a negative chest x-ray at enrolment. A PPD response that is equal to or greater than 10 mm should be considered a positive test, although more conservative criteria may be applied as determined by the clinical circumstance and investigator according to published guidelines and/or local standards endorsed by the medical society. Quantiferon assay may replace PPD testing and patients are excluded from the study if the test is positive. Quantiferon positive patients who completed treatment for latent tuberculosis according to the local guidelines may be considered for enrolment.
    10. Subjects with herpes zoster that resolved less than 2 months prior to enrolment.
    11. Subjects with evidence (as assessed by the Investigator) of active or latent bacterial or viral infections at the time of potential enrolment, including subjects with evidence of Human Immunodeficiency Virus (HIV) infection.
    12. Significant toxicities associated with concomitant or previous immunosuppressive
    therapy and anti-TNF therapy that would preclude subjects from participating and completing the study.
    13. Patients with clinically apparent immunodeficiency syndrome, (IgA deficiency alone is not an exclusion criterion)
    14. Subjects with any of the following laboratory values:
    • Hgb < 8.5 g/dL.
    • WBC < 3,000/mm3 (3 x 109/L).
    • Platelets < 100,000/mm3 (100 x 109/L).
    • Serum creatinine > 2 times upper limit of normal.
    • Any other laboratory test results that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study.
    15. Subjects previously treated with rituximab: B cell levels are less than lower limit of normal as measured by Fluorescent Activated Cell Sorting (FACS) analysis.
    16. For all patients who have received prior rituximab, a normal CD19B cell count must be documented at the time of screening for this study.
    17. Patients with Large Granular Lymphocyte (LGL) syndrome (to minimise the risk of including patients with high frequency of CD28 null T cells) that may not benefit from treatment.

    Prohibited Therapies and/or Medications:
    18. Subjects who have at any time received treatment with BMS-188667, CTLA4Ig or.
    abatacept.
    19. Subjects who have received treatment with any investigational drug within 28 days of the Day 1 dose.
    20. For subjects currently receiving treatment with mycophenolate mofetil (CellCept), cyclosporine, cyclophosphamide, tacrolimus, leflunomide, anakinra, d-penicillamine or calcineurin inhibitors, a washout period of one month is required.
    E.5 End points
    E.5.1Primary end point(s)
    The number of responders, defined as improved according to the International Myositis Assessment and Clinical Studies Group (IMACS) criteria after treatment with abatacept after six months.

    The definition of improvement is based on the following core set of clinical and laboratory variables to assess disease activity:

    1) Physician global disease activity assessment by Likert or VAS (0-100)
    2) Patient global disease activity assessment by Likert or VAS (0-100)
    3) Manual muscle test (MMT) in 8 muscles on the dominant side, by a 0-10 point scale including proximal, distal and axial muscles , maximum score 150 for bilateral testing
    4) Validated patient questionnaire of activities of daily living (HAQ)
    5) At least two serum muscle enzyme activities from the following: creatine kinase (CK), aldolase, lactate dehydrogenase (LDH), alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
    6) Extramuscular score Myositis Disease Activity Assessment Tool (MDAAT) or MYOACT that includes general, cutaneous, gastrointestinal, articular, cardiac and pulmonary disease activity related to the myositis

    Any 3 of 6 core set measures improved ≥ 20% with no more than 2 (not including manual muscle test (MMT)) worse by ≥ 25%.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be evaluated at 6 months.
    E.5.2Secondary end point(s)
    1.The number of responders in the delayed onset arm compared with the active treatment arm at 3 and 6 months.
    2.Improvement in each of the individual components of core set measures by 20%
    3.Muscle endurance as tested by the myositis functional index (FI-2) improved by 20%
    4.Improved quality of life by SF-36
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints will be evaluated at 3 and 6 months.
    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 Yes
    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
    To investigate the role of T cells in disease mechanisms in polymyositis and dermatomysitis
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 EEA3
    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 last follow up study visit of the last participant.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number 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: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Polymyositis and dermatomyositis are incurable diseases which classifies these patients as vunerable
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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 will be informed at screening that they will have to return to NHS standard care once the study is complete. However, if a patient is responding particularly well to abatacept treatment, an application will be made to the PCT for the patient to continue on this treatment.
    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 Decision2012-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-11-28
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