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    Summary
    EudraCT Number:2008-004878-41
    Sponsor's Protocol Code Number:RR08-8686
    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:2009-09-24
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-004878-41
    A.3Full title of the trial
    ASUS: Abatacept in Seronegative Undifferentiated arthritis Study
    Prospective, Single-centre, Pilot Study Assessing the Efficacy of Abatacept in Anti-CCP Negative Undifferentiated Inflammatory Arthritis
    A.3.2Name or abbreviated title of the trial where available
    ASUS
    A.4.1Sponsor's protocol code numberRR08-8686
    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 SponsorUniversity 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 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 Yes
    D.2.1.1.1Trade name Orencia
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Company
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameAbatacept (IV)
    D.3.2Product code BMS-188667
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.2Current sponsor codeBMS-188667
    D.3.9.3Other descriptive nameCTLA4Ig
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Yes
    D.3.11.13.1Other medicinal product typeFusion protein
    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
    Undifferentiated Arthritis
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the proportion of subjects with CCP-negative, power Doppler positive Undifferentiated Arthritis who on open-label Abatacept medication achieve the following criteria at 6 months:
    1. DAS44 remission i.e. DAS44-CRP < 1.6
    2. Maximum of one swollen joint for at least 3 consecutive months
    3. No radiographic progression defined as change that does not exceed the
    smallest detectable change over one year
    E.2.2Secondary objectives of the trial
    1) Assess proportion of subjects:
    Achieve DAS44 remission
    Achieve DAS28 remission
    Achieve modified ACR remission (mACRR)
    With persistent symptomatic clinical synovitis

    2) Assess disease activity over time

    3) Assess degree of synovitis using power Doppler US imaging; assess structural joint damage with plain radiography of the hands using Genant-modified Sharp Score; and bone densitometry.

    4) Assess physical function and health-related quality of life using SF-36 and Disability Index of HAQ, respectively as well as EQ-5D health outcome and quality of life assessment using RAQoL

    5) Determine steroid need for duration of the study

    6) Record proportion of patients that progress to RA (or any other autoimmune disease)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ASUS: Biological Sub-Study
    Exploratory Objective = To evaluate change in immunological parameters at weeks -4, 12, 24, 36 and 48 (as part of a biological sub-study)
    E.3Principal inclusion criteria
    Subjects must have a diagnosis of UA defined as:
    - A subject with symptomatic clinical synovitis of two or more joints.
    - Subjects must not meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematous).
    - The subject’s disease duration [defined as the time from the onset of symptoms (joint pain, swelling, or stiffness) of arthritis to enrollment must be > 12 weeks and < one year.
    - Power Doppler positive signal of >/= 1 (10 patients with PD = 1; 10 patients with PD >/= 2)
    - Subjects must be negative for autoantibodies against cyclic citrullinated peptides by ELISA and rheumatoid factor.
    - No prior therapy with DMARD or biologic therapy.

    Age and Gender
    - Men and women, ages 18 - 75 years old.
    - Men and Women of childbearing potential are eligible if they are practicing effective contraceptive measures.
    - Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 10 weeks after the last infusion of Abatacept in such a manner that the risk of pregnancy is minimised.
    - WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea ≥ 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35mIU/mL].
    - Women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential.
    - WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 48 hours prior to the start of study medication
    - Male subjects must be using an adequate method of contraception throughout the study including up to 10 weeks after the last infusion of Abatacept so that the risk of pregnancy to their partner is minimised.
    E.4Principal exclusion criteria
    Women and Reproductive Status
    - WOCBP who are unwilling or unable to adhere to an acceptable form of contraception throughout the period of the study timetable and for up to 10 weeks after the last infusion of Abatacept
    - Women who are pregnant or breastfeeding
    - Women with a positive pregnancy test on enrollment or prior to study drug administration
    - Males unwilling or unable to use an adequate method of contraception for the entire study period and for up to 10 weeks after the last infusion of study medication.

    Medical History and Concurrent Diseases
    - Subjects who are impaired, incapacitated, or incapable of completing study related assessments.
    - Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematous).
    - UA duration of greater than one year
    - Subjects who have previously received treatment with a DMARD or an approved biologic RA therapy (infliximab, etanercept, anakinra, adalimumab).
    - Subjects who have received ≥ 1 steroid injection (IM/IA) within 6 week period prior to baseline
    - Subjects with active vasculitis of a major organ system.
    - Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease.
    - Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study.
    - 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.
    - Subjects with any serious acute bacterial infection (such as pneumonia or pyelonephritis unless treated and completely resolved with antibiotics).
    - Subjects with severe chronic or recurrent bacterial infections (such as recurrent pneumonia, chronic bronchiectasis).
    - Subjects with active tuberculosis (TB) requiring treatment within the previous years.
    - Subjects with a positive mantoux test at screening will not be eligible for the study unless active TB infection has been ruled out. A mantoux test response that is equal to or greater than 10 mm should be considered a positive test, although a lower threshold (5 mm) may be applied as determined by the clinical circumstance and investigator according to published guidelines and/or local standards endorsed by the medical society.


    Physical and Laboratory Test Findings
    - Hepatitis B surface antigen-positive subjects.
    - Hepatitis C antibody-positive subjects who are also RIBA-positive or PCR-positive.
    - Subjects with any of the following laboratory values:
    o Haemoglobin < 8.5 g/dL.
    o WBC < 3,000/mm3 (3 x 109/L)
    o Platelets < 100,000/mm3 (100 x 109/L).
    o Serum creatinine > 2 times upper limit of normal.
    o Serum ALT or AST > 2 times upper limit of normal.
    o Any other laboratory test results that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study.

    Prohibited Therapies and/or Medications
    - Prior treatment with any DMARD or biological therapy before screening.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints of this study will therefore be the following at 6 months:
    1. DAS44 remission i.e. DAS44-CRP < 1.6
    2. Maximum of one swollen joint for at least 3 consecutive months
    3. No radiographic progression defined as change that does not exceed the
    smallest detectable change over one year
    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 No
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Last Patient, Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    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 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 state20
    F.4.2 For a multinational trial
    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)
    Normal care
    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 Decision2009-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-11
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