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    Summary
    EudraCT Number:2010-018674-20
    Sponsor's Protocol Code Number:IM101-226
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-12-17
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-018674-20
    A.3Full title of the trial
    A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults with Very Early RA
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberIM101-226
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorBristol Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 nameAbatacept
    D.3.2Product code BMS188667
    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.3.9.1CAS number 332348-12-6
    D.3.9.2Current sponsor codeBMS-188667
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 METHOTREXATE HOSPIRA 2.5 mg tablety
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMethotrexate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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) 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
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rheumatoid Arthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039073
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The 2 co-primary objectives for this study will compare the clinical efficacy of abatacept in combination with methotrexate to methotrexate alone on the following: 1) The proportion of randomized and treated subjects with DAS28-CRP < 2.6 at Month 12. 2) The proportion of randomized and treated subjects with DAS28-CRP < 2.6 at both Month 12 and Month 18
    E.2.2Secondary objectives of the trial
    1) Assess physical function and health-related quality of life using HAQ and SF-36 (V2.0) in the abatacept/MTX combination, abatacept monotherapy, and MTX monotherapy arms 2) Assess joint damage progression by MRI scoring at Months 6, 12, 18, and 24 in the abatacept/MTX combination, abatacept monotherapy, and MTX monotherapy arms 3) Assess safety and tolerability including immunogenicity in the abatacept/MTX combination, abatacept monotherapy, and MTX monotherapy arms. 4) Assess the proportion of randomized and treated subjects in the abatacept monotherapy arm with a) DAS28-CRP < 2.6 at Month 12 and b) subjects with DAS28-CRP < 2.6 at both Month 12 and Month 18
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1/ Signed Written Informed Consent a) Subject is willing to participate in the study and signed the informed consent 2/ Target Population a) Subjects have active clinical synovitis of at least 2 joints, 1 of which must be a small joint, for at least 8 weeks at the Screening Visit. Distal interphalangeal joints (DIP)s do not count toward this requirement b) Subjects have had the onset of persistent symptoms for ≤ 2 years prior to the Screening Visit. c) Subjects have a DAS28-CRP ≥ 3.2 at the Screening Visit d) Subjects are positive for anti-CCP2. e) Subjects are MTX naive or have minimum exposure to MTX defined as no more than 10 mg/wk for no more than 4 weeks and no dose for 1 month prior to the Screening Visit. f) Subjects are biologic naive and have not received treatment with an approved or investigational biologic RA therapy (for ex, infliximab, etanercept, anakinra, adalimumab, rituximab, tocilizumab, golimumab, and certolizumab) prior to screening. g) Subjects receiving oral corticosteroid treatment must be at the equivalent of ≤ 10 mg predinisone daily for ≥ 3 months prior to randomization. 3/ Age and Reproductive Status a) Men and women, ages ≥ 18 b) Men and women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study for up to 10 weeks (14 weeks for EU) after the last dose of abatacept in such a manner that the risk of pregnancy is minimized. See Protocol Section 3.3.4 for the definition of WOCBP. c) Women 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 investigational product. d) Women must not be breastfeeding e) Investigators should follow the manufacturer’s recommendations for MTX. f) Subjects must be able to receive an MRI. See Protocol Section 3.3.4 for contraindications
    E.4Principal exclusion criteria
    1.Target Disease Exceptions a)Subjects who meet diagnostic criteria for other rheumatic disease(eg.lupus erythematosus).2.Medical History and Concurrent Diseases a)Subjects who are impaired,incapacitated,or incapable of completing study related assessments. b)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. c) Female subjects who had a breast cancer screening study that is suspicious for malignancy,and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations d)Subjects with a history of cancer within the last 5 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 carcinoma in situ, treated with definitive surgical intervention prior to study entry, are allowed. e)Subjects who have clinically significant drug or alcohol abuse.f) Subjects with any serious acute bacterial infection(such as pneumonia or pyelonephritis unless treated and completely resolved with antibiotics). g)Subjects with severe chronic or recurrent bacterial infections(such as recurrent pneumonia, chronic bronchiectasis). h)Subjects at risk for tuberculosis (TB).Specifically, subjects with: i)Current clinical, radiographic or laboratory evidence of active TB. ii)A history of active TB within the last 3 years even if it was treated. iii)A history of active TB greater than 3 years ago unless there is documentation that the prior anti-TB treatment was appropriate in duration and type. iv)Latent TB which was not successfully treated. Subjects with a positive TB screening test indicative of latent TB will not be eligible for the study unless active TB infection has been ruled out and they have initiated treatment for latent TB with isoniazid (INH) for at least 4 weeks prior to dosing of study drug and they have a negative chest x-ray at enrollment.Such subjects should complete 9 months of INH treatment. i) Subjects with herpes zoster that resolved less than 2 months prior to enrollment. j)Subjects with evidence (as assessed by the investigator) of active or latent bacterial or viral infections at the time of potential enrollment,including subjects with evidence of Human Immunodeficiency Virus(HIV) infection 3.Physical and Laboratory Test Findings a)Hepatitis B surface antigen-positive subjects. b) Hepatitis C antibody-positive subjects who are also RIBA-positive or PCR positive. c)Subjects with any of the following laboratory values: i)Hgb < 8.5 g/dL. ii)WBC < 3,000/mm3 (3 x 109/L) iii)Platelets < 100,000/mm3 (100 x 109/L). iv)Serum creatinine > 2 times upper limit of normal. v)Serum ALT or AST > 2 times upper limit of normal. vi)Any other laboratory test results that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study. 4.Allergies and Adverse Drug Reaction a)None 5.Prohibited Treatments and/or Therapies a)Subjects who have had prior exposure to abatacept(CTLA4-Ig) b)Subjects who have been exposed to any investigational drug within 4 weeks or 5 half-lives,whichever is longer.c) Subjects currently(or in the last 3 months)receiving treatment with azathioprine,gold,leflunomide, immunoadsorption columns(such as Prosorba columns),mycophenylate mofetil (CellCept),cyclosporin,other calcineurin inhibitors or D-Penicillamine.d)Subjects who have received any live vaccines within 3 months of study drug administration or are scheduled to receive live vaccines. 6.Sex&Reproductive Status:Sexually active fertile men not using effective birth control if their partners are WOCBP
    E.5 End points
    E.5.1Primary end point(s)
    The co-primary endpoints are: 1) The proportion of randomized and treated subjects in remission (DAS28-CRP < 2.6) at Month 12 in the Treatment Period 2) The proportion of randomized and treated subjects in remission at both Month 12 and Month 18
    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 No
    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
    Immunogenicity
    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 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) Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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 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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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.1.1.1In 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.1.3Elderly (>=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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 212
    F.4.2.2In the whole clinical trial 470
    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 Decision2010-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-21
    P. End of Trial
    P.End of Trial StatusCompleted
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