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    Summary
    EudraCT Number:2006-003604-19
    Sponsor's Protocol Code Number:IM101108
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-02-20
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2006-003604-19
    A.3Full title of the trial
    A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the
    Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in
    Subjects with Active Ulcerative Colitis (UC) who have had an Inadequate Clinical
    Response and/or Intolerance to Medical Therapy.

    Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (v2.0, Date: 02-Nov-06). + Protocol amendment 04 (Biopsy substudy) - Site specific
    A.4.1Sponsor's protocol code numberIM101108
    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 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
    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 codeCTLA4Ig
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    ULCERATIVE COLITIS,NOS
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    *Induction Period (IP):
    Compare the proportion of subjects in clinical response (defined as a reduction from
    baseline in Mayo score of >= 3 points and >= 30%, with an accompanying decrease from baseline in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of +< 1 point) at Week 12 (Day IP-85) between the abatacept and placebo treatment regimens.

    *Maintenance Period (MP):
    Compare the proportion of subjects who have a clinical response (defined as a reduction from baseline in Mayo score of >= 3 points and >= 30%, with an accompanying decrease from baseline in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of =< 1) at Month 12 (Day MP-365) between the abatacept and placebo treatment regimens.

    Open-Label Extension Phase (OL):
    Assess the long-term clinical safety and tolerability of abatacept treatment during the
    Open-Label Extension Phase.
    E.2.2Secondary objectives of the trial
    IP:
    -Compare proportion of subjects between abatacept & placebo treatment regimens
    •in clinical remission at Week 12
    •with mucosal healing at Week 12
    -Evaluate dose-response relationship by comparing proportions of subjects in clinical response at Week 12 induced by placebo & abatacept in increasing doses
    -Assess in abatacept vs placebo treated subjects improvements in QoL as measured by IBDQ score at Week 12

    MP:
    -Compare proportion of subjects between abatacept & placebo treatment regimens:
    •in clinical remission at Month 12 / at both Month 6 & 12
    •with mucosal healing at Month 12
    •using oral corticosteroids at baseline who discontinued corticosteroids & are in remission at Month 12
    -Assess in abatacept vs placebo treated subjects improvements in QoL as measured by IBDQ score & SF-36 at Month 12

    IP + MP:
    -Assess immunogenicity, tolerability & safety of abatacept in subjects with UC

    See Protocol Sections 2.1.2, 2.2.2, 2.3.2 for additional secondary objectives
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Protocol amendment 04 - Biopsy substudy - site specific - v2.0 - 31May2007

    This substudy will assess the effect of abatacept therapy on:
    1) Microscopic disease activity by examining serial biopsies for changes in histological
    parameters utilizing the Geboes Index scoring system.
    2) Changes in the composition of the inflammatory infiltrate, and impact on tissue
    healing by assessing the expression of select molecular markers by immunohistochemistry.
    E.3Principal inclusion criteria
    1) Signed written informed consent
    2) Subject must have had ulcerative colitis (UC) for at least 3 months from the time of
    initial diagnosis. The diagnosis of UC must have been confirmed by endoscopic and
    histologic evidence. If no previous confirmation of diagnosis is available or if previous diagnosis is not deemed conclusive, at time of screening endoscopy, histology should be performed to confirm diagnosis of UC
    3) Subjects must satisfy one of the following criteria:
    a) In the past, had an inadequate response to one or more of the following
    treatments:
    i) Oral aminosalicylates (e.g. mesalamine, sulfasalazine, olsalazine, balsalizide) at
    or above the approved label dose for induction therapy for at least 6 weeks, and/or
    ii) Prednisone >= 40 mg/day (or equivalent) for at least 2 weeks, and/or
    iii) Immunosuppressants [azathioprine >= 2 mg/kg/day or 6-mercaptopurine >=
    1.0 mg/kg/day, (or documentation of a therapeutic concentration of
    6-thioguanine nucleotide)] for at least 12 weeks, and/or
    iv) An approved anti-TNF agent at an approved labeled dose for at least 8 weeks
    and/or
    v) Intravenous hydrocortisone >= 400 mg/day (or equivalent) for at least 1 week.
    AND/OR
    b) had been intolerant to one or more of the above mentioned treatments [e.g,
    unableto achieve doses or treatment durations because of dose limiting side
    effects (e.g. leukopenia, psychosis, uncontrolled diabetes, elevated liver enzymes)]
    AND/OR
    c) Currently receiving one or more of the following treatments:
    i) Oral aminosalicylates (e.g. mesalamine, sulfasalazine, olsalazine, balsalizide) at
    or above the approved label dose for at least 6 weeks and/or
    ii) Prednisone ≥ 20 mg/day (or equivalent) for at least 4 weeks and/or
    iii) Immunosuppressants [azathioprine >= 2 mg/kg/day or 6-mercaptopurine
    >= 1.0 mg/kg/day, (or documentation of a therapeutic concentration of
    6-thioguanine nucleotide)] for at least 12 weeks.
    Subjects currently receiving oral corticosteroids, oral aminosalicylates, azathioprine, or 6-mercaptopurine should continue their treatment (see Protocol Section 6.4.2.1). Subjects who had an inadequate response and/or intolerance to anti-TNF treatment must have had their last dose at least 8 weeks prior to the entry into the Induction Period. Subjects who had an inadequate response and/or intolerance to intravenous corticosteroid treatment must have had their last dose at least 4 weeks prior to entry into the Induction Period.
    Inadequate response and/or intolerance in the past (as defined above) will be assessed by the treating physician. Acceptable documentation of inadequate response or intolerance in subjects include one or more of the following: medical records; letters provided by the referring physician; other referral documents (e.g., insurance authorization forms), provided they contain the relevant information to support the subject’s ‘inadequate response’ and/or ‘intolerance’ to the designated therapy.
    In all circumstances, it should be established that discontinuation of the designated
    treatments was primarily due to lack of efficacy or intolerance (e.g., not due to
    unavailability of the drug).
    Subjects in clinical remission should not discontinue UC therapy that is maintaining
    clinical remission, for the purpose of meeting eligibility requirements to enroll into this
    study.
    4) Subjects must have a Mayo score >= 6 and an endoscopic subscore of >= 2
    5) Oral corticosteroid treatment must have been the equivalent of =< 30 mg prednisone daily at a stable dose for at least 2 weeks prior to entry into the Induction Period
    6) Oral aminosalicylates should be at a stable dose for at least 2 weeks prior to entry into the Induction Period
    7) Azathioprine or 6-mercaptopurine should be at a stable dose for at least 8 weeks prior to entry into the Induction Period
    8) Men and women, ages >= 18
    E.4Principal exclusion criteria
    -WOCBP unwilling or unable to use an acceptable method to avoid pregnancy for entire study period & for up to 10 weeks after study (14 weeks for the European countries in which the European SmPC for Orencia™ IV is applicable)
    -WOCBP using prohibited contraceptive method
    -Pregnant or breastfeeding women
    -Women with positive pregnancy test on enrollment or prior to study drug administration
    -Diagnosis of Crohn’s Disease(CD), or Indeterminate Colitis or clinical findings suggestive of CD
    -Diagnosis of UC limited to rectum (ulcerative proctitis)
    -Current evidence of fulminant colitis, toxic megacolon or bowel perforation
    -Current need for colostomy or ileostomy
    -Previous total proctocolectomy or subtotal colectomy with ileorectal anastomosis, any surgical resection for UC
    -Surgical bowel resection within 6 months before screening for reasons other than UC
    -Primary sclerosing cholangitis(PSC)
    -Currently receiving total parenteral nutrition(TPN)
    -Required IV corticosteroids for UC 2 weeks before screening
    -Past or current evidence of definite colonic dysplasia
    -Subjects who are scheduled or anticipate need for surgery, aside from dermatologic procedures
    -Subjects with history of clinically significant drug or alcohol abuse
    -Concomitant illness likely to require systemic glucocorticosteroid therapy during study
    -Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, pulmonary, cardiac, neurological, ophthalmologic or cerebral disease Concomitant medical conditions that might place subject at unacceptable risk for participation in study
    -Subjects with a history or current evidence of malignancies; specifically, subjects with:
    a) a history of cancer within the last five years (other than non-melanoma skin cell
    cancers cured by local resection), or
    b) evidence of malignancies (including that detected by screening procedures), or
    c) signs of possible malignancies detected by screening procedures for which the
    workup to exclude malignancy has not been completed.
    The following subjects may be enrolled; those with:
    a) existing non-melanoma skin cell cancers which have been entirely removed prior
    to randomization, or
    b) carcinoma in situ, treated with definitive surgical intervention
    c) no evidence of malignancy upon completion of evaluation prompted by
    suspicious screening procedure
    -Subjects at risk for tuberculosis. Specifically, subjects with:
    a)history of active TB within last 3 years even if it was treated
    b)history of active TB >3 years ago unless there is documentation that prior anti-TB treatment was appropriate in duration & type
    c)Current clinical, radiographic or laboratory evidence of active TB
    d)Latent TB which was not successfully treated. Positive TB screening test indicative of latent TB would not be eligible unless active TB infection has been ruled out & they have initiated treatment for latent TB with isoniazid(INH) for at least 2 weeks prior to entry in Induction Period (IP) & they have negative chest x-ray at enrollment. Such subjects must complete 9 months of INH treatment
    -Subjects with any serious bacterial infection within last 3 months, unless treated & resolved with antibiotics, or any chronic bacterial infection
    -Female subjects who have had breast cancer screening suspicious for
    malignancy, & in whom possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations
    -Evidence of active or latent bacterial or viral infections at time of potential enrollment, incl. subjects with evidence of HIV, Hepatitis B or HPC infection detected during screening
    -Subjects with herpes zoster or CMV that resolved< 2 months prior to signing ICF
    -Subject who received any live vaccines within 3 months of anticipated 1st dose of study medication or who will have need of a live vaccine at any time following entry in IP
    -Clinically significant abnormal chest x-ray at screening
    -Positive stool culture for enteric pathogens
    -Stool positive for c. difficile toxin
    Any of following lab values:
    a)Hgb< 8.5 g/dL
    b)WBC< 3,000/mm³ (3 x 109/L)
    c)Platelets< 100,000/mm³ (100 x 109/L)
    d)Serum creatinine> 2x upper limit of normal
    e)Serum ALT or AST> 3x upper limit of normal
    f)Any other laboratory test results that might place subject at unacceptable risk for participation in study
    -History of severe or anaphylactic infusion reaction after receiving a biologic agent, suspected to be associated with an immune response
    -CTLA4Ig or abatacept at any time prior to screening
    -Any marketed biologic used for UC (including infliximab) within 8 weeks before
    entry in IP
    -Any biologic immunomodulators used for UC or other conditions within 8 weeks
    before entry in IP
    -Rituximab within 1 year before screening

    See Protocol Section 5.2 for additional Exclusion Criteria
    E.5 End points
    E.5.1Primary end point(s)
    * The Induction Period’s primary efficacy assessment will test for differences in the proportion of subjects in the Induction Period abatacept 30/~10 mg/kg treatment regimen versus placebo and abatacept ~10 mg/kg treatment regimen versus placebo in clinical response on Day IP-85. The Induction Period’s two primary comparisons will be tested using the Cochran-Mantel-Haenszel (CMH) Chi-square test at the 5% level of significance with stratification according to the Induction Period stratification factor of having had an inadequate response and/or intolerance to anti-TNF therapy.

    * The primary efficacy assessment of the Maintenance Period will test for treatment differences in the proportion of subjects in clinical response at Day MP-365. The CMH Chi-square test will be used to compare the two treatment groups at the 5% level of significance, with stratification according to the Maintenance Period stratification factors:
    1) concomitant use of oral corticosteroids;
    2) clinical remission status at Day IP-85;
    3) having had an inadequate response and/or intolerance to anti-TNF therapy.

    * Safety Assessments
    Significant physical examination findings, and clinical and laboratory test results will be listed. Summary statistics will be tabulated. Frequency distributions and individual
    listings of all adverse events will be generated. Changes from baseline in clinical
    laboratory test results will be listed.

    * PK Assesments
    Summary statistics will be tabulated for PK parameters by dose groups. Geometric means and coefficients of variation will be presented for Cmax, Cmin and AUC (TAU).
    Medians and ranges (minimum and maximum) will be presented for Tmax.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity + health related Quality of Life: IBD Questionnaire and SF-36 Questionnaire
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.6Cross over Yes
    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.8.3 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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA45
    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 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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    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 months9
    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 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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 193
    F.4.2.2In the whole clinical trial 978
    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)
    The Open-label Extension (OL) phase will be offered to subjects who complete the 12- week Induction Period and do not meet responder criteria at Day IP-85, subjects who experience disease relapse during the Maintenance Period, and subjects who complete the Maintenance Period. To allow for the continued collection of safety data in an open-label long-term extension phase, the Open-label Extension will continue until the drug is marketed for UC or the UC development program is discontinued.
    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 Decision2007-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
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