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    Summary
    EudraCT Number:2006-003371-13
    Sponsor's Protocol Code Number:IM101-084
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-07-14
    Trial results Removed from public view
    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 number2006-003371-13
    A.3Full title of the trial
    A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberIM101-084
    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.3.4Pharmaceutical form Powder for solution for injection
    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.3.10 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 typeNon Applicabile
    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 placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn's Disease, NOS
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Placebo-Controlled Induction Period: Compare the proportion of subjects who have a clinical response (as defined by a reduction in Crohn’s Disease Activity Index [CDAI] >= 100 or an absolute CDAI score < 150) at both Day IP-57 (Week 8) and Day IP-85 (Week 12) between the abatacept and placebo treatment regimens. Maintenance Period: Compare the proportion of subjects who are in clinical remission (CDAI < 150) at Day MP-365 (12 months) between the abatacept and placebo treatment regimens. Open-label Extension Phase: Assess the long-term clinical safety and tolerability of abatacept treatment.
    E.2.2Secondary objectives of the trial
    Induction Period: -Compare proportion of subjects in clinical remission at both Day IP-57 & IP-85 between the abatacept and placebo treatment regimens -Evaluate dose-response relationship by comparing proportions of subjects with a clinical response at both Day IP-57 & IP-85 induced by placebo & abatacept in increasing doses -Assess improvements in quality of life at Day IP-85 using the IBD Questionnaire in abatacept vs. placebo treated subjects. Maintenance Period: -compare proportion of subjects between abatacept & placebo treatment regimens: who have a clinical response at Day MP-365; in clinical remission at both Day MP-169 & MP-365 -Assess in abatacept vs. placebo treated subjects improvements in quality of life using SF-36 and IBD Questionnaire. IP+MP: -Assess tolerability & safety of abatacept in subjects with CD; -Assess immunogenicity of abatacept in subject with CD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Signed written informed consent 2) Subject must have had CD for at least 3 months from the time of initial diagnosis. Active CD must be confirmed by radiologic, endoscopic or histologic evidence within the previous 12 months. If previous confirmation of diagnosis is not available or if previous diagnosis is not deemed conclusive at time of screening, CD diagnosis should be confirmed by endoscopy, radiology or histology. 3) Subjects must satisfy at least one of the following criteria: a) Having had an inadequate response to at least 1 of the following treatments (subjects may be currently receiving 1 of these medications or have received them previously): i) oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, balsalizide)at or above the approved label dose for at least 8 weeks and/or ii) oral prednisone >= 30 mg/day (or equivalent) or budesonide >= 9 mg/day 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] or methotrexate >=15 mg/week) 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 b) Have been intolerant to one of the above mentioned treatments (e.g.,unable to achieve doses or treatment durations because of dose limiting side effects [e.g.,leukopenia]). Subjects currently receiving and tolerating the above mentioned treatments (with the exception of anti-TNF agents) should continue their treatment (see Drug Stabilization Requirements on next page and 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 entry into the Induction Period. Acceptable documentation of inadequate response or intolerance in subjects include 1 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 CD therapy that is maintaining clinical remission, for the purpose of meeting eligibility requirements to enroll into this study. 4) Moderate to severe CD as measured by a CDAI score >= 220 and <=450 5) hsCRP > Upper Limit of Normal (ULN) 6) Oral corticosteroid treatment must have been reduced to the equivalent of <= 30 mg prednisone or <=9 mg budesonide daily at a stable dose for at least 2 weeks prior to entry into the Induction Period 7) Oral aminosalicylates should be at a stable dose for at least 2 weeks prior to entry into the Induction Period 8) Azathioprine, 6-mercaptopurine and methotrexate should be at a stable dose for at least 8 weeks prior to entry into the Induction Period 9) Men and women, ages >=18
    E.4Principal exclusion criteria
    1)WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 10 weeks after the study 2)WOCBP using a prohibited contraceptive method (there are no prohibited methods for this study) 3)Women who are pregnant or breastfeeding 4)Women with a positive pregnancy test on enrollment or prior to study drug administration 5)Diagnosis of Ulcerative or Indeterminate Colitis 6)CD isolated to the stomach,duodenum, jejunum, or perianal region, without colonic or ileal involvement 7)Suspected or diagnosed intra-abdominal or perianal abscess at screening 8)Known strictures or stenosis leading to symptoms or obstruction 9)Current evidence of fulminant colitis, toxic megacolon or bowel perforation 10)Current need for colostomy or ileostomy or use of seton for perianal disease 11)Previous total proctocolectomy or subtotal colectomy with ileorectal anastomosis 12) Surgical bowel resection within 6 months before screening 13) Extensive small bowel resection ( >100cm) or known short bowel syndrome 14) Primary sclerosing cholangitis (PSC) 15) Currently receiving total parenteral nutrition 16) Past or current evidence of definite low grade or high grade colonic dysplasia 17) Subjects who are scheduled or anticipate the need for surgery, aside from dermatologic procedures 18) Subjects who have a history of clinically significant drug or alcohol abuse 19) Concomitant illness that in the opinion of the Investigator, is likely to require systemic glucocorticosteroid therapy during the study (e.g.; moderate to severe asthma) 20) Current symptoms of severe, progressive, or uncontrolled renal, hepatic,hematological, pulmonary, cardiac, neurological, ophthalmologic 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 21) 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 enrollment. Subjects with carcinoma in situ, treated with definitive surgical intervention, are allowed 22) Subjects at risk for tuberculosis (TB). Specifically, subjects with: a. A history of active TB within the last 3 years even if it was treated b. 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 c. Current clinical, radiographic or laboratory evidence of active TB d. 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 2 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. 23) Subjects with any serious bacterial infection within the last 3 months, unless treated and resolved with antibiotics, or any chronic bacterial infection (such as chronic pyelonephritis, osteomyelitis and bronchiectasis) 24) Female subjects who have had a breast cancer screening that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations 25) 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), Hepatitis B or Hepatitis C infection detected during screening 26) Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than 2 months prior to signing informed consent
    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/~10mg/kg treatment regimen versus placebo and abatacept ~10mg/kg treatment regimen versus placebo who are in clinical response on Days IP-71 and 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 factors: 1)disease severity, and 2) concomitant use of immunosuppressants. The primary efficacy assessment of the Maintenance Period will test for treatment differences in the proportion of subjects who are in clinical remission 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) disease activity following Induction therapy, and 2) concomitant use of immunosuppressants. Safety analysis: 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 Analysis: 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 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) 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    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 years5
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months5
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 228
    F.4.2.2In the whole clinical trial 906
    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 CD or the CD 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 Decision2007-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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