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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41189   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2007-002967-28
    Sponsor's Protocol Code Number:ABATACEPT-AS-01
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-08-24
    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 ConcernedGermany - PEI
    A.2EudraCT number2007-002967-28
    A.3Full title of the trial
    Pilot open label clinical trial with Abatacept in Ankylosing Spondylitis
    A.3.2Name or abbreviated title of the trial where available
    ABATACEPT-AS-01
    A.4.1Sponsor's protocol code numberABATACEPT-AS-01
    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 SponsorCharité University Medicine
    B.1.3.4CountryGermany
    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 No
    D.2.1.1.1Trade name not applicable
    D.2.1.1.2Name of the Marketing Authorisation holdernot applicable
    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 BMS-188667
    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.3.9.3Other 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 typeAbatacept is a recombinant fusion protein consisting of the extracellular domain of human CTLA4 and a fragment (hinge - CH2 - CH3 domains) of the Fc domain of human IgG1
    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
    T cell responses have been demonstrated against proteoglycan (an important cartilage protein) in human arthritides including ankylosing spondylitis. We suggest that a chronic, probably T cell mediated, immune response against cartilage is relevant in the pathogenesis of AS.
    Based on the above described findings about the role of T-cells in ankylosing spondylitis we assume that Abatacept has the potential to be an effective drug for treating ankylosing spondylitis.
    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
    The primary endpint will be the ASAS40 response rate in TNF-blocker naïve and in TNF-blocker failure patients at week 24. We postulate that at least 30% of the patients will achieve an ASAS40 response. Given the good efficacy of the TNF-blocking agents, abatacept would not be an interesting treatment if the response rate were lower.
    E.2.2Secondary objectives of the trial
    Safety Evaluations: Adverse events, vital signs, physical examination results, and clinical laboratory values until week 36.

    Efficacy Evaluations: ASAS 20 response, ASAS criteria for partial remission, duration of response, BASDAI 20%, 50%, 70% improvement, BASFI, mobility examinations: BASMI, Chest Wall Expansion, disease controlling antirheumatic therapy criteria (DC-ART20) (5 out of 6), CRP, ESR, quality of Life: SF-36, AS-QoL, EQ-5D; Numeric Rating Scale (NRS) – physicians global, patients global, general pain, nocturnal pain; enthesitis index (Maastricht scale) swollen and tender joint count; socio-economic questionnaire, course of change of active and chronic inflammatory lesions in MRI after 24 weeks Immune monitoring at inclusion and monthly thereafter for 24 weeks: number of T cells, activation of T cells, parameters of apoptosis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Only patients with moderate to severe ankylosing spondylitis will be included. This implies that only patients with radiological evidence of sacroiliitis (fulfilling the modified New York criteria for AS) will be included.

    1) Patients 18- 65 years of age who have moderate to severe ankylosing spondylitis.

    2)
    Group 1: TNFalpha inhibitor naïve patients: active AS patients with inadequate response to conventional therapy (e.g. NSAIDs, glucocorticosteroids or DMARDs) or with intolerance of conventional therapy.

    Group 2: TNFalpha inhibitor failures: active AS patients with inadaequate response to treatment with TNFalpha inhibitors (= patients with previous treatment with TNFalpha inhibitors who showed an inadaquate response according to the international ASAS recommendations; NOT AS patients who had to discontinue TNFalpha inhibitor treatment because of intolerance)

    3) active disease is defined as a BASDAI score of >= 4, back pain score (BASDAI question 2) of >= 4 despite concurrent NSAID therapy, or intolerance to NSAIDs (first group) or prior treatment with TNFalpha inhibitors (second group)

    4) if on NSAIDs, dosage must be stable 2 weeks prior to baseline. During the study dosage should be stable but is allowed to be reduced if documentated.

    5) If on prednisone, <=10.0 mg per day, must be stable for 4 weeks prior to baseline and should be kept stable during the study

    6) If on sulfasalazine or methotrexate, must be stable for 4 weeks prior to baseline

    7) If on TNFalpha blocking agent (infliximab, etancercept, adalimumab), the TNFalpha-blocking therapy must have been terminated at least 4 weeks prior to baseline if etanercept was used and at least 8 weeks if infliximab or adalimumab were used.
    E.4Principal exclusion criteria
    1) Current clinical or laboratory evidence of active or latent tuberculosis (TB) and subjects with a history of active TB treated within the last 3 years --> all potential subjects will have a screening chest x-ray at baseline (acceptable if present within the last 3 months); all potential subjects will have a Tuberculin skin test at screening
    2) Patients with other chronic inflammatory articular disease or systemic autoimmune disease, e.g. Systemic lupus erythematosus, Sjögren’s syndrome, active rheumatoid vasculitis, a history of systemic diseases associated with arthritis, chronic fatigue syndrome (other manifestations of spondyloarthritis such as psoriasis, inflammatory bowel disease, arthritis, uveitis are not regarded as exclusion criteria)
    3) Any active infection, a history of recurrent clinically significant infection, a history of recurrent bacterial infections with encapsulated organisms
    4) Hepatitis B or C or HIV
    5) Primary or secondary immunodeficiency.
    6) History of cancer with curative treatment not longer than 5 years ago except basal-cell carcinoma of the skin that had been excised
    7) A history of pulmonary or cardiac insufficiency, or serious and/or uncontrolled diseases that are likely to interfere with the evaluation of the patient's safety and of the study outcome
    8) Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease ( e.g. heart failure class III/IV NYHA, cardiac infarct within last 6 month)
    9) nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders
    10) Neuropathy that can interfere with quality of life and/or pain assessment.
    11) Patients with a history of a severe psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
    12) History of current evidence of abuse of “hard” drugs (e.g. cocaine/ heroine) or alcoholism
    13) Known hypersensitivity to any component of the study medication
    14) Women lactating, pregnant, nursing or of childbearing potential with a positive pregnancy test (urine test)
    15) Males or females of reproductive potential not willing to use effective contraception (e.g. contraceptive pill, IUD, physical barrier)
    16) History of alcohol, drug or chemical abuse within 6 month prior to screening

    Exclusion criteria related to medications:
    1) if previously on TNFalpha blocking agents, discontinuation of TNFalpha-blocking agents because of intolerance.
    2) If on leflunomide, leflunomide must have been terminated at least 8 weeks prior to the first abatacept administration (or ≥ 28 days after 11 days of standard cholestyramine or activated charcoal washout).
    3) If on TNFalpha blocking agent (infliximab, etancercept, adalimumab), the TNFalapha therapy must have been terminated at least 4 weeks prior to the first abatacept adminstration if etanercept was used and at least 8 weeks if infliximab or adalimumab were used
    4) Previous treatment with abatacept or rituximab
    5) If on sulfasalazine or methotrexate, must be stable for 4 weeks prior to baseline
    6) Corticosteroids at doses exceeding 10 mg per day of prednisolone or the equivalent within the last 4 weeks prior to the first abatacept administration
    7) Previous treatment with any investigational agent within 28 days ( or less than 5 terminal half-lives of elimination) of day 1 dose
    8) Previous treatment with i.v. immunoglobulins
    9) Receipt of a live vaccine within 4 weeks prior to treatment
    10) Intra-articular or parenteral corticosteroids within 4 weeks prior to screening visit

    Exclusion criteria related to lab findings:
    1) Haemoglobin < 8.5 g/dl
    2) Neutrophil counts < 2.000 / µl
    3) Platelet count < 125.000 / µl
    4) Lower than 1 x 1000/µl lymphopenia for more than three months prior to inclusion.
    5) Serum creatinine > 1.4 mg/dl for women or 1.6 mg/dl for men.
    6) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times upper limit of normal
    7) Positive HIV, hepatitis B or C serology
    8) Any other laboratory test result that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study.

    Exclusion criteria related to formal aspects:
    1) Patients who participate currently in another clinical trial or patients who participated in another clinical trial during the last 30 days.
    2) Patients who are underage or patients who are incapable to understand the aim, importance and consequences of the study and to give legal informed consent (according to § 40 Abs. 4 and § 41 Abs. 2 und Abs. 3 AMG).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpint will be the ASAS40 response rate in TNF-blocker naïve and in TNF-blocker failure patients at week 24. We postulate that at least 30% of the patients will achieve an ASAS40 response. Given the good efficacy of the TNF-blocking agents, abatacept would not be an interesting treatment if the response rate were lower.
    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 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 Yes
    E.7.1.3.1Other trial type description
    pilot study
    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 No
    E.8.1.2Open Yes
    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 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.8.6 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 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
    All patients will undergo a screening examination prior to entering the study to confirm eligibility (first visit to collect baseline data, screening examination).
    Patients will return to the investigating center for 9 further visits. Thus, patients return to the investigating center at week 0, 2, 4, 8, 12, 16, 20, 24 / ET (early termination) and 36.
    The study ends, when the last patient underwent the contol visit in week 36.
    A
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-08-24. Yes
    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.3.3.6.1Details of subjects incapable of giving consent
    Pregnancy and breast-feeding is an exclusion criteria. At screening and baseline pregnancy tests will be performed for safety reasons. Patients have to use adaquate contraception during the study (see protocol).
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 30
    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 receive the standard treatment with standard care as needed throughout and after the study. After week 36 an additional or changed treatment is left to the discretion of the investigator.
    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 Decision2007-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-05-01
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