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    Summary
    EudraCT Number:2009-015558-40
    Sponsor's Protocol Code Number:ABACEPT1
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-12-23
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2009-015558-40
    A.3Full title of the trial
    Abatacept treatment in patients with primary Sjögren’s syndrome
    A.4.1Sponsor's protocol code numberABACEPT1
    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 Medical Center Groningen
    B.1.3.4CountryNetherlands
    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 Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    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 typerecombinant fusion 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
    Sjögren’s syndrome (SS) is a chronic, systemic, lymphoproliferative autoimmune disease affecting the exocrine glands. The salivary and lacrimal glands are most commonly affected, resulting in dry mouth and dry eyes. Extraglandular involvement can occur in SS, and includes, amongst others, pulmonary disease, renal disease and vasculitis. Moreover, almost all patients suffer from restricting fatigue.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10040767
    E.1.2Term Sjogren's syndrome
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of efficacy (as assessed by the stimulated whole saliva flow rate at 24 weeks) and safety of abatacept treatment in 15 patients with pSS.
    E.2.2Secondary objectives of the trial
    Evaluation of efficay of abatacept treatment in 15 patients with pSS on objective signs and subjective complains.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     pSS according to the revised European – U.S. criteria(22).
     Male or female  18 years.
     Stimulated whole saliva secretion  0.15 ml/min.
     Positive autoantibodies (IgM-Rf 10 and SS-A and/or SS-B).
     Parotid gland biopsy (paraffin material and fresh frozen tissue) with characteristic features of SS performed at time of inclusion (no longer than 12 months ago).
     In female patients: use of reliable method of contraception during the study and at least until 14 weeks after the last infusion, in women of child bearing potential.
     In male patients: use of reliable method of contraception during the study and at least until 14 weeks after the last infusion by partner of patient, in case the partner of the patient is a female of child bearing potential.
     Written informed consent.
     Patients are allowed to continue artificial tears and/or artificial saliva provided that the dosage and schedule regime are stable, and that the usage will be stopped one day prior to each evaluation.
    E.4Principal exclusion criteria
     Disease duration  5 years.
     The presence of any other connective tissue disease.
     Clinically significant serious abnormalities on electrocardiography or chest X ray.
     Lab abnormalities:
    o Serum creatine > 2.8 mg/dl (250 mol/l);
    o ASAT or ALAT outside 1.5 x upper normal range of the laboratory;
    o Hb < 9 g/dl (5.6 mmol/l) for males and 8.5 g/dl (5.3 mmol/l) for females;
    o Neutrophil granulocytes less than 0.5 x 109/l;
    o Platelet count less than 50 x 109/l.
     Underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases (e.g., patients with hepatitis B or C, patent tuberculosis or latent tuberculosis non-adequately treated) or immune deficiency which places the patient at an unacceptable risk for participation in the study.
     History of cancer, including mucosa associated lymphoid tissue (MALT) lymphoma in the preceding 5 years (except adequately treated basal cell carcinoma of the skin and carcinoma in situ of the skin).
     Positive pregnancy test or breast-feeding.
     Planned major surgery (e.g. joint replacement) within the duration of the treatment period of the study.
     Serious infections in the preceding month.
     Opportunistic infection in the preceding 3 months.
     Subjects with evidence of active or latent bacterial infections at the time enrollment, including subjects with evidence of Human Immunodeficiency Virus (HIV) infection.
     Subjects with current clinical or laboratory evidence of active tuberculosis (TB).
     Subjects with a history of active TB treated within the last 3 years.
     Subjects who received treatment for active TB greater than 3 years ago may be eligible for inclusion in this study if there is documentation of the prior anti-TB treatment confirming that it was appropriate in duration and type.
     Subjects with latent TB which was not successfully treated.
     Subjects with a positive TB screening test indicative of latent TB will not be eligible for this study unless active TB infection has been ruled out and they have been initiated treatment for latent TB with isoniazid (INH) for at least 4 weeks prior to dosing of Abatacept and they have a negative chest x-ray for active TB at enrollment. Such subjects should complete 9 months of INH treatment.
     Subjects with herpes zoster that resolved less than 2 months prior to enrollment.
     Preceding treatment with anti-TNF, rituximab or other monoclonal antibodies
     Use of prednisone and/or pilocarpine less than 2 weeks ago
     The use of hydroxychloroquine, azathioprine, cyclofosphamide, cyclosporine, MTX and other DMARDs should be discontinued at least 1 month prior to the first infusion of abatacept.
     History of alcohol or drug abuse.
    E.5 End points
    E.5.1Primary end point(s)
    primary endpoint:
    - Stimulated whole salivary gland function at week 24

    secundary endpoints:
    - functional parameters (clinical glandular and extraglandular examination)
    - laboratory parameters (e.g. B and T cell subsets, IgM-Rf)
    - subjective parameters (VAS scores, MFI, SF-36)
    - histological/molecular parameters
    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 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 No
    E.8.1.2Open No
    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 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 visit of the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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 state15
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 15
    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 Decision2010-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-29
    P. End of Trial
    P.End of Trial StatusOngoing
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