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    Summary
    EudraCT Number:2014-000417-31
    Sponsor's Protocol Code Number:IM101-473
    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:2014-03-20
    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 number2014-000417-31
    A.3Full title of the trial
    Randomized, double-blind, placebo-controlled phase III study (ASAP III study) to assess the efficacy and safety of Abatacept treatment in patients with primary Sjögren’s syndrome
    (ASAP III study = Abatacept Sjögren Active Patients phase III study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Abatacept treatment in primary Sjögrens Syndrome
    A.3.2Name or abbreviated title of the trial where available
    ASAPIII
    A.4.1Sponsor's protocol code numberIM101-473
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02067910
    A.7Trial is part of a Paediatric Investigation Plan No
    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 supportBristol-Myers Squibb
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressP.O. Box 30.001
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9700RB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31503613432
    B.5.5Fax number+31503619308
    B.5.6E-mailH.Bootsma@umcg.nl
    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.3.1Product nameAbatacept
    D.3.2Product code BMS-188667
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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 in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Sjögren's syndrome (pSS)
    E.1.1.1Medical condition in easily understood language
    Primary Sjögren's syndrome
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10042846
    E.1.2Term Syndrome Sjogren's
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of weekly SC administration of Abatacept vs placebo on disease activity assessed with ESSDAI at 24 weeks in patients with pSS.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of Abatacept on clinical, functional, laboratory, subjective, and histological parameters over 48 weeks in patients with pSS.
    To evaluate the safety of abatacept, by monitoring SAE, AE, related SAE and AE, treatment discontinuation related to SAE and AE, and lab abnormalities over 48 weeks in patients with pSS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed written informed consent
    - ESSDAI ≥ 5
    - Female or male ≥ 18 years
    - pSS according to the American European Consensus Group (AECG) classification criteria (6)
    - Disease duration ≤ 7 years at the moment of inclusion
    - pSS proven by parotid gland biopsy with characteristic features of SS
    - Women of child bearing (WOCBP) potential must be using an acceptable method of contraception to avoid pregnancy throughout the study and for up to 10 weeks after the last dose of study drug in such a manner that the risk of pregnancy is minimized.
    - Sexually active fertile men must use effective birth control if their partners are WOCBP
    E.4Principal exclusion criteria
    - Presence of any other connective tissue disease.
    - Flow rate of stimulated whole saliva ≤0.05 ml/min in patients without extraglandular manifestations.
    - Positive pregnancy test or breast-feeding women.
    - Women with a child-bearing potential who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the entire study period.
    - History of alcohol or drug abuse or current alcohol or drug abuse.
    - History of any malignancy in the past 5 years, including MALT lymphoma in the last 5 years, or with a current suspicion for cancer, other than non-melanoma skin cell cancers (NMSC), cured by local resection or carcinoma in situ. Existing NMSCs should be removed, the lesion site healed, and residual cancer ruled out before administration of the study drug.
    - 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) detected during screening.
    - History of chronic or recurrent serious infections. (e.g. chronic pyelonephritis, osteomyelitis or bronchiectasis).
    - Subjects with serious bacterial infections within the last 3 month, unless treated and resolved with antibiotics
    - Subjects with herpes zoster or cytomegalovirus that resolved less than 2 months before potential enrollment.
    - Subjects at risk for TB. Specifically excluded from this study will be subjects with a history of active TB within the last 3 years, even if it was treated; 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; current clinical, radiographic, or laboratory evidence of active TB; and latent TB that was not successfully treated (≥ 4 weeks).
    - Subjects must not be positive for hepatitis B surface antigen.
    - Subjects who are positive for hepatitis C antibody if the presence of hepatitis C virus was also shown with polymerase chain reaction or recombinant immunoblot assay.
    - Subjects who have received any live vaccines within 3 months before potential enrollment.
    - Underlying cardiac, pulmonary, metabolic, renal, hepatic, gastrointestinal, haematological or neurological conditions, chronic or latent infectious diseases or immune deficiency which places the patient at an unacceptable risk for participation in the study.
    - Use of prednisone ≥10 mg less than 1 month before inclusion.
    - Use of pilocarpine, hydroxychloroquine, methotrexate, cyclophosphamide, cyclosporin, azathioprine, mycophenolate mofetil (MMF) and leflunomide less than 1 month before inclusion.
    - Previously treated with biological DMARDs either marketed or under investigation.
    - Lab abnormalities:
    a. Serum creatinine ≥2.8 mg/dl (250 µmol/l)
    b. ASAT or ALAT outside 1.5 x upper normal range of the laboratory
    c. Hb &lt; 9 g/dl (5.6 mmol/l) for males and 8.5 g/dl (5.3 mmol/l) for females
    d. Neutrophil granulocytes less than 0.5 x 109/l
    e. Platelet count less than 50 x 109/l
    - Any other laboratory test results that, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study.
    - Subjects will be asked if they have allergies or adverse drug reactions. The investigator will withdraw subjects at unacceptable risk for participation from the study.
    - Prisoners or subjects who are involuntarily incarcerated.
    - Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
    - Subjects who are impaired, incapacitated, or incapable of completing study-related assessments.
    E.5 End points
    E.5.1Primary end point(s)
    ESSDAI
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    E.5.2Secondary end point(s)
    Clinical parameters
    Assessed at screening, 4, 8, 12, 24, 28, 32, 36, and 48 weeks.
    - ESSDAI (at time-points other than 24 weeks)
    - DAS28(CRP) and DAS28(ESR)
    - Corticosteroid dose (decrease, stable, increase)

    Functional parameters
    Assessed at screening, 12, 24, 36, and 48 weeks.
    - Unstimulated and paraffin stimulated whole saliva.
    - Gland-specific saliva: Sialometrical (flow rate of unstimulated and 2% w/v citric acid stimulated parotid and submandibular/sublingual saliva) and sialochemical (analysis of salivary composition, a.o., electrolytes, amylase, total protein, autoantibodies, cytokines) profile. Gland-specific saliva will be collected according to the method used by Kalk et al (2001).
    - Ocular staining score according to Whitcher et al (2010).
    - Tears collection, and determination of autoantibodies and cytokines in tears.
    - Impression cytology of the eye.

    Subjective parameters
    Assessed at screening, 4, 8, 12, 24, 28, 32, 36, and 48 weeks.
    - ESSPRI.
    - Patient global assessment of disease activity.
    - Physician global assessment of disease activity.

    Assessed at screening, 12, 24, 36, and 48 weeks
    - Fatigue (Multidimensional Fatigue Index; MFI).
    - HR-QOL (Short Form-36; SF-36).
    - Patient Acceptable Symptom State (PASS).

    Assessed at screening, week 24 and 48 in female participants
    - Female sexual function index (FSFI)
    - NRS score vaginal dryness

    Histological parameters
    - Parotid gland biopsy at 24 weeks in patients of who a recent baseline parotid gland biopsy is available and who give informed consent for a follow up biopsy.

    Laboratory parameters
    Assessed at screening, 4, 8, 12, 24, 28, 32, 36, and 48 weeks.
    - Serum levels of ANA and IgM-Rf
    - Serum levels of anti-SSA, anti-SSB
    - Immunoglobulins (IgG, IgA, IgM)
    - T and B cell subsets
    - Cytokines
    - Free light chain
    - β2 microglobulin
    - MxA
    - Complement (C3 and C4)
    - CRP
    - ESR
    - Blood cell counts
    - Kidney functions
    - Liver functions

    Safety
    Adverse events will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) v.14.0 at all time points.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Screening, 4, 8, 12, 24, 28, 32, 36 and 48 weeks.
    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) 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.8.2.4Number of treatment arms in the trial2
    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 No
    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
    LVLS
    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 months
    E.8.9.1In the Member State concerned days
    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.1.2.1Number of subjects for this age range: 66
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 state88
    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)
    Referral back to normal follow up protocol
    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 Decision2014-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-01
    P. End of Trial
    P.End of Trial StatusOngoing
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