Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   41201   clinical trials with a EudraCT protocol, of which   6744   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) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-002491-24
    Sponsor's Protocol Code Number:BMS-IM101-563
    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:2016-03-30
    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 number2015-002491-24
    A.3Full title of the trial
    Safety of Abatacept in patients with interstitial lung disease and common variable immunodeficiency (CVID) and related disease
    Sicherheit von Abatacept bei der Behandlung von interstitiellen Lungenerkrankungen (ILD) bei Patienten mit variablem Immundefekt (CVID) und ähnlichen Erkrankungen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety of Abatacept in patients with interstitial lung disease and common variable immunodeficiency (CVID) and related disease
    Sicherheit von Abatacept bei der Behandlung von interstitiellen Lungenerkrankungen (ILD) bei Patienten mit variablem Immundefekt (CVID) und ähnlichen Erkrankungen.
    A.3.2Name or abbreviated title of the trial where available
    SAIL
    A.4.1Sponsor's protocol code numberBMS-IM101-563
    A.5.4Other Identifiers
    Name:DRKSNumber:DRKS00008783
    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 SponsorUniversitätsklinikum Freiburg, vertreten durch den Leitenden Ärztlichen Direktor
    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 supportBristol-Myers Squibb GmbH und Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Freiburg
    B.5.2Functional name of contact pointClinical Trials unit
    B.5.3 Address:
    B.5.3.1Street AddressElsässerstr. 2
    B.5.3.2Town/ cityFreiburg
    B.5.3.3Post code79106
    B.5.3.4CountryGermany
    B.5.4Telephone number+490761270-74040
    B.5.5Fax number+490761270-74250
    B.5.6E-mailsabine.schneider-fuchs@uniklinik-freiburg.de
    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® 125 mg solution for injection in pre-filled syringe
    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 name Abatacept
    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 Yes
    D.3.11.13.1Other medicinal product typeFusion 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
    CVID patients confirmed according to ESID/PAGID criteria or related disorders which fulfill the diagnostic criteria for CVID and interstitial lung disease or granuloma diagnosed by chest CT positive for nodules, lines or ground-glass signs
    E.1.1.1Medical condition in easily understood language
    Patients with common variable immunodeficiency who suffer from inflammatory, non- infectious lung disease diagnosed by chest CT
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10022611
    E.1.2Term Interstitial lung disease
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10021449
    E.1.2Term Immunodeficiency common variable
    E.1.2System Organ Class 10021428 - Immune system disorders
    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 safety of Abatacept for interstitial lung disease in patients with CVID and related disorders
    E.2.2Secondary objectives of the trial
    To assess the efficacy of Abatacept on interstitial lung disease in patients with CVID and related disorders
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of CVID according to ESID/PAGID criteria or diagnosis of related disorders which fulfill the diagnostic criteria for CVID
    2. Interstitial lung disease or granuloma diagnosed by chest CT positive for nodules, lines or ground-glass signs
    3. Age 18 years and above
    4. Signed written informed consent
    5. Not responsive to steroid monotherapy for a minimum of three months or intolerance of steroid therapy
    6. Need for intervention measured by either reduced oxygen saturation, drop of oxygen saturation under exercise or reduced DLCOcSB
    OR
    progress of interstitial lung disease measured by progressive changes in the CT scan of the lung
    E.4Principal exclusion criteria
    1. Patient without legal capacity who is unable to understand the nature, significance and consequences of the study
    2. Other immunosuppressive therapy including biologicals beyond steroid at screening phase
    3. Previous treatment with Abatacept
    4. Active Hepatitis B infection or tuberculosis infection
    5. Other Uncontrolled infection
    6. Lymphoma within the past 5 years
    7. Pregnancy indicated by positive urine pregnancy test at screening
    8. Breast feeding patients
    9. Fertile patients refusing to use safe contraceptive methods during the study
    10. Simultaneous participation in other interventional clinical trials
    E.5 End points
    E.5.1Primary end point(s)
    (1) Number and type of severe infections (intravenous treatment, hospitalization, ICU, opportunistic infection, death) under treatment
    (2) Number, type and severity of all other (serious) adverse events ((S)AE) in relation to study drug
    E.5.1.1Timepoint(s) of evaluation of this end point
    (1) 12 months retrospective documentation before BaselineVisit (Day 0), BaselineVisit (Day 0), 3 months (Visit 1), 6 months (Visit 2), 12 months (Final Visit)
    (2) during screening up to 3 months before BaselineVisit (Day 0), BaselineVisit (Day 0), 3 months (Visit 1), 6 months (Visit 2), 12 months (Final Visit), 13 months (Follow-up via phone call)
    E.5.2Secondary end point(s)
    (1) Lung function parameters (DLCOcSB, FVC, DLCOc/VA, TLC SB, Predicted forced expiratory volume in one second FEV1 [L])
    (2) pO2 at rest and under exercise (six minute walking test)
    (3) Laboratory parameters: sIL-2-receptor, Neopterin
    (4) CT scan lung: Global and specific score for nodules, lines, consolidation and ground glass
    (5) Cumulative steroid dose
    (6) Quality of life measured by SF36, CRDQ and SGRQ
    (7) Overall Survival
    (8) Immune phenotype of B- and T-cells
    E.5.2.1Timepoint(s) of evaluation of this end point
    (1), (2, pO2 at rest), (3): 12 months retrospective documentation before BaselineVisit (Day 0), BaselineVisit (Day 0), 3 months (Visit 1), 6 months (Visit 2), 12 months (Final Visit)
    (2) pO2 under exercise: 12 months retrospective documentation before BaselineVisit (Day 0), BaselineVisit (Day 0), 12 months (Final Visit)
    (4) 12 months retrospective documentation before BaselineVisit (Day 0), BaselineVisit (Day 0), 12 months (Final Visit)
    (5) BaselineVisit (Day 0), 3 months (Visit 1), 6 months (Visit 2), 12 months (Final Visit)
    (6) SF36: BaselineVisit (Day 0), 12 months (Final Visit);
    CRDQ and SGRQ: BaselineVisit (Day 0), 6 months (Visit 2), 12 months (Final Visit)
    (7) All visits
    (8) BaselineVisit (Day 0), 12 months (Final Visit)
    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 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.8.2.4Number of treatment arms in the trial1
    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, however a follow-up visit 4 weeks after study end will be performed by telephone call by the study nurse. All (S)AEs will be documented.
    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 months0
    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 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.1.2.1Number of subjects for this age range: 7
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state10
    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)
    After end of the trial, continuation of trial medication is at the discretion of the treating physician. The patients will be seen regularly every 3 or 6 months in out patient clinic during their routine outpatient visits.
    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 Decision2016-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-26
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA