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    The EU Clinical Trials Register currently displays   38927   clinical trials with a EudraCT protocol, of which   6396   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).
     
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    Summary
    EudraCT Number:2006-001269-40
    Sponsor's Protocol Code Number:CT-1306
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-03-11
    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 ConcernedGermany - PEI
    A.2EudraCT number2006-001269-40
    A.3Full title of the trial
    Induction of Tolerance with Immunoablation and
    Autologous Hematopoietic Stem Cell Transplantation (ASCT) for
    Severe Systemic Lupus Erythematosus (SLE) Refractory to
    Standard Immunosuppressive Therapy

    AN OPEN-LABEL, CONTROLLED, PHASE II MULTICENTER TRIAL OF IMMUNOABLATIVE CHEMOTHERAPY WITH CYCLOPHOSPHAMIDE AND ANTI-THYMOCYTE GLOBULIN AND TRANSPLANTATION OF PURIFIED CD34+ AUTOLOGOUS HEMAPOIETIC STEM CELLS VERSUS CURRENTLY AVAILABLE IMMUNOSUPPRESSIVE THERAPY FOR THE TREATMENT OF REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS.
    A.3.2Name or abbreviated title of the trial where available
    ASSIST
    A.4.1Sponsor's protocol code numberCT-1306
    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 Role
    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.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous 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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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 No
    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
    Patients with systemic lupus erythematosus (SLE) will be under investigation who show high disease activity despite treatment with standard immunosuppressive therapies: high-dose corticosteroids and pulse intravenous CYC at doses of 500-1000mg/m2 for at least 6 months or mycophenolate mofetil (MMF) at doses of at least 2g/d for at least 6 months. Active disease is defined according to BILAG-scoring level A.
    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
    To assess the safety and efficacy of immunoablation with antithymocyte globulin and cyclophosphamied followed by autologous hematopoietic stem cell transplantation versus treatment with currently available immunosuppressive/immunomodulatory therapy for refractory SLE
    E.2.2Secondary objectives of the trial
    - To assess durability of clinical response with respect to percentage and number of subjects showing complete remission at Month 48, defined as SLEDAI less than 3 in the absence of immunosuppressive therapy and prednisolone dosage ≤ 7.5mg daily.
    - To assess time-point and number of patients with relapse, defined as increase in prednisolone dosage >10mg/d (for SLE treatment) or increase in SLEDAI by at least 3 compared to previous visit
    - To assess serological response including serum autoantibody titers and complement levels C3, C4
    - To assess health related Quality of Life
    - To assess organ specific response parameters based on individual SLE manifestations
    - To assess immune reconstitution
    - To search for predictive factors favouring long-term remission
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of SLE according to American College of Rheumatology (ACR)
    classification criteria for SLE
    2. Age between 18 and 60 years, inclusive
    3. Provision of informed consent by subject or legally acceptable
    representative
    4. Severe disease, refractory to standard immunosuppressive therapy
    defined as:
    - failure of remission after treatment with high-dose corticosteroids and pulse intravenous CYC at doses of 500-1000mg/m2 for at least 6 months (defined as BILAG level A) for one of the following:
     Biopsy proven glomerulonephritis WHO class III or class IV
     Parenchymal disease of heart or lung
     Neuropsychiatric lupus
     Autoimmune cytopenia
    OR
    - recurrence of disease activity (defined as new BILAG level A) within one year of clinical remission in the presence of an adequate maintenance therapy (intravenous Cyclophosphamide, Mycophenolate Mofetil, Azathioprine, Methotrexate, IVIG, Cyclosporine, Rituximab)
    in patients with persistent anti-dsDNA antibodies
    E.4Principal exclusion criteria
    1. Severe concomitant disease or organ damage
    a) Renal: chronic renal insufficiency with creatinine-clearance <40ml/min or serum
    creatinine concentration >3mg/dl
    b) Cardiac: congestive heart failure, LVEF < 40% determined by echocardiogram
    uncontrolled arrhythmia
    c) Pulmonary: mean PAP >50mmHg, TLCO/VA <40 % predicted
    d) Gastrointestinal: liver cirrhosis (Child Pugh classification B or C)
    2. Concurrent malignancy or history of malignancy within 5 years of
    screening
    3. Women who are pregnant or breastfeeding or use non-reliable
    methods of contraception
    4. Subjects with a history of viral infection (CMV, EBV, HCV) within 6
    prior to screening, or known HIV-infection
    5. History of allergy to cyclophosphamide or anti-thymocyte globulin
    E.5 End points
    E.5.1Primary end point(s)
    SLE patients achieving complete clinical remission at Month 24 after autologous hematopoietic stem cell transplantation, defined as SLEDAI less than 3 in the absence of immunosuppressive therapy and prednisolone ≤ 5mg daily.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    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) Yes
    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.8.5The 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
    The trial will be finished with the last follow-up visit at Month 48.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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) No
    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 2008-03-11. 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    SLE-patients with cerebral manifestation may have a legal representative
    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.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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 Decision2008-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-24
    P. End of Trial
    P.End of Trial StatusOngoing
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