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    Summary
    EudraCT Number:2012-004893-25
    Sponsor's Protocol Code Number:CRO2035
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-05-15
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-004893-25
    A.3Full title of the trial
    RITUXILUP - An open label randomised multicentre controlled trial of RITUXImab and mycophenolate mofetil (MMF) without oral steroids for the treatment of LUPus nephritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The treatment of Lupus nephritis with RITUXIMAB and mycophenolate mofetil (MMF) without oral steroids.
    A.3.2Name or abbreviated title of the trial where available
    RITUXILUP, Version 1.0
    A.4.1Sponsor's protocol code numberCRO2035
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN84054592
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01773616
    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 SponsorImperial College London
    B.1.3.4CountryUnited Kingdom
    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 supportArthritis Research UK
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    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 Rituximab (MabThera®/Rituxan®)
    D.2.1.1.2Name of the Marketing Authorisation holderF. HOFFMANN-LA ROCHE LTD
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 nameRituximab
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNRituximab
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.4EV Substance CodeAS4
    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 No
    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.IMP: 2
    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 Mycophenolate mofetil
    D.2.1.1.2Name of the Marketing Authorisation holderQualimed
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameMycophenolate mofetil
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMycophenolate mofetil
    D.3.9.1CAS number 128794-94-5
    D.3.9.3Other descriptive nameMMF
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500mg
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMycophenolate mofetil
    D.3.9.4EV Substance CodeAS2
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Prednisolone
    D.2.1.1.2Name of the Marketing Authorisation holderActavis UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namePrednisolone
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrednisolone
    D.3.9.1CAS number 50-25-8
    D.3.9.4EV Substance CodeAS5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 mg to 5 mg
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Lupus nephritis
    E.1.1.1Medical condition in easily understood language
    Lupus nephritis is a specific kind of kidney inflammation (called nephritis) that affects children and adults with systemic lupus erythematosus (SLE). SLE is an autoimmune condition.
    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 17.0
    E.1.2Level PT
    E.1.2Classification code 10025140
    E.1.2Term Lupus nephritis
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Based on published data, including our pilot data and the huge experience of the detrimental effects of steroids, we plan to test the hypothesis that in steroid naïve patients with a new flare of lupus nephritis, the addition of Rituximab to mycophenolate mofetil (MMF) but without oral steroids, is at least as effective at inducing a response as the standard of care therapy comprising MMF and oral steroids. Full details are given in A57.

    E.2.2Secondary objectives of the trial
    The clinical study aims to address the following questions:
    1. Is the combination of Rituximab and mycophenolate mofetil without oral steroids superior to mycophenolate mofetil and oral steroids with respect to safety as judged by:
    a) fewer serious infections
    b) fewer serious adverse events
    c) fewer metabolic abnormalities especially the new onset of diabetes, weight gain, bone thinning (osteoporosis) and, in children, reduced growth rate?
    2. Is the combination of Rituximab and mycophenolate mofetil without oral steroids non inferior to mycophenolate mofetil and oral steroids in bringing active lupus nephritis under control over time as judged by:
    a) the proportion of patients achieving partial renal response (PR) at week 52 (see A58 for definitions)
    b) the time to complete remission
    c) the time to partial remission
    d) the proportion of patients achieving partial remission who on repeat kidney biopsy have achieved a full histological remission i.e. no active disease on biopsy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adults aged 18-75 years old and children aged 12-17 years old with active lupus nephritis ISN/RPS Class III A or A/C, Class IV-G A or A/C, Class IV-S A or A/C, and / or Class V on kidney biopsy done within previous 8 weeks.
    2. Urine protein:creatinine ratio >100mg/mmol (>1mg/mg) at visit -1 or any time with 14 days before visit -1.
    3. No contraindications to the use of IV methyl prednisolone, mycophenolate mofetil, oral steroids or rituximab or any other required medications.
    4. Able to provide informed consent.
    5. Willingness to use a medically acceptable form of contraception (progesterone only pill, progesterone implants, oral contraceptive if not contraindicated, intrauterine contraceptive device, barrier methods) if female and at risk of pregnancy.
    E.4Principal exclusion criteria
    1) Aged <12 years or >75 years
    2) Obsolescence of >50% of the glomeruli or tubulointerstitial scarring of >50%
    3) Severe “critical” SLE flare defined as:
    a) BILAG 2004 A flare in CNS system
    b) or any SLE manifestation requiring more immunosuppression than allowed within the protocol in the physician's opinion
    4) Pregnancy
    5) Breast feeding
    6) Patients should not be on or require maintenance steroids and should not have had more than 4 weeks of steroids in the period immediately preceding recruitment irrespective of dose
    7) Patients that have had more than 1.5g of IV methyl prednisolone in the previous 4 weeks
    8) Prior use within 12 months of visit -1 of therapeutic monoclonal antibody, or B or T cell modulating ‘biologic’ use
    9) Prior use within 6 months of visit -1 of Intravenous immunoglobulin / plasma exchange
    OR Cyclophosphamide
    10) eGFR <30mls/min/1.73m2
    11) Active infections, including but not limited to the human immunodeficiency virus (HIV), and hepatitis B (including prior infection as judged by positive Hepatitis B core antibody) or Hepatitis C or tuberculosis
    12) Receipt of a live-attenuated vaccine within 3 months of study enrolment
    13) In the investigator’s opinion, patients that are at high risk for infection (including but not limited to indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent severe urinary tract infection)
    14) Prior history of invasive fungal infections
    15) History of any cancer
    16) In female patients, known history of cervical dysplasia CIN Grade III cervical high risk human papillomavirus or abnormal cervical cytology other than abnormal squamous cells of undetermined significance (ASCUS) within the past 3 years. The patient will be eligible after the condition has resolved (e.g., follow-up HPV test is negative or cervical abnormality has been effectively treated >1 year ago)
    17) Any concomitant medical condition that in the investigator’s opinion, or after discussion with the CI, places the participant at risk by participating in this study.
    18) Comorbidities requiring systemic corticosteroid therapy.
    19) Current substance abuse.
    20) IgG below lower limit of local laboratory range
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is to demonstrate non-inferiority in the proportion of patients achieving complete renal response (CR) at week 52 in Rituximab arm of the study compared with the Control arm.

    Where CR is defined as:
    - uPCR ≤50mg/mmol (=<0.5mg/mg) in a spot urine

    AND

    - eGFR ≥60ml/min, or if <60ml/min at screening, not fallen by >20% compared to screening/randomisation (whichever worse)

    AND

    - In the Rituximab arm without the need to prescribe oral steroids within 1 year, except for one course of oral prednisolone maximum 30mg for a maximum of 14 days OR one intramuscular, one intravenous injection or two intra-articular injections of steroids, each maximum 120mg methylprednisolone or equivalent (in addition to the planned IV methyl prednisolone in the protocol)

    OR

    - in the steroid arm without the need for additional steroids over and above the prescribed taper, except for one course of oral prednisolone maximum 30mg for a maximum of 14 days OR one intramuscular, one intravenous injection or two intra-articular injections of steroids, maximum 120mg methylprednisolone or equivalent (in addition to the planned IV methyl prednisolone in the protocol).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary outcome will be evaluated at 52 weeks.
    E.5.2Secondary end point(s)
    Secondary outcomes

    To explore if:

    Does steroid sparing reduce adverse events?:
    1. Proportion of patients with Serious Infectious Episodes
    2. Proportion of patients with Serious Adverse Events (AEs)
    3. Proportion of patients with evidence of metabolic abnormalities including:
    o New onset diabetes
    o Development of osteopenia or osteroporosis on bone density scan
    o Change in weight, BMI, waist /hip ratio
    o Paediatric – deviation from expected growth velocity

    Disease control over time:
    4. The proportion of patients achieving partial renal response (PR) at week 52 where PR is defined as:
    - eGFR - no more than a 20% decrease from the baseline value,
    AND
    - if not nephrotic at baseline (urine PCR <300mg/mmol (3mg/mg)), 50% improvement in spot urine PCR
    OR
    - if nephrotic at baseline (urine PCR >300mg/mmol (3mg/mg)), 50% improvement in spot urine PCR AND urine PCR <300mg/mmol
    5. Time to CR
    6. Time to PR where PR is defined as above.
    7. Proportion of patients in PR who achieve histological remission as judged by absence of proliferative lesions and no new subendothelial or subepithelial deposits on repeat biopsies
    8. Proportion of patients with renal flare where flare is identified by:
    proteinuria >50% increase
    AND
    above 100mg/mmol for 2 consecutive visits
    AND/OR
    - in those with normal renal function and normal urinary sediment, a fall of >20% in eGFR on 2 occasions
    - where possible flare should be proven by repeat renal biopsy.
    9. Cumulative steroid exposure (to include all oral and IV steroids from first dose of Rituximab)
    10. Deviation from the steroid taper in steroid arm and/or introduction of steroids in the steroid-free arm
    11. Proportion of patients achieving a response as defined by the SLE responder index (SRI) at week 52 and annually thereafter as defined by: a >4 point reduction in SELENA-SLEDAI score, no new BILAG A organ domain score and no more than I new BILAG B score and no worsening in physician’s global assessment (PGA) by >10% and must not have received non-protocol treatment.
    12.Proportion of patients achieving a response as defined by the BILAG-based Composite Lupus Assessment (BICLA) at week 52 and annually thereafter as defined by: BILAG-2004 improvement (BILAG A to B/C/D, BILAG B to C/D and no BILAG worsening, no deterioration in SLEDAI total score, no worsening in physician’s global assessment (PGA) by >10% and must not have received non-protocol treatment.
    13. An important exploratory outcome will be to evaluate whether removing oral steroids from the treatment of lupus nephritis improves quality of life for patients? This will be assessed using adult quality of life measures including LUPUSQoL, SF-36, EQ5D and for children the SMILEY measure.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time points are at 1, 2 and where available 3 and 4 years and along the way for “time to” end points. All patients will be followed for a minimum of 2 years but patients entered early will be offered follow up until the last patient recruited has reached the 2 year time point i.e. up to a maximum of 4 years.
    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 Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    Oral steroids
    E.8.2.4Number of treatment arms in the trial2
    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 concerned29
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Canada
    Russian Federation
    United Arab Emirates
    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
    Recruitment is predicted to take 2 years and minimum follow up is for 2 years so 4 years from first patient recruited.
    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 months11
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 26
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 26
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 216
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state189
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 212
    F.4.2.2In the whole clinical trial 252
    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)
    Treatment would be recommended as per local standard of care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Karolinska Institute
    G.4.3.4Network Country Switzerland
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-12-13
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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