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   41232   clinical trials with a EudraCT protocol, of which   6757   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

    Download PDF

    Clinical Trial Results:
    A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

    Summary
    EudraCT number
    2012-005026-30
    Trial protocol
    HU   LT   CZ   BG   PL  
    Global end of trial date
    28 Nov 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    07 Feb 2019
    First version publication date
    07 Feb 2019
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    SB4-G31-RA
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Samsung Bioepis Co., Ltd.
    Sponsor organisation address
    107, Cheomdan-daero, Incheon, Korea, Republic of,
    Public contact
    Quintiles Contact Centre, Quintiles Limited, +1 862261 3634,
    Scientific contact
    Quintiles Contact Centre, Quintiles Limited, +1 862261 3634,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Nov 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to demonstrate the equivalence of SB4 to Enbrel® at Week 24, in terms of American College of Rheumatology 20% response criteria (ACR 20) response rate in subjects with moderate to severe rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.
    Protection of trial subjects
    The study and clinical study protocols were reviewed and approved by Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for each study centre. This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki (2008) and that are consistent with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines (ICH E6) and applicable local regulatory requirements and laws. The nature and purpose of the study was fully explained to each subject and written informed consent was obtained at Screening from each subject before any study related procedures were performed. The consent documents for the study was reviewed and approved by the appropriate IEC or IRB prior to use.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    12 May 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Ukraine: 121
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Bulgaria: 50
    Country: Number of subjects enrolled
    Colombia: 8
    Country: Number of subjects enrolled
    Czech Republic: 92
    Country: Number of subjects enrolled
    Hungary: 10
    Country: Number of subjects enrolled
    Korea, Republic of: 23
    Country: Number of subjects enrolled
    Lithuania: 53
    Country: Number of subjects enrolled
    Mexico: 21
    Country: Number of subjects enrolled
    Poland: 217
    Worldwide total number of subjects
    596
    EEA total number of subjects
    423
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    515
    From 65 to 84 years
    81
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Participants who fulfilled the inclusion/exclusion criteria were randomly assigned to 1 of the 2 treatments of this study.

    Pre-assignment period milestones
    Number of subjects started
    777 [1]
    Number of subjects completed
    596

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Screening failure: 181
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: the Sponsor used data from 'Enrolled Set', not 'Randomised Set' to fill in 'Pre-assignment period' and 'Enrolled Set' was consisted of all subjects who provided informed consent for this study. Screened(Pre-assignment) subjects: 747, Randomised subjects: 544.
    Period 1
    Period 1 title
    Randomised, Double-blind Period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    SB4 (proposed etanercept biosimilar)
    Arm description
     Presentation: prefilled syringe  Dose regimen: 50 mg once weekly  Mode of administration: subcutaneous injection
    Arm type
    Experimental

    Investigational medicinal product name
    etanercept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dose regimen: 50 mg once weekly Mode of administration: subcutaneous injection

    Arm title
    Enbrel
    Arm description
     Presentation: prefilled syringe  Dose regimen: 50 mg once weekly  Mode of administration: subcutaneous injection
    Arm type
    Active comparator

    Investigational medicinal product name
    etanercept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dose regimen: 50 mg once weekly Mode of administration: subcutaneous injection

    Number of subjects in period 1
    SB4 (proposed etanercept biosimilar) Enbrel
    Started
    299
    297
    Completed
    259
    246
    Not completed
    40
    51
         Protocol deviation
    1
    -
         Physician decision
    15
    10
         Lack of efficacy
    1
    3
         Adverse event, serious fatal
    2
    -
         Adverse event, non-fatal
    11
    17
         Consent withdrawn by subject
    9
    18
         Lost to follow-up
    1
    3

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    SB4 (proposed etanercept biosimilar)
    Reporting group description
     Presentation: prefilled syringe  Dose regimen: 50 mg once weekly  Mode of administration: subcutaneous injection

    Reporting group title
    Enbrel
    Reporting group description
     Presentation: prefilled syringe  Dose regimen: 50 mg once weekly  Mode of administration: subcutaneous injection

    Reporting group values
    SB4 (proposed etanercept biosimilar) Enbrel Total
    Number of subjects
    299 297 596
    Age categorical
    Units: Subjects
        Less than 65 years
    253 262 515
        65 years or over
    46 35 81
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    52.1 ± 11.72 51.6 ± 11.63 -
    Gender categorical
    Units: Subjects
        Female
    249 253 502
        Male
    50 44 94

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    SB4 (proposed etanercept biosimilar)
    Reporting group description
     Presentation: prefilled syringe  Dose regimen: 50 mg once weekly  Mode of administration: subcutaneous injection

    Reporting group title
    Enbrel
    Reporting group description
     Presentation: prefilled syringe  Dose regimen: 50 mg once weekly  Mode of administration: subcutaneous injection

    Subject analysis set title
    Per-protocol set 1
    Subject analysis set type
    Per protocol
    Subject analysis set description
    consists of all FAS subjects who complete the Week 24 visit and have an adherence(through Week 24) within the range 80–120% of both the expected number of IP injections and the expected sum of MTX doses without any major protocol deviations that affect the efficacy assessment.

    Subject analysis set title
    Per-protocol set 2
    Subject analysis set type
    Per protocol
    Subject analysis set description
    consisted of all FAS subjects who completed the Week 52 visit and had an adherence (from baseline to Week 52) within the range 80-120% of both the expected number of IP injections and the expected sum of MTX doses without any major PDs that affected the efficacy assessment.

    Primary: ACR20 Response Rate at Week 24

    Close Top of page
    End point title
    ACR20 Response Rate at Week 24
    End point description
    End point type
    Primary
    End point timeframe
    At week 24
    End point values
    SB4 (proposed etanercept biosimilar) Enbrel Per-protocol set 1
    Number of subjects analysed
    247
    236
    483
    Units: number of subjects
        nymber ofsubjects achieving ACR20 response at Week
    193
    190
    383
    Statistical analysis title
    Equivalence test
    Comparison groups
    SB4 (proposed etanercept biosimilar) v Enbrel
    Number of subjects included in analysis
    483
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    Method
    Parameter type
    Adjusted
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.15
         upper limit
    0.15

    Secondary: ACR20 Response Rate at Week 52

    Close Top of page
    End point title
    ACR20 Response Rate at Week 52
    End point description
    End point type
    Secondary
    End point timeframe
    At Seek 52
    End point values
    SB4 (proposed etanercept biosimilar) Enbrel Per-protocol set 2
    Number of subjects analysed
    224
    216
    440
    Units: number of subejcts achieving ACR20 respo
        Number of subejcts achieving ACR20 response
    181
    176
    357
    Statistical analysis title
    Equivalence test
    Comparison groups
    SB4 (proposed etanercept biosimilar) v Enbrel
    Number of subjects included in analysis
    440
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    Method
    Parameter type
    Adjusted
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.15
         upper limit
    0.15

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    an onset date on or after the date of first dose of IP until the Follow-up Visit.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    SB4 (proposed etanercept biosimilar)
    Reporting group description
    Safety Set: consisted of all subjects who received at least one dose of double-blind IP during the study phase

    Reporting group title
    Enbrel
    Reporting group description
    Safety Set: consisted of all subjects who received at least one dose of double-blind IP during the study phase

    Serious adverse events
    SB4 (proposed etanercept biosimilar) Enbrel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 299 (6.02%)
    15 / 297 (5.05%)
         number of deaths (all causes)
    2
    0
         number of deaths resulting from adverse events
    2
    0
    Vascular disorders
    HYPERTENSIVE CRISIS
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    ADENOCARCINOMA GASTRIC
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    BREAST CANCER
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUNG CANCER METASTATIC
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INVASIVE DUCTAL BREAST CARCINOMA
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    DEVICE FAILURE
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    OVARIAN CYST
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UTERINE POLYP
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VAGINAL PROLAPSE
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    FEMORAL NECK FRACTURE
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    ACUTE MYOCARDIAL INFARCTION
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIAL FIBRILLATION
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIOPULMONARY FAILURE
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    CORONARY ARTERY DISEASE
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    NEUTROPENIA
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    SYNCOPE
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    CHORIORETINOPATHY
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ENTEROCOLITIS
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTRITIS
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    BILE DUCT STONE
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHOLANGITIS
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHOLECYSTITIS
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHOLELITHIASIS
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GALLBLADDER PERFORATION
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    PSORIASIS
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    RHEUMATOID ARTHRITIS
         subjects affected / exposed
    1 / 299 (0.33%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STILL'S DISEASE ADULT ONSET
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    LIVER ABSCESS
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERITONITIS
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    APPENDICITIS
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CELLULITIS
         subjects affected / exposed
    0 / 299 (0.00%)
    2 / 297 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ERYSIPELAS
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    SB4 (proposed etanercept biosimilar) Enbrel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    60 / 299 (20.07%)
    70 / 297 (23.57%)
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    18 / 299 (6.02%)
    17 / 297 (5.72%)
         occurrences all number
    25
    26
    General disorders and administration site conditions
    INJECTION SITE ERYTHEMA
         subjects affected / exposed
    6 / 299 (2.01%)
    33 / 297 (11.11%)
         occurrences all number
    16
    85
    Infections and infestations
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    24 / 299 (8.03%)
    16 / 297 (5.39%)
         occurrences all number
    28
    18
    NASOPHARYNGITIS
         subjects affected / exposed
    15 / 299 (5.02%)
    16 / 297 (5.39%)
         occurrences all number
    17
    17

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Dec 2012
    • Screening period was increased to 6 weeks. • Washout period was removed. • Potential benefits and risks of SB4 were added. • Additional example for subject withdrawal was added. • The number of permitted use of intra-articular injections was limited to 2. • The number of subjects being unblinded during the study was limited. • The DAS28 score calculation equation was changed. • The use of corticosteroid for prevention or treatment of any condition other than RA was allowed. • Questionnaires (subject pain assessment VAS, subject global assessment VAS, physician global assessment VAS, HAQ-DI) were replaced with different versions. • The method to assess the expectedness of an AE was added. • The condition as to when hospitalisation should be considered SAE was clarified. • Analysis sets were clarified. • Administrative changes were implemented, which included changes in the composition of the DSMB and changes in the address and contact information for Sponsor and study staff. • Clarifications and editorial changes were made throughout the protocol, as appropriate.
    15 Mar 2013
    • Administrative changes were implemented. • Clarifications and editorial changes were made throughout the protocol, as appropriate. • Duration of morning stiffness was removed from listing of continuous variables for consistency with the study design.
    12 Mar 2014
    • Coordinating Investigator for the study was designated. • Editorial changes were made for clarification throughout the protocol, as appropriate

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    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