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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42568   clinical trials with a EudraCT protocol, of which   7009   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-000443-33
    Sponsor's Protocol Code Number:CHS-0214-02
    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:2014-06-26
    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 number2014-000443-33
    A.3Full title of the trial
    A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel® in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate (CHS-0214-02)(RApsody)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Coherus RA Study
    A.3.2Name or abbreviated title of the trial where available
    ETA 302
    A.4.1Sponsor's protocol code numberCHS-0214-02
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02115750
    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 SponsorCoherus BioSciences, Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDaiichi Sankyo Company Ltd
    B.4.2CountryJapan
    B.4.1Name of organisation providing supportCoherus BioSciences Inc
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportBaxter (Baxter International, Inc., Baxter Healthcare Corporation, Baxter Healthcare SA)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace UK
    B.5.2Functional name of contact pointDirector of Regulatory Submissions
    B.5.3 Address:
    B.5.3.1Street Address1st Floor, 26-28 Hammersmith Grove
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW6 7HA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00447825587853
    B.5.5Fax number00442087416496
    B.5.6E-mailb.mcdougall@medpace.com
    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 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.3.2Product code CHS-0214
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEtanercept
    D.3.9.2Current sponsor codeCHS-0214
    D.3.9.3Other descriptive nameCHS-0214
    D.3.9.4EV Substance CodeSUB166284
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 Enbrel
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer 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 nameEtanercept
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNETANERCEPT
    D.3.9.1CAS number 185243-69-0
    D.3.9.4EV Substance CodeSUB01984MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.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
    Rheumatoid arthritis
    E.1.1.1Medical condition in easily understood language
    Rheumatoid arthritis
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10042952
    E.1.2Term Systemic rheumatoid arthritis
    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
    The objectives of Part 1 of the study are to compare the efficacy and safety of CHS 0214 manufactured in the EU, to Enbrel (EU) at 24 weeks in subjects with RA who have an inadequate response to methotrexate and no more than 3 other non-biologic disease modifying anti rheumatic drugs and who are naïve to biologic therapies.
    The objectives of Part 2 of the study are to evaluate the longer term safety and the durability of response to open-label CHS 0214.


    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet the following criteria to be enrolled in Part 1 of the study:
    1.Male or female adult ≥ 18 years of age (≥ 20 years of age in Japan);
    2.Have a diagnosis of RA, as defined by the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 or 1987 criteria for RA with disease duration of at least 6 months prior to Screening;
    3.Have had an adequate trial of MTX defined as having been on MTX for at least 3 months and on a stable, dose (≥ 8 mg/week to ≤ 25 mg/week, not to exceed local approved dose level) for at least 6 weeks prior to Screening;
    4.Have active disease, defined as: ≥ 6 tender joints, ≥ 6 swollen joints (based on 66 swollen joint count (SJC) and 68 tender joint count (TJC) )
    5. DAS28-CRP[4] ≥ 3.2 ;
    6.Have had an IR to MTX and may have failed no more than 3 other conventional non-biologic DMARDs (eg, hydroxychloroquine, oral or injectable gold, azathioprine, D penicillamine, sulfasalazine, and leflunomide or approved kinase inhibitors), and are candidates for tumor necrosis factor alpha (TNF α) inhibitor therapy;
    7.Have discontinued treatment with all DMARDs, except MTX, at least 2 weeks prior to Screening, For subjects taking leflunomide, cholestyramine should be administered 2 weeks prior to Screening to accelerate elimination of leflunomide as described in the approved label;
    8.Women who meet one of the following:
    a.Women of childbearing potential with a negative urine pregnancy test at Screening who agree to use one or more approved methods of birth control during the study. Approved methods of birth control are: hormonal contraception, intrauterine device, diaphragm plus spermicide, condom plus spermicide. Abstinence from heterosexual intercourse will be acceptable only if it is the preferred and usual lifestyle of the subject regardless of study participation; abstinence should be practiced for the duration of the study (study duration includes the Follow-up Visit) after taking the last dose of
    study drug;
    b.Women who have been postmenopausal for at least 2 years (with amenorrhea for at least 1 year) or have had a hysterectomy, bilateral salpingo-oophorectomy, or tubal ligation prior to signing the informed consent; and
    9.Able and willing to give written informed consent prior to performance of any study related procedures.

    Part 2: Subjects must meet the following criteria to be enrolled in Part 2 of the study:
    1.Completed the evaluations and achieved at least an ACR20 response at Week 24;
    2.Tolerated study drug in Part 1 with no SAEs or unresolved Grade 3 or higher adverse events related to study drug.
    E.4Principal exclusion criteria
    1.Use of parenteral glucocorticoids within 4W prior to initiation of Screening or use of intra-articular-glucocorticoids within 4W prior to randomization
    2.Use of oral glucocorticoids (such as > 10 mg prednisone per day (or equivalent corticosteroid), or a change in dosage within 2W prior to initiation of Screening (Note: the dose of prednisone ≤ 10 mg per day [or equivalent corticosteroid] should remain stable throughout Screening and should be expected to remain stable during the study for the subject to be eligible)
    3.Use of more than 1 NSAID or use of a single NSAID at greater than the recommended daily dose for that NSAID
    4.Prior treatment with any biologic for any indication (including but not limited to: tocilizumab [RoACTEMRA, Actemra], certolizumab pegol [CIMZIA], etanercept [Enbrel], adalimumab [HUMIRA], anakinra [Kineret], abatacept [ORENCIA], infliximab [REMICADE], rituximab [MabThera, Rituxan], and golimumab [SIMPONI]); (Note: insulin for diabetes mellitus and hormonal replacement therapy and hormonal birth control are allowed)
    5. Administration of a live vaccine within 4W prior to screening
    6.Participation in an investigational drug or device trial within 30D prior to randomization or a period equal to 5 times the half-life of the investigational agent, whichever is longer
    7.Functional class IV RA according to ACR revised classification, 1991, ie, limited ability to perform usual self care, vocational, and avocational activities
    8.Diagnosis of other rheumatic disease, autoimmune disease, connective tissue disease, or immune deficiency disease (eg, psoriasis, psoriatic arthritis, primary Sjögren’s syndrome, systemic lupus erythematosus, or demyelinating diseases such as multiple sclerosis)
    9.History of alcohol or drug abuse within 2Y prior to Screening
    10.White blood cell count < 3500 cells/mm3, lymphocyte count < 1000 cells/mm3, platelet count ≤ 125,000 cells/mm3, serum creatinine ≥ 2 mg/dL (177 µmol/L), alanine transaminase or aspartate transaminase ≥ 2.0 × the upper limit of normal of the reference range, or hemoglobin ≤ 8.5 g/dL at Screening
    11.Presence or history of malignancy (except for successfully treated non metastatic basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix)
    12.Presence of TB based on positive blood test (QuantiFERON®-TB Gold Test for TB) during Screening or subjects with known recent exposure to patient with active TB; Note: QuantiFERON®-TB Gold test can be repeated one time using a fresh sample in patients with an indeterminate result or low positivity defined as Quantiferon TB Antigen minus Nil value = 0.35-2 IU/mL. If the repeat test is negative, the subject may participate in the study. If the repeat test is positive or indeterminate, the subject does not qualify to participate in the study;
    13.Abnormal chest x-ray obtained within 6M prior to randomization demonstrating active lung disease processes other than RA (eg, evidence of TB or another active disease process). If a chest x-ray has not been obtained within the past 6M one should be obtained during the Screening process
    14.History of positive test results for fungal or other infections (e.g., histoplasmosis, coccidiomycosis) required by regional guidelines prior to start of biologic drugs within 3M prior to randomization
    15.Major systemic infections (eg, positive for hepatitisB surface antigen [HBsAg], hepatitisB core antibody [HBcAb], hepatitisC virus [HCV], or human immunodeficiency virus [HIV]);
    16.Class III or IV congestive heart failure as defined by the New York Heart Association criteria
    17.Presence of significant comorbid medical condition(s), including, but not limited to:
    a.uncontrolled diabetes mellitus (hemoglogin A1c [HgbA1c] ≥ 8% within the 3M prior to screening or history of diabetic ketoacidosis or hypoglycemic reactions requiring hospitalization within the 12 M prior to screening)
    b.uncontrolled hypertension (systolic blood pressure >160 mmHg and diastolic blood pressure >100 mmHg) within the 3M prior to screening
    c.severe kidney disease requiring hemodialysis or peritoneal dialysis
    d.advanced liver disease such as hepatitis or liver cirrhosis
    e.severe congestive heart failure or history of ejection fraction ≤ 30%
    f.severe lung disease requiring home oxygen or
    g.active unstable angina req. daily treatment with nitrates or other medications or
    18.Presence of any other major medical or psychiatric illness that in the opinion of the PI would put the subj at increased risk or affect the ability to participate in the study
    19.Known or suspected sensitivity or allergic reactions to latex or latex-containing products or product excipients
    20.History of MTX associated clinically significant toxicity such as interstitial lung disease or persistently elevated transaminases or
    21.Women who are pregnant or nursing.
    22. Men whose partners may become pregnant (do not agree to use contraception or who are not post-menopausal)
    E.5 End points
    E.5.1Primary end point(s)
    1. The primary efficacy endpoint in Part 1 will be the percentage of subjects who achieve 20% improvement according to American College of Rheumatology Criteria (ACR20) at Week 24 compared to Baseline (week0/day0). Subjects will be considered an ACR20 responder if: compared to Baseline (week0/Day 0), they achieve: 20% decrease in swollen joint counts (SJC), 20% decrease in tender joint counts (TJC), and 20% improvement in 3 of the following 5 measures
    • Hs-CRP;
    • Health Assessment Questionnaire – Disability Index (HAQ DI);
    • Subjects pain assessment using a visual analoguie scale (VAS);
    • Subject global assessment of disease activity (SGA);
    • Physicians global assessment of disease activity (PGA).

    2.The primary response duration endpoint will be the percentage of subjects who maintain ACR20 response from week 24 (durable effect) or who have a continued improvement in response (ACR50 response, ACR70 response) and DAS28-CRP(4) to < 3.2(low disease activity) and < 2.6 (remission) assessed at weeks 28. 36 and 48
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. From baseline - Day 0 to week 24
    2. Part 1 - weeks 0, 4, 8, 12, 18, and 24 and for Part 2 - weeks 28, 36, and 48.

    E.5.2Secondary end point(s)
    The secondary efficacy variables will include
    1. ACR20 at Weeks 4, 8, 12, and 18;
    2. The average percent improvement from Baseline (Week0/Day 0) in individual ACR response criteria: TJC, SJC, HAQ-DI;
    3. Subject’s pain assessment (subject’s pain-VAS), SGA, PGA and hs-CRP at Weeks 4, 8, 12, 18 and 24;
    4. 50% and 70% improvement according to American College of Rheumatology criteria (ACR50 and ACR70, respectively) and DAS28-CRP(4) < 3.2. ;
    5. Remission rate (defined as DAS28 CRP(4) < 2.6 on all subsequent visits after DAS28 CRP(4) < 2.6 is achieved).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Weeks 4, 8, 12 and 18
    2. From Basline
    3. Weeks 4, 8, 12, 18, and 24
    4. Weeks 4, 8, 12, 18, and 24
    5. At all subsequent study visists after required DAS28 CRP(4) is reached
    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 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 No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    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
    Belarus
    France
    Germany
    Hungary
    Israel
    Italy
    Japan
    Poland
    Russian Federation
    South Africa
    Spain
    Ukraine
    United Kingdom
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 414
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 206
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 620
    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)
    The sponsor expect to conduct an open label safety extension study for subjects who complete Part 2 of the study
    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 Decision2014-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-27
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