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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   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) .
     
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    Summary
    EudraCT Number:2006-003983-73
    Sponsor's Protocol Code Number:C-2006-009
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-03-23
    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 - BfArM
    A.2EudraCT number2006-003983-73
    A.3Full title of the trial
    A Phase IIa Multicenter, Randomized, Double-Blind, Placebo -Controlled, Parallel Group Study of RWJ-445380 Cathepsin-S Inhibitor in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy
    A.4.1Sponsor's protocol code numberC-2006-009
    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 SponsorJanssen-Cliag International N.V.
    B.1.3.4CountryBelgium
    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 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 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.3.1Product nameRWJ-445380 Capsules 50 mg
    D.3.2Product code RWJ-445380-002
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 400797-45-7
    D.3.9.2Current sponsor codeRWJ-445380-002
    D.3.9.3Other descriptive nameJNJ-16240159-AAC
    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 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) Information not present in EudraCT
    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 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.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 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.3.1Product nameRWJ-445380 capsule 100 mg
    D.3.2Product code RWJ-445380-002
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 400797-45-7
    D.3.9.2Current sponsor codeRWJ-445380-002
    D.3.9.3Other descriptive nameJNJ-16240159-AAC
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Information not present in EudraCT
    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 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.IMP: 3
    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.3.1Product nameRWJ-445380 capsules 150 mg
    D.3.2Product code RWJ-445380-002
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 400797-45-7
    D.3.9.2Current sponsor codeRWJ-445380-002
    D.3.9.3Other descriptive nameJNJ-16240159-AAC
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) Information not present in EudraCT
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rheumatoid arthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    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 tolerability of RWJ-445380 at doses of 100, 200, or 300 mg/day for up to 12 weeks in patients with active Rheumatoid Arthritis (RA) despite methotrexate (MTX) therapy.
    E.2.2Secondary objectives of the trial
    ·To evaluate the efficacy of RWJ-445380 in patients with active RA despite methotrexate therapy receiving doses of 100, 200, or 300 mg/day.

    ·To assess the effect of RWJ-445380 on various biomarkers associated with RA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients must have provided written consent to participate in the study prior to any study procedures and understand that they are free to withdraw from the study at any time.

    2. Patients must be able to read and understand the consent form, complete the study-related procedures, and communicate with the study staff.

    3. Patients may be men or women and must be 18 years or older. (For potential patients > 70 years of age, the investigator must confer with the Medical Monitor during screening to determine the patient’s medical suitability prior to enrollment.)

    4. Patient must have a diagnosis of Rheumatoid Arthritis Functional Class I-III according to the American College of Rheumatology (ACR) criteria for at least 6 months prior to Screening. (See Appendix 3).

    5. Patients must have active RA at the time of Screening and at baseline, as defined by eight or more swollen joints and eight or more tender joints.

    6. Patients must have started oral or parenteral MTX treatment, at least 10 mg/week, for a minimum of 6 months prior to Screening and must have a stable MTX dose for a minimum of 8 weeks prior to the first study drug dose.

    7. Patients must be on a stable dose of folic acid (1 to 5 mg) for at least 4 weeks prior to the first study drug dose.

    8. If using oral corticosteroids, patients must be on a stable dose equivalent to £ 10 mg of prednisone/day for at least 4 weeks prior to the first study dose. If currently not using corticosteroids, patients must have not received oral corticosteroids for at least 4 weeks prior to the first study dose.

    9. If using non-steroidal anti-inflammatory drugs (NSAIDs), patients must be on a stable dose for at least 4 weeks prior to the first study dose. If currently not using NSAIDs, the patient must not have received NSAIDs for at least 4 weeks prior to the first study dose.

    10. Patients must have Screening laboratory test result as follows:
    · Hemoglobin ³ 9.0 g/dL (International System of Units [SI]: ³ 90 g/L)
    · White blood cells (WBC) ³ 3.0 x 103 cells/μL (SI: ³ 3.0 x109 cells/L)
    · Neutrophils ³ 1.5 x 103 cells/mL (SI: ³ 1.5 x109 cells/L)
    · Platelets ³ 100 x 103 cells/mL (SI: ³ 100 x109 cells/L)
    · Transaminase level not exceeding 1.5 times the upper limit of normal (ULN) for the central laboratory conducting the test
    · Bilirubin level not exceeding 1.5 times the upper limit of normal (ULN) for the central laboratory conducting the test
    · Serum creatinine not exceeding 1.5 mg/dL (SI: £ 125 mmol/L)

    11. Patients must have a negative intradermal tuberculin skin test at Screening or within 1 month prior to study treatment initiation. Specific guidelines for administering and interpreting the TB skin test are provided in Appendix 10, along with provisions for enrolling patients with positive TB skin tests because of prior vaccination with BCG. For the purposes of this study, the criterion for PPD positivity generally applied for immunocompromised patients (induration > 5 mm) will be used.

    12. Patients must satisfy the following Screening criteria for TB:
    · No history of active or latent TB prior to Screening
    · Have no signs or symptoms suggestive of active TB upon medical history and/or
    physical examination
    · Have had no recent close contact with a person with active TB (if contact has
    occurred, has been referred to a physician for evaluation; evaluation should be
    documented and discussed with sponsor medical monitor, as appropriate).

    13. Patients must consent to utilize a medically acceptable and highly effective (< 1% failure rate) method of contraception throughout the entire study period from Screening through study termination.

    14. Are willing and able to adhere to the study visit schedule, and understand and comply with other protocol requirements.
    E.4Principal exclusion criteria
    1. Patients who are pregnant, nursing, or planning a pregnancy (both men and women) within 6 months of enrollment.

    2. Patients who have other inflammatory diseases that might confound the evaluations from RWJ-445380 therapy (including but not limited to ankylosing spondylitis, systemic lupus erythematosus, Lyme disease).

    3. Patients who have received disease-modifying anti-rheumatic drugs ([DMARDs] other than MTX (e.g., D penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold, azathioprine or sulphasalazine) or interleukin [IL]-1 receptor antagonist [anakinra] within 4 weeks prior to the first study dose, or leflunomide within 3 months of the first study dose.

    4. Patients who have been previously treated with more than one therapeutic agent targeted at reducing TNFa (including but not limited to infliximab, etanercept, adalimumab, CDP870 or thalidomide).

    5. Patients who have received prior anti-TNF treatment within 4 weeks prior to first study dose or received the anti-TNF infliximab within 3 months prior to the first study dose.

    6. Patients who have been treated with any p38 MAP kinase inhibitor, abatacept or rituximab.

    7. Patient who have used cytotoxic drugs, including chlorambucil, cyclophos-phamide, nitrogen mustard, or other alkylating agents.

    8. Patients who have previously received treatment with a Prosorba® column.

    9. Patients who have been treated with any anti-CD4 antibody.

    10. Patients who have received intra-articular, intramuscular, or IV cortico-steroids, including intramuscular adrenocorticotrophic hormone during the 4 weeks prior to the first study dose.

    11. Patients who have taken any investigational drug within the previous 30 days or within a period of 5 half-lives, whichever is greater, prior to first study dose.

    12. Patients who have received, or who are expected to receive, live virus or bacterial vaccinations within 1 month before first study drug dose, during the trial, or up to 1 month after the last study drug dose.

    13. Patients who have a history of infected joint prosthesis or have received antibiotics for a suspected infection of a joint prosthesis if that prosthesis has not been removed or replaced.

    14. Patients who have, or have had, a serious infection during the previous 2 months prior to first study treatment (including but not limited to hepatitis, pneumonia, or pyelonephritis, or have been hospitalized or received IV antibiotics for an infection.

    15. Patients who have a history of, ongoing chronic, or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection (eg, bronchiectasis), sinusitis, recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), an open, draining, or infected skin wound, or ulcer.

    16. Patients who have, or have history of an opportunistic infection (eg, herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, mycobacteria other than TB, or granulomatous infection).

    17. Patients with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.

    18.Patients with current signs or symptoms of clinically significant, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral disease.

    19. Patients with medical conditions associated with pruritus (dermatological or drug induced), current or within 6 months of screening.

    20. Patients with a resting heart rate less than 45 or greater than 100 beats per minute.

    21. Patients with sitting systolic blood pressure >160 mmHg or <90 mmHg, and/or a sitting diastolic blood pressure of >100 mmHg or <50 mmHg at screening.

    22. Patients with confirmed screening QTc interval > 450 msec or a history of additional risk factors for torsades de point (e.g., heart failure, hypokalemia, family history of long QT Syndrome) or the use of concomitant medications that prolong the QT/QTc interval.

    23. Patients who have a history of lymphoproliferative disease, including lymphoma, or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location, or clinically significant splenomegaly.

    24. Patients who have any known malignancy or have a history of malignancy within the previous 5 years (with the exception of a nonmelanoma skin cancer that has been treated with no evidence of recurrence).

    25. Patients who have a transplanted organ (with exception of a corneal transplant >3 months prior to Screening).

    26. Patients who have, or have history of a substance abuse (drug or alcohol) problem within the previous 3 years.

    27. Patients who are unable to undergo multiple venipunctures because of poor tolerability or lack of easy access.

    28. Patients who are participating in another investigational drug trial during participation in this trial.

    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is response to ACR20, but responses to ACR50 and ACR70 will also be evaluated. ACR(%) is a composite efficacy measure comprised of: swollen joint count, tender joint count, patient asseessment of pain (VAS), patient's global assessment of disease activity (VAS), evaluator's global assessment of disease activity (VAS), patients's assessment of physical function as measured by the HAQ and CRP.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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) No
    E.8.2.2Placebo Yes
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 study is considered complete with the last visit of the last patient.
    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 months0
    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 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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 162
    F.4.2.2In the whole clinical trial 240
    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 the trial, patients will return to their referring physician for regular care. Patients who have participated in this trial will not be excluded from the sponsor's longer term efficacy or open label trials which might take place in the future.
    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 Decision2007-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-03-10
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