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    The EU Clinical Trials Register currently displays   41189   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    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:2011-002067-20
    Sponsor's Protocol Code Number:RA0077
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-21
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2011-002067-20
    A.3Full title of the trial
    A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.
    A.3.2Name or abbreviated title of the trial where available
    -
    A.4.1Sponsor's protocol code numberRA0077
    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 SponsorUCB Pharma SA
    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 supportUCB Pharma SA
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointCT Registries & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim am Rhein
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number+492173481515
    B.5.5Fax number+492173481572
    B.5.6E-mailclinicaltrials@ucb.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 Yes
    D.2.1.1.1Trade name Cimzia
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma SA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCertolizumab pegol
    D.3.2Product code CDP870
    D.3.4Pharmaceutical form Solution for injection
    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 INNCERTOLIZUMAB PEGOL
    D.3.9.1CAS number 428863-50-7
    D.3.9.2Current sponsor codeCDP870
    D.3.9.4EV Substance CodeSUB25423
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Yes
    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 Humira
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAdalimumab
    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 INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe rheumatoid arthritis
    E.1.1.1Medical condition in easily understood language
    Rheumatoid arthritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10003268
    E.1.2Term Arthritis rheumatoid
    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 primary objectives of this study in adult subjects with moderate to severe RA responding inadequately to MTX are as follows:
    • To demonstrate the superiority of short term (Week 12) treatment in CZP+MTX randomized subjects as compared with ADA+MTX randomized subjects
    • To demonstrate the superiority of long term (Week 104) treatment in CZP+MTX randomized subjects as compared with ADA+MTX randomized subjects, with subjects who switch treatment (Week 12 Non Responders) counted as treatment failures.
    E.2.2Secondary objectives of the trial
    • To investigate whether a Week 12 decision point is better at predicting the long term (Week 104) treatment success with CZP+MTX as compared with a Week 12 decision point with ADA+MTX
    • To compare the percentage of subjects who meet ACR20 criteria at Week 6 between the CZP+MTX- and ADA+MTX randomized arms
    • To compare the percentage of subjects with DAS28(ESR) LDA at Week 6 between the CZP+MTX- and ADA+MTX randomized arms
    • To compare the percentage of subjects with DAS28(ESR) LDA at Week 12 between the CZP+MTX- and ADA+MTX randomized arms
    • To evaluate the percentage of subjects reaching DAS28(ESR) LDA at Week 104 in subjects responding (in accordance with the Week 12 Responder definition) at both Week 6 and Week 12 when treated with CZP+MTX compared with ADA+MTX
    • To evaluate the efficacy of CZP+MTX versus ADA+MTX in the physical function of Week 12 Responders at Week 104
    • To evaluate the time to discontinuation in Week 12 Responders treated with CZP+MTX versus ADA+MTX
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Subjects will be given the option to participate in a genetics, genomics, and proteomics sub-study. Subjects who decide to participate in the sub-study must complete a separate Informed Consent Form for Pharmacogenomics and Pharmacogenetics at Screening following the same procedure and given the same considerations as the main Informed Consent Form. Each subject’s willingness to participate in the sub-study will be independent from his/her consent to participate in the main study.
    E.3Principal inclusion criteria
    1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject.
    2. Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule or medication intake according to the judgment of the Investigator.
    3. Subject is ≥18 years of age at Screening.
    4. Subject must have a diagnosis of RA at Screening, as defined by the 2010 EULAR/ACR classification criteria (Aletaha D et al, 2010).
    5. Subject must have a positive rheumatoid factor (RF) and/or a positive anti cyclic citrullinated peptide antibody (anti-CCP) as determined by the central laboratory at Screening.
    6. Subject must have moderate to severe RA disease at Screening and Baseline defined as:
    a) Screening (all criteria required):
    • ≥4 swollen joints (of 28 prespecified joints).
    • DAS28(ESR) >3.2.
    • CRP concentration ≥10mg/L (or 1.0mg/dL) and/or ESR (Westergren) ≥28mm/hr.
    b) Baseline (both criteria required):
    • ≥4 swollen joints (of 28 prespecified joints).
    • DAS28(ESR) >3.2.
    7. Subject is considered by the Investigator to be responding inadequately to treatment with MTX. And inadequate response to MTX is based on the opinion of the Investigator and following a minimum 12-week course of MTX therapy prior to the Screening Visit.
    8. Subject is using MTX 15 to 25mg/week orally or subcutaneously at Screening and has used the same MTX regimen (dose and route) for a minimum of 28 days prior to baseline.
    9. If using oral corticosteroids at Baseline, the subject is using a stable dose of ≤10mg (unchanged for at least 28 days prior to Baseline). However, when deemed clinically necessary, one dose adjustment of no more than ±2.5mg during the 28 days prior to Baseline is acceptable provided the total dose does not exceed 10mg.
    10. The subject, if female, must be either postmenopausal for at least 1 year, surgically sterile, or practicing an acceptable method of contraception, such as: a) oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide) b) subjects must agree to use adequate forms of contraception from Screening through at least 10 weeks (or longer if required by local regulations as reflected by local product labelling) after the final dose of IMP. c)Male subjects must agree to ensure they or their female partner(s) use adequate contraception from Screening through at least 10 weeks (or longer if required by local regulations as reflected by local product labelling) after the final dose of IMP. Note: Abstinence is not an acceptable method of contraception; therefore, subjects engagin or intending to engage in sexual activity must agree to employ one of the aforementioned acceptable methods of contraception.
    11. Subject must have completed the Washout Periods for analgesics and nonbiologic DMARDs (except MTX) in accordance with Table 6.1 of the
    protocol.
    E.4Principal exclusion criteria
    1.Subject (sbj) has previously participated in this study (except when
    rescreening criteria apply) or sbj has received treatment with
    any biologic DMARD or has received treatment with cyclophosphamide,chlorambucil,Janus
    kinase,spleen tyrosine kinase or phosphodiesterase 4 inhibitors or investigational agents such as spleen tyrosine kinase.
    2.Sbj was randomized in another study of medication or a med. device within the previous 3 months or is currently participating in another study of a medication or med. device under investigation.
    [Criterion 3-4-5-6: please refer to the protocol - not modified by this amendment]. 7.Sbj must not have a diagnosis of any other inflammatory arthritis (eg psoriatic arthritis or ankylosing spondylitis or systemic lupus erythematosus/lupus nephritis) or have a Steinbrocker IV functional capacity. Sbj with Sjogren's Syndrome, as assessed by the PI to be limited to mild or moderate sicca symptoms that are considered to be a manifestation of secondary Sjogren's Syndrome related to RA, may be enrolled. However, systemic manifestation attributable to primary Sjogren's Syndrome are still considered exclusionary.
    8.Sbj must not have received any experimental biological or nonbiological therapy for immuno inflammatory indications.
    9.The subject may not use prohibited medications and may only use (if needed) medications within protocol defined limitations as outlined in IC 11 and Table 6.1.
    10.Sbj with active malignancy or a history of cancer.Exceptions are subjects with: no more than 2 basal cell carcinomas excised prior to study entry - cervical carcinoma in situ successfully surgically treated more than 5 yrs prior to Screening.
    11.Sbj with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease.
    12.Sbj with a history of blood dyscrasias.
    13.Sbj with a recent history or existing condition, as determined by the PI, of severe,progressive,and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease or other significant
    immunological/inflammatory disease including but not limited to inflammatory bowel disease.
    [Criterion 14-15-16-17-18-19: please refer to the protocol - not modified by this amendment].
    20.Sbj with a history or active systemic/respiratory infection due to fungal, parasitic, or mycotic pathogens including but not limited to histoplasmosis, coccidiosis, paracoccidiosis, pneumocystis, blastomyces, aspergillus and nontuberculus mycobacteria. Radiographic findings suggestive of infections such as apical fibrosis, pleural thickening, pulmonary nodules (including any pulmonary nodules of unspecified significance), fibrotic scars, calcified granulomas, upper lobe infiltrates, cavitations and pleural effusions, calcified lung nodules, calcified hilar lymph nodes, and pericardial calcification or any other finding that could be suggestive of inactive TB or active TB, are sufficient grounds for exclusion. Radiographs will be assessed by a radiologist whose review of the radiograph includes a deliberate assessment of the presence or absence of TB infection, granulomatous disease, etc. Any abnormal radiographic findings should be discussed with the Sponsor and/or Medical Monitor prior to subject enrollment.
    21.Sbj with a history of chronic or recurrent infections such as:- more than 3 episodes requiring antibiotics or antivirals during the preceding 6 months) or - recent serious or life threatening infection within the 12 months prior to the Baseline Visit (including Herpes zoster) or - hospitalization for any infection in the previous 6 months or - any sign or symptom that may indicate an infection.
    22.Sbj at a high risk of infection (eg sbj has leg ulcers, indwelling urinary catheter, or persistent or recurrent chest infections;or sbj who is permanently bedridden or wheelchair bound).
    23.Sbj with concurrent acute or chronic viral Hepatitis B or C infection including a positive test for any of the following are exclusionary: - Hepatitis B core antibody; -Hepatitis B surface antigen; -Hepatitis C antibody.
    24.Sbj with known human immunodeficiency virus infection.
    25.Sbj receiving live or attenuated vaccination during the 8 weeks (56 days) prior to Baseline. Live or attenuated vaccines are not permitted to be administered concurrently with CZP or ADA during the study.
    26.Sbj with known TB infection, at high risk of acquiring TB infection, or latent TB infection are exclusionary, as defined in the Protocol.
    27.Subject must not have been exposed to more than 4 different nonbiological DMARDs over their lifetime.
    28.Sbj has a positive urine drug screen at the Screening Visit for marijuana and its metabolites, controlled substances that are not legally prescribed for the subject, and/or illegal substances.
    E.5 End points
    E.5.1Primary end point(s)
    1) Percentage of subjects meeting ACR20 criteria [American College of Rheumatology 20% criteria] in the CZP+MTX randomized group compared with the ADA+MTX randomized group;
    2) Percentage of subjects with DAS28(ESR) LDA [Disease Activity Score-28 joint count(erythrocyte sedimentation rate) Low disease activity] in the CZP+MTX randomized group compared with the ADA+MTX randomized group (Group A versus Group C using all randomized subjects in the FAS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Week 12
    2) Week 104
    E.5.2Secondary end point(s)
    Among the others:
    1) The percentage of subjects with DAS28(ESR) LDA at Week 104 comparing the Week 12 Responder groups (Group A versus Group C).
    2) The percentage of subjects with DAS28(ESR) LDA at Week 6 using all subjects, comparing the CZP+MTX randomized arm and the ADA+MTX randomized arm
    3) The percentage of subjects with DAS28(ESR) LDA at Week 12 using all subjects, comparing randomized treatment groups CZP+MTX and ADA+MTX
    4) The percentage of subjects with DAS28(ESR) LDA at Week 104 comparing the Week 12 Responder groups (Group A versus Group C), who also responded at Week 6 (ie, DAS28(ESR) ≤3.2 or a DAS28(ESR) CFB reduction of ≥1.2)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Week 104
    2) Week 6
    3) Week 12
    4) Week 104
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    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 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 EEA96
    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
    Australia
    Canada
    Mexico
    Switzerland
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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: 446
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 446
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 383
    F.4.2.2In the whole clinical trial 892
    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)
    standard care
    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 Decision2012-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-01-13
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