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    Summary
    EudraCT Number:2011-005090-22
    Sponsor's Protocol Code Number:001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-01-17
    Trial 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 number2011-005090-22
    A.3Full title of the trial
    A study of efficacy and safety of delayed release prednisone in newly diagnosed cases of Giant Cell Arteritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of the effectiveness and safety of delayed release prednisone in patients with newly diagnosed Giant Cell Arteritis
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and safety of delayed release prednisone in GCA
    A.4.1Sponsor's protocol code number001
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN40911426
    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 SponsorSouthend Hospital
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNapp Pharmaceutical Group
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSouthend University Hospital NHS Foundation Trust
    B.5.2Functional name of contact pointRheumatology Research Fellow
    B.5.3 Address:
    B.5.3.1Street AddressPrittlwell Chase
    B.5.3.2Town/ cityWestcliff-on-Sea
    B.5.3.3Post codeSS0 0RY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01702435555
    B.5.6E-mailmark.williams@southend.nhs.uk
    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 Lodotra
    D.2.1.1.2Name of the Marketing Authorisation holderNapp Pharmaceuticals 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 nameLodotra (delayed release prednisolone)
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrednisolone
    D.3.9.1CAS number 53-03-2
    D.3.9.2Current sponsor codeNP01
    D.3.9.3Other descriptive name17,21-Dihydroxypregna-1,4-diene-3,11,20-trione
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Giant Cell Arteritis
    E.1.1.1Medical condition in easily understood language
    Giant Cell Arteritis (GCA) is a condition in which there is inflammation of the large arteries, predominately those in the head and neck. Symptoms include headache, scalp/jaw pain and vision problems
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10018250
    E.1.2Term Giant cell arteritis
    E.1.2System Organ Class 10047065 - Vascular disorders
    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 purpose of this study is to determine whether delayed release prednisone, in doses equivalent to standard of care immediate release prednisolone, can effectively maintain disease control in new cases of giant cell arteritis.
    E.2.2Secondary objectives of the trial
    Flare free patients in each arm at 26 weeks
    Time to the first flare
    Time to second flare
    Total steroid dosage
    Patient global assessment of disease activity (overall effect of the condition on patient)
    Reduction in levels of inflammation on blood tests (ESR and CRP)
    Improvement in assessment of disability and quality of life (HAQ and Euro QOL 5D)
    Visual Function Questionnaire (VFQ-25) in patients with vision loss (quality of life effect from vision loss)
    Improvement in sleep and fatigue
    Proportion with steroid related side effects in each arm with particular reference to Weight gain, fluid retention, bruising, blood sugar tolerance, raised blood pressure, indigestion
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age ≥50 years
    New diagnosis of GCA within last 4 weeks
    ESR >30 mm/h or CRP >10 mg/dl
    Unequivocal clinical and laboratory picture of GCA either fulfilling American College of Rheumatology criteria or typical features (as assessed by clinician) including one or several of the following:
    - New onset localised pain in the head after 50 years of age
    - Jaw or tongue claudication
    - Visual symptoms (amaurosis fugax, blurring and diplopia)
    - Systemic symptoms not attributable to other causes
    - Limb claudication
    - Polymyalgia
    - Abnormal temporal artery (tender, thickened, beading, decreased pulsation)
    - Scalp tenderness
    - Decreased visual acuity/visual field defect
    - Anterior ischemic optic neuropathy (AION) or central retinal artery occlusion on fundoscopy
    - Upper cranial nerve palsies
    - Typical ischaemic complications of GCA (eg AION)
    E.4Principal exclusion criteria
    GCA on steroid therapy longer than 4 weeks
    Previous exposure to DMARD/biologic therapy
    Serious or chronic infection in the last 3 months.
    Diagnostic doubt
    Failure to respond to high dose steroids within 5 days
    Known other vasculitis
    Patients with evolving ischemic symptoms requiring IV methylprednisolone
    Malignancy
    Patients unable to consent
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients achieving persistent disease control (without features of active disease and remaining flare free at 26 weeks) in each arm.
    E.5.1.1Timepoint(s) of evaluation of this end point
    26 weeks after the patient has been started on steroids
    E.5.2Secondary end point(s)
    Relapse free subjects in each arm at 26 weeks
    Time to the first flare
    Time to second flare
    Cumulative steroid dosage
    Patient global VAS of disease activity
    Reduction of ESR
    Reduction of CRP
    Improvement in HAQ and Euro QOL 5D
    Visual Function Questionnaire (VFQ-25) in patients with vision loss.
    Improvement in sleep and fatigue scores
    Proportion with steroid related toxicity in each arm with particular reference to weight gain, fluid retention, bruising, glucose tolerance, hypertension, dyspepsia
    E.5.2.1Timepoint(s) of evaluation of this end point
    26 weeks after the patient has been started on steroids
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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.8.3 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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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)
    We have arranged for delayed release prednisolone (Lodotra) to be provided free by Napp pharmaceutical company for a further 18 months after the end of the trial to the patients in that arm of the study. This will be 2 years in total which is the usual duration of steroid taper in GCA patients. Those still requiring treatment after that period would likely be on very low doses so could be switched over to regular prednisolone without any detrimental effects.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-25
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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