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    Summary
    EudraCT Number:2015-004334-99
    Sponsor's Protocol Code Number:151201
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-11-30
    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 ConcernedSweden - MPA
    A.2EudraCT number2015-004334-99
    A.3Full title of the trial
    Treatment of Graves´ ophthalmopathy with diclofenak or simvastatin
    Behandling av Graves oftalmopati med diklofenak eller simvastatin
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of Graves´ ophthalmopathy with diclofenak or simvastatin
    Behandling av Graves oftalmopati med diklofenak eller simvastatin
    A.3.2Name or abbreviated title of the trial where available
    GO-DS
    GO-DS
    A.4.1Sponsor's protocol code number151201
    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 SponsorDepartment of Endocrinology
    B.1.3.4CountrySweden
    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 supportDepartment of Endocrinology
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Endocrinology
    B.5.2Functional name of contact pointMikael Lantz
    B.5.3 Address:
    B.5.3.1Street AddressJan Waldenströmsgata 15
    B.5.3.2Town/ cityMalmö
    B.5.3.3Post code20502
    B.5.3.4CountrySweden
    B.5.4Telephone number046403310002286
    B.5.6E-mailMikael.Lantz@med.lu.se
    D. IMP Identification
    D.IMP: 1
    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 Diclofenac T Ratiopharm
    D.2.1.1.2Name of the Marketing Authorisation holderTeva
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameDiclofenac T Ratiopharm
    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 INNDiclofenac
    D.3.9.3Other descriptive nameDICLOFENAC
    D.3.9.4EV Substance CodeSUB07092MIG
    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) 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 Simvastatin Teva
    D.2.1.1.2Name of the Marketing Authorisation holderTeva
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameSimvastatin Teva
    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 INNsimvastatin
    D.3.9.3Other descriptive nameSIMVASTATIN
    D.3.9.4EV Substance CodeSUB10529MIG
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Graves´ophthalmopathy
    Graves oftalmopati
    E.1.1.1Medical condition in easily understood language
    Graves´ophthalmopathy
    Graves oftalmopati
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine Clinical activity score (CAS) after 6 months treatment with or without diclofenak or simvastatin and progression to severe GO
    Att utvärdera Clinical activity score (CAS) efter 6 månaders behandling med diklofenak eller simvastatin
    E.2.2Secondary objectives of the trial
    1. To evaluate whether modified CAS is better than CAS in discriminating changes in activity score?
    2. To evaluate conjunctival thickness with optical coherence tomography after 3 and 6 months treatment with diclofenak or simvastatin
    3. To evaluate quality of life after 6 months treatment with diclofenak or simvastatin
    4. To evaluation changes in TRAb and TPOAb after 3 and 6 months treatment with diclofenak or simvastatin?
    5. To evaluation novel markers of active ophthalmopathy identified with microarray, metabolomics and bioassays after 3 and 6 months treatment with diclofenak or simvastatin?
    1. Att utvärdera om modifierad CAS ökad chans till att påvisa förändringar i aktiviteten jämfört med CAS?
    2. Att utvärdera om TRAK och anti-TPO påverkas av 6 månaders behandling med diklofenak eller simvastatin
    3. Att utvärdera om nya markörer för aktiv oftalmopati kan identifieras med ”microarray”, ”metabolomics” och ”bioassays” och påverkas dessa av behandling med diklofenak eller simvastatin?
    4. Att utvärdera om konjunktival tjocklek, bestämd med optical coherence tomography (OCT), påverkas av diklofenak eller simvastatin?
    5. Att utvärdera om livskvaliten påverkas av behandling med diklofenak eller simvastatin?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18-70 years
    2. Active mild to moderate with at least one sign of mild GO (NO SPECS class 2a and b) with reference to Colour Atlas at EUGOGO website (www.eugogo.eu). Exophthalmos up to 24 mm with a disease duration of <18 months (as recorded by the patient)
    3. a. Graves´ disease with clinical and laboratory euthyroidism after stopping treatment with anti thyroid drugs (ATD)
    b. or 2 months treatment with ATD
    c. or euthyroid 6 months after treatment with radioiodine
    d. or euthyroid after total thyroidectomy.
    Clinical and laboratory euthyroidism is defined as normal fT4, fT3 and TSH below the upper limit of the local reference interval (Malmö 3.7, Odense? Århus 4.3) and no clinical symtoms or signs of hyperthyroidism. L-thyroxine is used to achieve euthyroidism during the study period.
    1. Ålder 18-70 år
    2. Aktiv mild till måttlig GO med åtminstone ett tecken på mild GO (NO SPECS klass 2a och b) enligt färg atlas på EUGOGOs web sida (www.eugogo.eu). Exoftalmos upp till 24 mm med en sjukdomsduration på < 18 månader (enligt patienten)
    3. a. Graves sjukdom med klinisk och laboratoriemässig eutyreoidism efter avslutad behandling med tyreostatika
    b. eller 2 månaders behandling med tyreostatika
    c. eller eutyreoidism 6 månader efter behandling med radiojod
    d. eller eutyreoidism efter total tyreoidektomi.
    Klinisk och laboratoriemässig eutyreoidism definieras som normalt fT4, fT3 och TSH under den övre referensgränsen för det lokala laboratoriets referensintervall (Malmö, Odense, Århus) och avsaknad av kliniska symtom och tecken på hypertyreoidism. L-thyroxine används för substitution under studieperioden.
    E.4Principal exclusion criteria
    1. Pregnancy or breast-feeding
    2. Previous treatment for GO
    3. Severe GO requiering corticosteroid treatment, retrobulbar irradiation, orbital or decompression surgery
    4. Current or previous treatment with diclofenak (within 3 months for more than 7 consecutive days) or simvastatin or other statins (within 3 months)
    5. Allergy (skin rash or systemic reactions) to NSAID, ASA or statins
    6. Congestive heart failure
    7. Renal insufficiency (glomerular filtration rate <60 ml/min)
    8. ASAT or ALAT > 2.5 times the upper limit of the local laboratory
    9. Alcoholism as judged by local criteria
    10. Coagulopathy including treatment with warfarin or new oral anti-coagulation drugs
    11. Previous or current gastric ulcer
    12. Inflammatory bowel disease diabetic retinopathy or nephropathy
    13. Trauma within 10 Days
    Graviditet och amning
    Tidigare behandling av Graves oftalmopati
    Steroidkrävande oftalmopati
    Pågående behandling med diklofenak eller simvastatin
    Överkänslighet mot NSAID, ASA eller simvastatin
    Hjärtsvikt
    Njurinsufficiens (GFR <60)
    Levercirrhos
    Alkoholism
    Känd koagulationsrubbning (inkl beh med Waran eller NOAK)
    Tidigare eller aktivt ulcus
    Ulcerös kolit
    Diabetesretinopati /nefropati
    Trauma < 10 dagar
    E.5 End points
    E.5.1Primary end point(s)
    1. Clinical activity score (CAS) after 6 months treatment with or without diclofenak or simvastatin and progression to severe GO
    1. Clinical activity score (CAS) utvärderas efter 6 månaders behandling med diklofenak eller simvastation samt progress till svår oftalmopati
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 månader
    E.5.2Secondary end point(s)
    1. Evaluation of whether modified CAS is better than CAS in discriminating changes in activity score?
    2. Evaluation of conjunctival thickness with optical coherence tomography after 3 and 6 months treatment with diclofenak or simvastatin
    3. Evaluation of quality of life after 6 months treatment with diclofenak or simvastatin
    4. Evaluation of changes in TRAb and TPOAb after 3 and 6 months treatment with diclofenak or simvastatin?
    5. Evaluation of novel markers of active ophthalmopathy identified with microarray, metabolomics and bioassays after 3 and 6 months treatment with diclofenak or simvastatin?
    1. Ger modifierad CAS ökad chans till att påvisa förändringar i aktiviteten jämfört med CAS?
    2. Påverkas TRAK och anti-TPO av 6 månaders behandling med diklofenak eller simvastatin
    3. Kan nya markörer för aktiv oftalmopati identifieras med ”microarray”, ”metabolomics” och ”bioassays” och påverkas dessa av behandling med diklofenak eller simvastatin?
    4. Påverkas konjunktival tjocklek, bestämd med optical coherence tomography (OCT), av diklofenak eller simvastatin?
    5. Påverkas livskvaliten av behandling med diklofenak eller simvastatin?
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months
    6 months
    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 No
    E.6.5Efficacy No
    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 No
    E.8.1.3Single blind Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Ingen behandling
    No treatment
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 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
    Last visit of last subject
    Sista besök av sista patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 92
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state34
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 68
    F.4.2.2In the whole clinical trial 102
    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)
    None
    Ingen
    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 Decision2016-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-15
    P. End of Trial
    P.End of Trial StatusOngoing
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