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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   42869   clinical trials with a EudraCT protocol, of which   7063   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) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2013-005376-17
    Sponsor's Protocol Code Number:201401
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-02-27
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-005376-17
    A.3Full title of the trial
    Sandostatin therapy in sarcoidosis
    Sandostatine therapie bij sarcoïdose
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sandostatin therapy in sarcoidosis
    Sandostatine therapie bij patiënten met sarcoïdose
    A.3.2Name or abbreviated title of the trial where available
    SST in SA
    SST bij SA
    A.4.1Sponsor's protocol code number201401
    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 SponsorErasmus Medical Center
    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 supportNovartis Pharma
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus Medical Center
    B.5.2Functional name of contact pointCoordinating investigator
    B.5.3 Address:
    B.5.3.1Street Address's Gravendijkwal 230
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 CE
    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. name Sandostatin LAR
    D. of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOCTREOTIDE
    D.3.9.1CAS number 83150-76-9
    D.3.9.2Current sponsor codeSMS 201-995
    D.3.9.3Other descriptive nameoctreotide LAR / Sandostatin LAR (LAR=long acting release)
    D.3.9.4EV Substance CodeSUB09417MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 30
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    E.1.1.1Medical condition in easily understood language
    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 16.1
    E.1.2Level HLGT
    E.1.2Classification code 10003816
    E.1.2Term Autoimmune disorders
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate efficacy of SST looking at the change in uptake on SRS in a subset of chronically active patients in which intensification of corticosteroid therapy is not indicated.
    Het evalueren van de effectiviteit van sandostatine door een verschil in uptake in SRS in een subset van sarcoïdose patienten bij wie geen noodzaak is tot intensivering van therapie met corticosteroïden.
    E.2.2Secondary objectives of the trial
    To study the composite clinical score using the following parameters: blood test (ESR, CRP, full blood count, lysozyme, ACE, 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, sIL-2R), quality of life (RAND-36) and when applicable lung function test (FVC, DLCO) and skin evaluation.
    Bestuderen van een samengestelde klinische score gebaseerd op de volgende parameters: bloedtest ( BSE, CRP, bloedbeeld, lysozym, ACE, 25-hydroxyvitamine D, 1.25-dihydroxyvitamine D, sIL-2R), kwaliteit van leven (RAND-36) en waar mogelijk longfunctie test (FVC, DLCO) en huidbeoordeling.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age above 18 years with obtained written consent
    • Have biopsy-proven symptomatic, stable, chronic sarcoidosis for minimal three years.
    • Have a positive SRS
    • Involvement of skin, joint, lymph nodes or lung. Patients with pulmonary involvement have a diffusing capacity between 60 and 75 percent.
    Leeftijd boven 18 jaar
    Histologisch bewezen, symptomatische, stabiele, chronische sarcoidose minstens 3 jaar.
    Postieve Somatostatine receptor scan
    Betrokkenheid van huid, gewricht, lymfeklieren, long ( diffusiecapaciteit tussen 60-75 %)
    E.4Principal exclusion criteria
    • Corticosteroid use up to three months prior of trial
    • Chronic renal failure defined as a GFR below 50%
    • Liver disease
    • Have an indication for intensifying immunosuppressive therapy; threatening organ damage
    • Have received anti TNF-α therapy
    • Have an underlying cardiac disease
    Corticosteroid gebruik korter dan drie maanden voor trial
    Chronisch nierfalen met een GFR onder 50%
    Indicatie voor intensifering van therapie door dreigende orgaanschade
    Eerdere behandeling met TNF blokkers
    Onderliggende cardiale ziekte
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate efficacy of SST in a subset of patients that are refractory/intolerant for corticosteroid therapy by a change in uptake on SRS. Change in uptake in SRS, defined as improved, no change, worse.
    Verschill in uptake op de somatostatine receptor scan gedefinieerd als verbeterd, onveranderd en verslechterd
    E.5.1.1Timepoint(s) of evaluation of this end point
    Before start of study and at month 9.
    Voor de eerste gift van sandostatine en na 9 maanden.
    E.5.2Secondary end point(s)
    To study the composite clinical score using the following parameters. Measurements of ESR, CRP, full blood count, lysozyme, ACE, 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D3 sIL-2R. Quality of life score assessment with RAND-36 will be conducted. When applicable lung-function test with FVC and DLCO and skin evaluation will take place.
    Bloedtesten: BSE, CRP, Bloedbeeld, lysozym, ACE, 25-hydroxyvitamine D, 1.25-dihydroxyvitamine D, sIl-2R. Kwaliteit van leven beoordeling met de RAND-36. Wanneer mogelijk longfunctie test met FVC en DLCO en huidbeoordeling.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Bloodtests, quality of life and skin assesment takes place before start of study and at 2 weeks and 3, 6, 9, 12 months. Lungfunction before trial and at 6 months.
    Bloedtesten, kwaliteit van leven vragenlijst en huidbeoordeling vinden plaats voor de eerste gift en bij 2 weken, 3, 6, 9 en 12 maanden. Longfunctie test voor de eerste gift en na 6 maanden.
    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 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. 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 No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 20
    F.1.3Elderly (>=65 years) No
    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 state20
    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)
    All patients stop with sandostatine treatment after six injections. When a good therapeutic respons was seen, but decreased when treatment was stopped, patients will restart sandostatine.
    Alle patienten krijgen zes injecties sandostatine, daarna wordt gestopt. Mocht er een goede therapeutische respons zijn die afneemt na het stoppen dan kan sandostatine hervat worden.
    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 Decision2014-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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