Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    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.
    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) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-002511-34
    Sponsor's Protocol Code Number:V1.0.14062017
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-04-17
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-002511-34
    A.3Full title of the trial
    Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in CIDP
    (OPTIC trial)
    Intraveneus immunoglobuline en intraveneus methylprednisolon als optimale inductie behandeling in CIDP
    (OPTIC trial)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in CIDP
    (OPTIC trial)
    Intraveneus immunoglobuline en intraveneus methylprednisolon als optimale inductie behandeling in CIDP
    (OPTIC trial)
    A.3.2Name or abbreviated title of the trial where available
    OPTIC trial
    OPTIC trial
    A.4.1Sponsor's protocol code numberV1.0.14062017
    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 SponsorAcademisch Medisch Centrum
    B.1.3.4CountryNetherlands
    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 supportPrinces Beatrix Spierfonds
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportZonMW
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportSanquin
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademisch Medisch Centrum
    B.5.2Functional name of contact pointFilip Eftimov
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+310205668728
    B.5.6E-mailf.eftimov@amc.uva.nl
    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 Methylprednisolone (Solu-Medrol)
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer b.v.
    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.3.1Product nameMethylprednisolon (Solu-Medrol)
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 Sodium Chloride 0.9%
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter B.V.
    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.3.1Product nameSodium Chloride 0.9%
    D.3.2Product code RVG 56083
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic inflammatory demyelinating polyneuropathy (CIDP)
    Chronische inflammatoïre demyeliniserende polyneuropathie (CIDP)
    E.1.1.1Medical condition in easily understood language
    Chronic inflammatory demyelinating neuropathy (CIDP) is a disorder of the peripheral nerves which leads to loss of muscle strength and / or sensory loss in the arms and legs
    Chronische inflammatoïre demyeliniserende polyneuropathie (CIDP) is een zenuwontsteking van de perifere zenuwen resulterend in krachtverlies en/of gevoelsstoornissen aan armen en benen.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective of this randomized controlled trial is to assess whether combining IVIg and IVMP leads to more frequent long-term remission in CIDP compared to treatment with IVIg alone.
    Het doel van dit onderzoek is om te bestuderen of het toevoegen van methylprednisolon aan de standaard behandeling met intraveneuze immunoglobulines (IVIg) tot een betere uitkomst leidt dan het gebruik van IVIg alleen.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to explore whether this leads to a higher and faster rate of improvement and whether this combination reduces CIDP associated health care costs en increases quality of life.
    Secundaire doelstelling is om te bepalen of er sneller en betere klinische verbetering optreedt en of deze behandelcombinatie CIPD gerelateerde zorgkosten verlaagd en kwaliteit van leven verbeterd.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion of patients is based on the presence of active disease and fulfillment of the probable or definite
    EFNS/PNS criteria for CIDP. All new and untreated adult patients are eligible for the study. In addition we will include CIDP patients, treated previously, who have a disease relapse after a remission of at least 1 year, and patients who have responded to their first course of IVIg in the last three months but deteriorated afterwards.
    Patiënten worden geincludeerd als wordt voldaan aan de EFNS/PNS criteria van zeker ('definite') of waarschijnlijk (' probable') CIPD. Alle nieuwe en onbehandelde patiënten komen in aanmerking voor de studie. Ook reeds behandelde CIPD patiënten komen in aanmerking, indien zij een tenminste een jaar in remissie zijn geweest. Ook patiënten die in de laatste 3 maanden klinisch zijn verbeterd na hun eerste IVIg kuur, maar daarna verslechterden, komen in aanmerking.
    E.4Principal exclusion criteria
    1) Presence of IgM paraproteinemia , anti-MAG antibodies or CIDP specific antibodies associated with poor treatment response to IVIg
    2) Use of drugs associated with a demyelinating neuropathy
    3) Use of any immunosuppressive or immunomodulatory drugs in previous 6 months (except for a single loading dose of IVIg within 3 months), with the exception of low dose prednisone (20 mg or less for the duration of two weeks).
    4) Known serious adverse events with previous IVIg or corticosteroid treatment
    5) One of more of the risk factors associated with increased risk of adverse events of IVIg or IVMP or conditions that could lead to unblinding of treatment (i.e. diabetes; IgA deficiency; gastric ulcers; psychosis; severe hypertension (180/110 mmHg or more on repeated measurements); hypocalcaemia (lower than 2.20 mmol/L, corrected for albumin); moderate or severe heart failure; severe cardiovascular disease (i.e. more than one myocardial infarction and or ischemic stroke); renal failure (glomerulal filtratrion rate < 30 ml/min)
    6) History of osteoporosis or osteoporotic fractures
    7) Known malignancy with survival expectancy of less than 1 year
    8) Bodyweight more than 120 kg
    9) Pregnancy or nursing mother; intention to become pregnant during the course of the study; female patients of childbearing potential either not using or not willing to use a medically reliable method of contraception for the entire duration of the study
    10) Cataract
    11) Psychosis
    12) Poor dental status
    13) Legally incompetent adults
    14) Lack of written informed consent
    1) aanwezigheid van IgM paraproteinemie, anti-MAG antilichamen en CIDP specifieke antilichamen (geassocieerd met een slechte response op behandeling met IVIg)
    2) Gebruik van geneesmiddelen die geassocieerd zijn met (het ontstaan van) demyeliniserende polyneuropathieen
    3) Gebruik van immunosuppresieve geneesmiddelen in de afgelopen 6 maanden, met uitzondering van een (enkele) oplaaddosis IVIg in de laatste 3 maanden en een lage dosis prednison (< 20 mg) gedurende 2 weken.
    4) Bekende allergische reactie of ernstige bijwerkingen na eerdere behandeling met IVIg of corticosteroiden
    5) Een of meerdere risicofactoren geassocieerd met een verhoogde kans op 'adverse events' vanwege IVIg en/of IVMP gebruik, of factoren die op zichzelf kunnen leiden tot deblindering: diabetes mellitus, IgA deficientie, ulcus pepticum, psychose, ernstige hypertensie (180/110 mmHg of hoger, op herhaalde metingen), hypocalciemie (lager dan 2.20, gecorrigeerd voor serum albumine), matig tot ernstig hartfalen, ernstig cardiovasculair lijden ( 1 of meer hartinfarcten of herseninfarcten), nierfalen (eGFR < 30 ml).
    6) Voorgeschiedenis bekend met osteoporose of osteoporotische fracturen
    7) Bekende maligniteit met een levensverwachting van < 1 jaar
    8) Gewicht > 120 kg
    9) Zwangerschap of het geven van borstvoeding; actieve zwangerschapswens tijdens duur studie; vrouwen die geen betrouwbare anticonceptie gebruiken of willen gebruiken gedurende de studie periode.
    10) Staar/ cataract
    11) Psychose
    12) Slechte staat van het gebit
    13) Wilsonbekwame volwassenen
    14) Ontbreken van (ondertekende) informed consent
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome is the number of patients in remission at 1 year after start of an 18 weeks treatment period. Remission is defined as sustained improvement without the need for further treatment. Improvement is defined as improvement by at least the minimal clinical important difference (MCID) on the I-RODS and/or improvement of one or more points on the INCAT disability scale at 18 weeks compared to baseline. Sustained is defined as no deterioration between 18 weeks and 52 weeks, i.e. difference on the I-RODS of less than the individual MCID difference and one or more points on the INCAT disability scale. Patients will be considered as a treatment failure if they 1) receive additional CIDP treatment during the 18-week intervention period, 2) do not improve at 18 weeks, 3) restart CIDP treatment for any reason between 18 and 52 weeks, or 4) do not show a sustained improvement at 52 weeks as defined above.
    Aantal patiënten in remissie, 1 jaar na start van de behandeling. Remissie is gedefineerd als een stabiel ziektebeloop zonder noodzaak tot verdere behandeling. Klinisch verbetering is gedefinieerd als verbetering van invaliditeit (MCID) op de iRODS vragenlijst en/of verbetering van 1 of meer punten op de INCAT disability scale. Patiënten worden gerekend tot 'treatment failure' als 1) er opnieuw behandeld moet worden in de eerste 18 weken, 2) er geen verbetering heeft opgetreden in de eerste 18 weken, 3) er opnieuw behandeling moet worden gestart tussen 18 en 52 weken, 4) als er geen sprake is van een remissie na 52 weken.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoint will be evaluated at 52 weeks.
    Primaire uitkomst wordt op 52 bepaald.
    E.5.2Secondary end point(s)
    1) The number of patients with improvement on disability equal or more than the MCID;
    2) Time to improvement (≥ MCID) on disability;
    3) Mean change in disability;
    4) Mean change in grip strength;
    5) Mean change in muscle strength;
    6) Mean change in sensory impairment (INCAT SS);
    7) Mean change in fatigue;
    8) Mean change in pain;
    9) Mean change in health related quality of life (HRQL);
    10) Number of (serious) adverse events (including corticosteroid associated adverse events);
    11) Care use and overall healthcare-related costs;

    1) Het aantal patiënten met verbetering van hun invaliditeit (meer dan de MCID);
    2) Tijd tot verbetering (≥ MCID) invaliditeit;
    3) Gemiddelde verandering in invaliditeit;
    4) Gemiddelde verandering knijpkracht;
    5) Gemiddelde verandering spierkracht;
    6) Gemiddelde verandering sensibele beperkingen (INCAT SS);
    7) Gemiddelde verandering met betrekking tot vermoeidheid;
    8) Gemiddelde verandering met betrekking tot pijnklachten;
    9) Gemiddelde verandering kwaliteit van leven (HRQL);
    10) Aantal bijwerkingen: (serious) adverse events, (S)AEs;
    11) Zorggebruik en algemene zorg gerelateerde kosten;
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 18 and 52 weeks. Measuring of these parameters is done consistently (table 1 and 2 in the study protocol, version 4.4.) in the intervention and follow up period. Main secondary outcomes are evaluated at 18 and 52 weeks. Secondary outcomes are also determined according to follow-up protocol (the schedule of which is refered to previously) in case an early endpoint is reached.
    op 18 en 52 weken. Deze parameters worden frequent gemeten (tabel 1 en 2 van het protocol, versie 4.4.). Secundaire uitkomstmaten worden primair geëvalueerd op 18 en 52 weken. Het follow-up protocol en het meten van secundaire uitkomstmaten verloopt volgens het eerder genoemde schema, ook als een vroege eindpunt wordt gehaald.
    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 Yes
    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) Yes
    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) 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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 day of follow up for last included patient
    Na het einde van de follow up voor de laatst geincludeerde patient
    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 months0
    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 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 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: 96
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 20
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 96
    F.4.2.2In the whole clinical trial 96
    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)
    Treatment according to existing treatment protocols
    Volgens de huidige landelijke of instellingsprotocollen
    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 Decision2018-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-15
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA