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    Summary
    EudraCT Number:2017-002511-34
    Sponsor's Protocol Code Number:v3.0.15JAN2019
    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:2019-11-08
    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 number2017-002511-34
    A.3Full title of the trial
    Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in CIDP
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Initial treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) - combined immunoglobulin and steroid treatment versus immunoglobulin treatment alone.
    A.3.2Name or abbreviated title of the trial where available
    OPTIC Trial
    A.4.1Sponsor's protocol code numberv3.0.15JAN2019
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN15893334
    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 SponsorAcademic Medical Centre, Amsterdam, NL
    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.4.1Name of organisation providing supportGBS/CIDP Foundation International
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMRC Centre for Neuromuscular Diseases, National Hospital for Neurology and Neurosurgery, UCLH
    B.5.2Functional name of contact pointLaura Zambreanu
    B.5.3 Address:
    B.5.3.1Street Address8-11 Queen Square
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC1N 3BG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number07799626653
    B.5.5Fax number02034488036
    B.5.6E-maill.zambreanu@nhs.net
    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
    D.2.1.1.2Name of the Marketing Authorisation holderBeacon Pharmaceuticals Limited, DCC Vital Westminster Industrial Estate, Repton Road, Measham, DE12
    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 namemethylprednisolone
    D.3.4Pharmaceutical form Powder and solvent for solution for injection/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 Healthcare Ltd, Caxton Way, Thetford, Norfolk IP24 3SE, United Kingdom
    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 namesodium chloride 0.9%
    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)
    E.1.1.1Medical condition in easily understood language
    Longstanding inflammatory disease of the nerves leading to significant weakness, numbness and fatigue.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057645
    E.1.2Term Chronic inflammatory demyelinating polyradiculoneuropathy
    E.1.2System Organ Class 10029205 - Nervous 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
    Does initial treatment with both intravenous immunoglobulin and intravenous methylprednisolone lead to more frequent long-term remission (defined as sustained improvement without need for further treatment) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) compared to initial treatment with intravenous immunoglobulin alone?
    E.2.2Secondary objectives of the trial
    Compared to intravenous immunoglobulin alone, does initial combination treatment with intravenous immunoglobulin and intravenous methylprednisolone in chronic inflammatory demyelinating polyneuropathy (CIDP) patients lead to:
    1. higher rates of improvement?
    2. faster speed of improvement?
    3. less healthcare costs?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Probable or definite CIDP according to the EFNS/PNS criteria 2010 (all CIDP phenotypes).
    2) Age ≥ 18 years.
    3a) Treatment naïve patients (no previous immune treatment for CIDP); or
    3b) Previously immune-treated patients who have a relapse after a remission of at least 1 year; or
    3c) Patients treated with subjective or objective improvement after a single loading course of IVIg in the last 3 months, and subsequent deterioration as judged by their treating physician.
    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 or low dose prednisolone (20 mg or less) during a short period (maximum 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 (glomerular filtration rate < 30 ml/min).
    6) History of osteoporosis or osteoporotic fractures.
    7) Known active malignancy, currently treated with chemotherapy or immunomodulatory drugs, or with a life 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 (from menarche until 1 year after the last period, surgical menopause or sterilization procedure) either not using or not willing to use a medically reliable method of contraception for the entire duration of the study.
    10) Known cataract or cataract obvious on fundoscopy.
    11) Current psychosis or past history of psychosis.
    12) Poor dental status.
    13) Known pulmonary embolism or other deep venous thrombosis in patient’s medical history, without current anticoagulant therapy.
    14) Patient lacking capacity to consent to enter the trial.
    15) Lack of written informed consent
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure 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 receiving any further immune treatment (as defined below under treatment failure).

    Improvement is defined as improvement by at least the minimal clinical important difference (MCID) on the inflammatory Rasch-Overall Disability Scale (I-RODS), and/or improvement of one or more points on the Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale, at 18 weeks compared to baseline.

    Sustained is defined as no deterioration between 18 weeks and 52 weeks, where deterioration is defined as worsening on the I-RODS by at least the MCID and/or on the INCAT disability scale by one or more points.

    A patient will be considered as a treatment failure and therefore not in remission if they 1) receive additional immune treatment for CIDP (other than that in the protocol) during the 18-week intervention period, 2) have not improved at 18 weeks, 3) receive any immune treatment for CIDP for any reason between 18 and 52 weeks, or 4) do not show a sustained improvement at 52 weeks as defined above.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year after the start of an 18 week treatment period.
    E.5.2Secondary end point(s)
    1) The number of patients with improvement on disability equal or more than the minimal clinically important difference (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 by MRC sum score;
    6) Mean change in sensory impairment;
    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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will be assessed at 18 and 52 weeks, or earlier if a preliminary endpoint (treatment failure) is reached (i.e. additional treatment is started during the 18 week treatment period or between 18 and 52 weeks).
    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 Yes
    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 concerned6
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days30
    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: 45
    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 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 state45
    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)
    At the end of the research, patients will receive standard NHS care for their CIDP. Both IVIg and IVMP are licensed medications for this condition, and therefore both could be continued if clinically indicated.
    Patients who respond to our treatment by entering clinical remission, will not need any ongoing treatment, but will continue to be followed up regularly in case of a relapse.
    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 Decision2019-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-01
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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