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    EudraCT Number:2019-004101-27
    Sponsor's Protocol Code Number:INDIGO
    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:2019-12-12
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-004101-27
    A.3Full title of the trial
    INDIGO: Comparing pharmacokinetic parameters of golimumab 50 mg and golimumab 100 mg with a prolonged dose interval in patients with a rheumatic disease, a within-subject controlled study’
    Het beschrijven van farmacokinetische parameters van golimumab in verhoogde dosering en verlengd doseringsinterval: een gecontroleerde studie (de INDIGO-studie)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research into injecting golimumab less frequently by using increased doses
    Onderzoek naar het minder vaak toedienen van een hogere dosering golimumab.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberINDIGO
    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 SponsorSint Maartenskliniek
    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 supportSint Maartenskliniek
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSint Maartenskliniek
    B.5.2Functional name of contact pointJunior Investigator
    B.5.3 Address:
    B.5.3.1Street AddressHengstdal 3
    B.5.3.2Town/ cityUbbergen
    B.5.3.3Post code6574 NA
    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 Simponi
    D. of the Marketing Authorisation holderJanssen Biologics 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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGOLIMUMAB
    D.3.9.1CAS number 476181-74-5
    D.3.9.4EV Substance CodeSUB25638
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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
    rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis
    reumatoïde artritis, artritis psoriatica, axiale spondylartritis
    E.1.1.1Medical condition in easily understood language
    rheumatic disease, chronic inflammation of the joints, Bechterew disease
    reuma, gewrichtsontsteking, Bechterew
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10071400
    E.1.2Term Axial spondyloarthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To describe the peak levels, trough levels and AUC of the following golimumab regimens: 50 mg every month, and 100 mg every one-and-a-half month and 100 mg every two months, in patients with a rheumatic disease.
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of the two 100mg regimens by changes in disease activity (DAS28-CRP, ASDAS, PASDAS) compared to 50mg every month;
    • To identify the proportion of patients with undetectable golimumab levels and / or antibodies to golimumab;
    • To assess the incidence of AEs, with special interest to injection site reactions;
    • To establish which regimen is preferred by patients: 50 mg every month or 100 mg every one-and-a-half month or two months.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Rheumatoid arthritis, psoriatic arthritis or axial spondyloarthritis by fulfilling one of the following:
    o Rheumatoid arthritis: either 2010 ACR RA13 and/or 1987 RA14 criteria and/or clinical diagnosis of the treating rheumatologist;
    o Psoriatic arthritis: Classification Criteria for Psoriatic Arthritis (CASPAR)15 and/or diagnosed with peripheral SpA of the psoriatic arthritis subtype by a rheumatologist;
    o Axial spondyloarthritis: Assessment of SpondyloArthritis international Society (ASAS) classification criteria16 and/or clinical diagnosis of the treating rheuma-tologist;
    • Patients using golimumab in the standard dose of 50mg every month for at least three months with a good clinical response, defined as DAS28-CRP ≤ 2.6 for RA, or PASDAS ≤ 3.2 (PsA) or ASDAS < 2.1;
    • Patient informed consent, ≥16 years old and mentally competent;
    • Ability to measure the outcome of the study in this patient (e.g. patient availability; willing and being able to undergo repeated serum samples);
    • Ability to read and communicate well in Dutch.
    E.4Principal exclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    The main aim of the study is to describe peak levels, trough levels and area-under-the-curve of golimumab 50 mg every month, 100 mg every one-and-a-half month and 100 mg every two months. To measure these parameters, blood samples will be drawn at twelve points during the study. Samples will then be analysed using a validated bioanalytical assay for golimumab in serum at the bioanalytical laboratory of Sanquin.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Twelve points in time over eight months (4 in the 1st month, 2 in the 3rd month, 2 in the 4th month, 1 in the 6th month, 1 in the 7th month en 2 in the eighth month)
    E.5.2Secondary end point(s)
    Disease activity will be measured at maximum one week before or after every second trough level sampling day, to be able to compare the three regimes in efficacy. Disease activity will be measured using the DAS28-CRP for RA, using the PASDAS for PsA and using the ASDAS for axSpA. Therefore, the following outcomes will be collected:
    - Acute phase reactants: CRP (for RA, PsA and axSpA) and ESR (axSpA);
    - Physician Global Assessment of disease activity (PsA);
    - Patient Global Assessment of disease activity (RA, PsA, axSpA);
    - BASDAI/ASDAS-questionnaire (axSpA);
    - SF-12 questionnaire (PsA);
    - Physical examination: tender joint count (RA, PsA), swollen joint count (RA, PsA), dactylitis and enthesitis (using the Leeds Enthesitis Index (PsA)).
    The acute phase reactants analysis will be performed in the laboratory of the Canisius Wilhelmina Hospital, located in the Sint Maartenskliniek.

    Presence of anti-drug antibodies against golimumab will be measured in the proportion of patients with undetectable golimumab levels. This means that in patients with golimumab levels < 0.1 mg/L17 anti-drug antibodies will be measured in serum. Samples will then be analysed using a validated ADA radio-immune assay at the bioanalytical laboratory of Sanquin.

    Adverse events
    The occurrence of adverse events during the study period will be registered using the Common Toxicity Criteria for Adverse Events (CTCAE). [BRON] For injection site reactions, a list with symptoms associated to injection site reactions will be used, for example local redness and itches.

    Regime preference
    At the last study visit, patients will be asked which medication regimen they preferred.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Adverse events and efficacy at the 4th, 8th and 12th visit
    Regime preference at the 12th visit
    Antibody development can be checked for every blood sample of golimumab, when concentration is < 0.1 mg/L
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    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. description
    Golimumab 100 mg every 1,5 and 2 months respectively, will be compared to 50 mg every month
    E.8.2.4Number of treatment arms in the trial1
    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 years1
    E.8.9.1In the Member State concerned months6
    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: 35
    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 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 state35
    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)
    Patients have the option to continue treatment using the standard or one of the investigational regimes, in shared decision with their treating rheumatologist.
    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 Decision2019-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-15
    P. End of Trial
    P.End of Trial StatusOngoing
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