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    Summary
    EudraCT Number:2018-002362-39
    Sponsor's Protocol Code Number:COMPLETE-PsA
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-07-09
    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 number2018-002362-39
    A.3Full title of the trial
    Comparing Methotrexate monotherapy with methotrexate Plus LEflunomide combination ThErapy in Psoriatic Arthritis: A pragmatic randomized placebo-controlled double-blind clinical trial.


    Vergelijken van methotrexaat monotherapie met methotrexaat en leflunomide combinatie therapie in artritis psoriatica: een pragmatische gerandomiseerde, placebo-gecontroleerde, dubbelblinde klinische trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Methotrexate and leflunomide combination therapy in psoriatic arthritis.
    Methotrexaat en leflunomide combinatietherapie bij artritis psoriatica.
    A.3.2Name or abbreviated title of the trial where available
    Comparing methotrexate with methotrexate plus leflunomide in psoriatic arthritis
    A.4.1Sponsor's protocol code numberCOMPLETE-PsA
    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 SponsorSt Maartenskliniek
    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 supportSt Maartenskliniek
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSt Maartenskliniek
    B.5.2Functional name of contact pointMark Wenink
    B.5.3 Address:
    B.5.3.1Street AddressHenstdal 3
    B.5.3.2Town/ cityUbbergen
    B.5.3.3Post code6574 NA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031243659275
    B.5.6E-mailm.wenink@maartenskliniek.nl
    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.2.1.1.1Trade name Leflunomide (Arava)
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameLeflunomide
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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 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.2.1.1.1Trade name Methotrexate (pharmachemie)
    D.2.1.1.2Name of the Marketing Authorisation holderpharmachemie
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameMethotrexate
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    Subcutaneous 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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adults diagnosed with Psoriatic Arthritis
    E.1.1.1Medical condition in easily understood language
    Psoriatic arthritis
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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 compare the effectiveness of MTX monotherapy with MTX and LEF combination therapy in cDMARD-naïve psoriatic arthritis patients.
    E.2.2Secondary objectives of the trial
    Key secondary parameters are: change in skin score, enthesitis score, dactylitis score and swollen/tender joint count. Furthermore, the difference in immunoprofile, treatment failure, and the percentage of (S)AE’s between the two groups will be assessed.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Adult male or female
    -Age ≥18 years
    -Clinical diagnoses of PsA
    -Evidence of active disease defined as ≥2 swollen joints, dactylitis counts as 1 swollen joint.
    -Subjects that have used cDMARDs and/or bDMARDs before, must have discontinued this treatment for at least 6 months prior to baseline visit.
    -Subjects who are already taking NSAIDs/COX-2 inhibitors may participate in the study but the dose has to be stable for at least one week prior to first dose of study drug
    -Oral or injected corticosteroids (intramuscular, intravenous and intra-articular) have to be discontinued 8 weeks prior to first dose of study drug
    E.4Principal exclusion criteria
    -Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for approximately 2 years after the last dose of study drug or up to 11 days after treatment when washout procedure is executed.
    -Male subject who is considering fathering a child or donating sperm during the study or for approximately 2 years after the last dose of study drug or up to 11 days after treatment when washout procedure is executed.
    -History of an inadequate response to MTX or LEF (prescribed by a rheumatologist for joint disease).
    -Current severe infection including, but not limited to:
    oActive human immunodeficiency virus (HIV)
    oActive TB
    -History of an allergic reaction or significant sensitivity to constituents of the study drugs (MTX/LEF)
    -Current or history of liver insufficiency
    -History of clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months prior to baseline visit.
    -Current or recent history of a severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular or neurologic disease.
    -History of any fibromyalgia or diagnosis of inflammatory rheumatic disease other than PsA. Prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly.
    -Abnormal laboratory values within 1 month prior to baseline visit:
    oSerum alanine transaminase (ALT) > 1.5 × ULN;
    oEstimated glomerular filtration rate (GFR) by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula < 40 mL/min/1.73m2;
    oTotal white blood cell count (WBC) < 3,000/μL;
    oPlatelet count < 100,000/μL;
    oHemoglobin < 10 g/dL (6.3 mmol/L).
    -Current persistent hypertension requiring start or change of treatment regimen
    -Malignancy in the past 5 years except for non-melanoma skin cancer
    E.5 End points
    E.5.1Primary end point(s)
    PASDAS score at 16 weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline
    week 16
    E.5.2Secondary end point(s)
    Clinical:
    -The difference in proportion of patients in LDA state, PASDAS ≤3.2, in PsA patients between the two arms at week 16
    -The difference in proportion of patients in LDA state (DAPSA ≤14) in PsA patients between the two arms at week 16
    -The change of DAPSA score from baseline to 16 weeks
    -The difference in proportion of patients fulfilling Minimal Disease Activity (MDA) criteria between the two arms at week 16
    -The disease impact and quality of life of patients with PsA from pre- to post treatment:
    •PsA impact of disease (PSAID) at baseline and week 16
    •Health assessment questionnaire (HAQ) at baseline and week 16
    •Short Form (12) Health Survey (SF12) at baseline and week 16
    -The change in skin score (PGA, BSA) between baseline and 16 weeks
    -The change in swollen joint count between baseline and 16 weeks
    -The change in tender joint count between baseline and 16 weeks
    -The change in dactylitis score between baseline and 16 weeks
    -The change in enthesitis score between baseline and 16 weeks

    Laboratory:
    -To assess whether baseline ‘ immunoprofiling’ factors of patients are predictive for treatment response on MTX monotherapy or MTX and LEF combination therapy

    Safety:
    -The safety of MTX and LEF combination therapy, by comparing the percentage of adverse events and serious adverse events between the 2 arms
    E.5.2.1Timepoint(s) of evaluation of this end point
    baseline
    week 16
    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 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) 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 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 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 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 years3
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 Information not present in EudraCT
    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 state78
    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)
    No specific plans (according to local protocol).
    If treatment is succesful, patients will continue therapy. If treatment is not succesful, further treatment desicions are according to local protocol.
    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 Decision2018-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-06-30
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