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    Summary
    EudraCT Number:2013-000643-40
    Sponsor's Protocol Code Number:50307
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-09-24
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2013-000643-40
    A.3Full title of the trial
    A multicentre, randomized, double-blind, parallel–group study to compare the efficacy of golimumab in combination with methotrexate (MTX) versus MTX monotherapy, in improving dactylitis and enthesitis, in MTX naïve psoriatic arthritis patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Golimumab efficacy in psoriatic arthritis patients with active dactylitis
    A.3.2Name or abbreviated title of the trial where available
    GO-DACT
    A.4.1Sponsor's protocol code number50307
    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 SponsorInstituto de Medicina Molecular
    B.1.3.4CountryPortugal
    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 supportMerck Sharp & Dohme, LDA
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto de Medicina Molecular
    B.5.2Functional name of contact pointUnidade Investigação Reumatologia
    B.5.3 Address:
    B.5.3.1Street AddressAv. Prof. Egas Moniz, Edifício Egas Moniz,
    B.5.3.2Town/ cityLisbon
    B.5.3.3Post code1649-028
    B.5.3.4CountryPortugal
    B.5.4Telephone number+35121 7999544
    B.5.5Fax number+35121 7999459
    B.5.6E-mailelsa-sousa@hotmail.com
    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 Simponi
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Biologics B.V.
    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 namegolimumab
    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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.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) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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 injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Psoriatic arthritis
    E.1.1.1Medical condition in easily understood language
    Psoriatic arthritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate differences of efficacy of golimumab in combination MTX in comparison with MTX monotherapy, in improving dactylitis at 24 weeks versus baseline, in MTX naive PsA patients.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of golimumab in combination with MTX versus MTX monotherapy on:
    • enthesitis
    • feet and hands inflammation assessed by MRI
    • peripheral and axial joint involvement
    • skin and nail involvement
    • function
    • composite indexes of disease activity
    • quality of life

    To assess the safety of golimumab in combination with MTX versus MTX monotherapy on:
    • serious and non-serious adverse events
    • immunogenicity of golimumab in association with MTX
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients older than18 years, with the diagnosis of PsA according to CASPAR criteria, established at least 3 months prior to screening, with tender dactylitis, refractory to at least two systemic NSAIDs, at optimal dosage, for 3 months.
    E.4Principal exclusion criteria
    Exclusion criteria are those considered for any antiTNF agent and MTX or that might interfere with trial evaluations or patient’s safety.
    E.5 End points
    E.5.1Primary end point(s)
    -Changes from baseline of the Dactylitis Severity Score (DSS) at 24 weeks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    E.5.2Secondary end point(s)
    - Changes from baseline of the dactylits severity score (DSS) at 12 weeks.
    - Changes from baseline of the Leeds Dactylitis Score (LDI) at 12 and 24 weeks.
    - Proportion of patients achieving DSS20, DSS50 and DSS70 at 12 and 24 weeks.
    - Proportion of patients achieving LDI20, LDI50 and LDI70 at 12 and 24 weeks.
    - Proportion of patient achieving dactylitis remission at 12 and 24 weeks in comparison with baseline
    - Proportion of patients with tender and non tender dactylitis at 12 and 24 weeks in comparison with baseline
    - Changes from baseline of the LEI and SPARCC scores at 12 and 24 weeks.
    - Proportion of patients achieving enthesitis remission, at 12 and 24 weeks comparing with baseline
    - Changes from baseline in psoriatic arthritis MRI scoring system for the wrists and hands (PSAMRIS-H) and for feet and ankle (PSAMRIS-F) at week 24.
    - Changes from baseline of dactylitis MRI score at week 24.
    - Changes from baseline in 68 tender and 66 swollen joint counts at 12 and 24 weeks.
    - Changes from baseline of patient and physician disease activity assessment using visual analogical scales at 12 and 24 weeks.
    - Changes from baseline of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis (AS) Disease Activity Score (ASDAS) at 12 and 24 weeks, in patients with axial involvement.
    - Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 50, 75 and 90 response at 12 and 24 weeks.
    - Changes from baseline in target Nail Psoriasis Severity Index (target NAPSI) score, at week 12 and 24.
    - Changes from baseline in functional indexes Health Assessment Questionnaire Disability Index (HAQ) and Bath Ankylosing Spondylitis Functional Index (BASFI) at 12 and 24 weeks.
    - Changes from baseline in composite indexes Psoriatic Arthritis Disease Activity Score (PASDAS), Composite Psoriatic Disease Activity Index (CPDAI), Disease Activity Index for Psoriatic Arthritis (DAPSA), Disease Activity Score (DAS28), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI) at week 12 and 24.
    - Proportion of patients achieving the American College of Rheumatology (ACR) 20, 50 and 70 response, the Psoriatic Arthritis Response Criteria (PSARC) response, the Psoriatic Arthritis Joint Activity Index (PSAJA)I response, the Assessment of Spondyloarthritis International Society (ASAS) 20 and 40 response and the Ankylosing Spondylitis (AS) Disease Activity Score (ASDAS) clinical important, major ASDAS improvement and inactive disease at 12 and 24 weeks.
    - Changes from baseline in quality of life indexes Medical Outcomes Study Short Form 36 (SF36) and Dermatology Life Quality Index (DLQI) at 12 and 24 weeks.
    - Proportion of participants achieving minimal disease activity (MDA) at 12 and 24 weeks.

    Safety:
    - Number of participants who experience an adverse event
    - Number of participants who develop anti-golimumab antibodies
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 12 and 24 weeks, depending on the endpoint.
    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) 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) No
    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 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
    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 months0
    E.8.9.1In the Member State concerned 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: 120
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 16
    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 state136
    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 will be followed according to regular clinical practice after the ending of the trial. Both MTX and golimumab are available for the treatment of psoriatic arthritis patients.
    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 Decision2013-12-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-06-05
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