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    Summary
    EudraCT Number:2018-004724-11
    Sponsor's Protocol Code Number:STAMP001
    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:2019-07-08
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-004724-11
    A.3Full title of the trial
    Clinical effectiveness of 2 treat to target strategies, mimicking standard care compared to early secukinumab for the treatment of Moderate to Severe Psoriatic Arthritis: a parallel group randomised controlled trial.
    Klinische effectiviteit van 2 treat to target strategieën, standaard therapie vergeleken met secukinumab in een vroege fase, voor de behandeling van matige tot ernstige Artritis Psoriatica: een gerandomiseerd onderzoek met parallele groepen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Strategy Treatments Aiming at Minimal Disease Activity (MDA) in Psoriatic Arthritis
    Behandelstrategiëen gericht op Minimale Ziekte Activiteit (MDA) in Artritis Psoriatica.
    A.3.2Name or abbreviated title of the trial where available
    STAMP
    A.4.1Sponsor's protocol code numberSTAMP001
    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 SponsorErasmus Medical Center
    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 supportNovartis Pharma B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus Medical Center
    B.5.2Functional name of contact pointMarijn Vis
    B.5.3 Address:
    B.5.3.1Street AddressWytemaweg 80
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code1012 TM
    B.5.3.4CountryNetherlands
    B.5.6E-mailmarijn.vis@erasmusmc.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 Cosentyx
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 nameCosentyx
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 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) 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
    Oligo and polyarticular psoriatic arthritis.
    E.1.1.1Medical condition in easily understood language
    Moderate to severe form of joint inflammation affecting individuals with the skin disorder, psoriasis.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    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 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 compare the effectiveness of the administration of secukinumab to standard care in newly diagnosed Psoriatic Arthritis (PsA) patients on the ACR50 response at 6 months.
    E.2.2Secondary objectives of the trial
    To compare effectiveness at 6 and 12 months between two treatment arms, mimicking standard care (arm 1) and early secukinumab arm (arm 2) using:
    - Patients achieving ACR 20 and 70 at 6 months
    - Patients achieving ACR 20, 50, 70 at 12 months
    - Patients achieving MDA and VLDA at 6 and 12 months
    - DAPSA and PASDAS scores at 6 and 12 months

    To compare Quality of life at 12 months between arm 1 and arm 2 using:
    - SF36
    - PSAID
    - BRAF

    To compare work performance (presenteeism and absenteeism) at 12 months between between arm 1 and arm 2.

    To compare progression of radiological damage at 12 months between arm 1 and arm 2 using:
    - PsA modified Sharp vd Heijde (SHS) at 12 months

    To assess the cost-effectiveness between arm 1 and arm 2.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A new diagnosis of PsA as per CASPAR criteria <3 months.
    2. A minimum of two swollen joints.
    3. Patients must be able to understand and communicate with the Investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed.
    4. Male or female patients between 18 and 80 years of age.
    5. In the Investigator’s opinion, the patient is able and willing to comply to all trial requirements.
    6. Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter as in standard practice.
    E.4Principal exclusion criteria
    1. Evidence of ongoing infectious or malignant process obtained within 3 months prior to screening and evaluated by a qualified health care professional.
    2. Current or previous treatment of arthritis with DMARDs (including methotrexate, leflunomide or sulfasalazine) or biologics (including TNF, IL12/23 or IL17 inhibitor therapies)
    3. Use of any investigational drug and/or devices within 4 weeks prior to randomization or a period of five half-lives of the investigational drug, whichever is longer in duration.
    4. Pregnant or nursing (lactating) women, in which pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
    5. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study drug.
    6. Underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions which in the opinion of the Investigator immunocompromises the patient and/or places the patient at unacceptable risk for participation in an immunomodulatory therapy.
    7. Significant medical problems or diseases, including but not limited to the following: uncontrolled hypertension (≥ 160/95 mmHg), congestive heart failure (New York Heart Association status of class III or IV), and uncontrolled diabetes.
    8. History of clinically significant liver disease or liver injury as indicated by abnormal liver function tests (LFT) such as aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/ serum glutamic pyruvic transaminase (ALT/SGPT), alkaline phosphatase, or serum bilirubin. The Investigator should be guided by the following criteria: Any single parameter may not exceed 2 x upper limit of normal (ULN). A single parameter elevated up to and including 2 x ULN should be re-checked once more as soon as possible, and in all cases, at least prior to enrollment/randomization, to rule out laboratory error.
    9. History of renal trauma, glomerulonephritis, or subjects with one kidney only, or a glomerular filtration rate (GFR) < 30 ml/min.
    10. Active systemic infections during the last two weeks (exception: common cold) prior to randomization.
    11. History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection as defined by either a positive PPD skin test or a positive QuantiFERON TB-Gold test untreated or insufficiently treated according to the national guideline.
    12. Known infection with human immunodeficiency virus, hepatitis B or hepatitis C at screening or randomization.
    13. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed
    E.5 End points
    E.5.1Primary end point(s)
    The ACR50 response will be used to determine efficacy. A subject is defined as an ACR50 responder if, and only if, the following three conditions are met:
    1. they have a ≥ 50% improvement in the number of tender joints (based on 68 joints)
    2. they have a ≥ 50% improvement in the number of swollen joints (based on 66 joints)
    3. they have a ≥ 50% improvement in three of the following five domains:
    - Patient’s global assessment of disease activity (measured on a VAS scale, 0-100)
    - Physician’s global assessment of disease activity (measured on a VAS scale, 0-100)
    - Patient’s assessment of PsA pain (measured on a VAS scale, 0-100)
    - Health Assessment Questionnaire – Disability Index (HAQ-DI©) score
    - Acute phase reactant (hsCRP or ESR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    E.5.2Secondary end point(s)
    - ACR20 and ACR70 at 6 months;
    - ACR20/50/70 at 12 months;
    - MDA (The proportion of subjects achieving minimal disease activity,
    which is defined as 5 of the following 7 domains: ≤ 1 tender joint count, ≤ 1 swollen joint count, PASI ≤ 1 or BSA≤3%, patient pain VAS ≤ 15, patient global assessment of disease activity VAS ≤ 20, HAQ-DI ≤ 0.5, tender entheseal points ≤ 1) at 12 months
    - VLDA (Very Low Disease Activity), DAPSA (Disease Activity in PSoriatic Arthritis) and PASDAS (Psoriatic Arthritis Disease Activity Score) at 6 and 12 months;
    - SF-36 (36-item, patient-reported survey of patient health), BRAF (Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire) and PSAID (Psoriatic Arthritis Impact of Disease Questionnaire) at 12 moths;
    - PCQ (Psychological Capital Questionnaire) at 12 months;
    - The PsA-modified Sharp/van der Heijde score (SHS) at 12 months.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - ACR20 and ACR70 at 6 months;
    - ACR20/50/70 at 12 months;
    - MDA, VLDA, DAPSA and PASDAS at 6 and 12 months;
    - SF-36, BRAF and PSAID at 12 moths;
    - PCQ at 12 months;
    - The PsA-modified Sharp/van der Heijde score (SHS) at 12 months.
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 concerned13
    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
    The date of the last visit of the last subject to complete the posttreatment
    follow-up, or the date of receipt of the last data point from
    the last subject that is required for primary, secondary and/or
    exploratory analysis, as prespecified in the protocol, whichever is the
    later date.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 100
    F.1.3Elderly (>=65 years) Yes
    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 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 state120
    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)
    None
    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 Decision2019-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-07
    P. End of Trial
    P.End of Trial StatusOngoing
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