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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-012265-60
    Sponsor's Protocol Code Number:CNTO1275PSA3002
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-02-26
    Trial results View 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 ConcernedSweden - MPA
    A.2EudraCT number2009-012265-60
    A.3Full title of the trial
    A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled trial of
    Ustekinumab, a Fully Human anti-IL-12/23p40 Monoclonal Antibody,
    Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis Including Those Previously Treated with Biologic Anti-TNFα Agent(s)
    A.3.2Name or abbreviated title of the trial where available
    PSUMMIT II
    A.4.1Sponsor's protocol code numberCNTO1275PSA3002
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen Biologics B.V.
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Stelara
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International N.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 nameustekinumab
    D.3.2Product code CNTO1275
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeustekinumab
    D.3.9.3Other descriptive nameHuman Anti-IL-12 Antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of this study are to evaluate the efficacy of ustekinumab in subjects with active PsA including those previously treated with biologic anti-TNFα agent(s) by assessing the reduction in signs and symptoms of PsA and to evaluate the safety of ustekinumab in this population.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to evaluate the efficacy of ustekinumab in:
    1. Improving physical function;
    2. Improving psoriatic skin lesions; and
    3. Inhibiting the progression of structural damage.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Men or women between 18 and 99 years of age, inclusive.
    • Have had PsA at least 6 months prior to the first administration of study agent.
    • Have a diagnosis of active PsA as defined by:
    – 5 or more swollen joints and 5 or more tender joints at screening and at
    baseline
    -AND-
    – C-reactive protein (CRP) ≥ 0.3 mg/dL at screening.
    • Have at least 1 of the PsA subsets:
    • Have active plaque psoriasis or a documented history of plaque psoriasis.
    • Have active PsA despite current or previous DMARD and/or NSAID therapy.
    • Must have previously:
    – received at least an 8-week dosage regimen of
    etanercept, adalimumab, golimumab, or certolizumab pegol; or
    – received at least a 14-week dosage regimen of
    infliximab; or
    – received less than an 8-week dosage regimen of etanercept, adalimumab,
    golimumab, or certolizumab pegol or less than a 14-week dosage regimen of
    infliximab as described above and have documented intolerance of anti-TNFα
    therapy
    • Women must be:
    – surgically sterile
    or
    – abstinent, or
    – if sexually active, be practicing a highly effective method of birth control
    as local regulations permit, before entry, and must agree to continue to use the
    same method of contraception throughout the study.
    • Women of childbearing potential must have a negative serum β-human chorionic
    gonadotropin pregnancy test at screening; and a negative urine pregnancy
    test at Week 0.
    • Men capable of fathering children must agree to use a double barrier method of birth control (or must have been surgically sterilized) and to not donate
    sperm during the study and for 15 weeks after receiving the last dose of study drug.
    • Are considered eligible according to the following TB screening criteria:
    – Have no history of latent or active TB prior to screening. An exception is made for subjects with prior use of anti-TNFα agent(s) with a history of latent TB and documentation of having completed appropriate treatment for latent TB within 3 years prior to the first administration of study agent. It is the responsibility of the investigator to verify the adequacy of previous antituberculous treatment and provide appropriate documentation.
    – Have no signs or symptoms suggestive of active TB upon medical history
    and/or physical examination.
    – Have had no recent close contact with a person with active TB or, if there has
    been such contact, will be referred to a physician specializing in TB to undergo
    additional evaluation and, if warranted, receive appropriate treatment for latent
    TB prior to or simultaneously with the first administration of study agent.
    – Within 6 weeks prior to the first administration of study agent, have a negative
    QuantiFERON-TB Gold test result or have a newly
    identified positive QuantiFERON-TB Gold test result in which active TB has
    been ruled out and for which appropriate treatment for latent TB
    has been initiated either prior to or simultaneously with the first
    administration of study agent
    – Have a chest radiograph taken
    within 3 months prior to the first administration of study agent and read by a
    qualified radiologist, with no evidence of current, active TB or old, inactive
    TB.
    • If using MTX, subjects should have started treatment at a dose not to exceed
    25 mg/week at least 3 months prior to the first administration of study agent and
    should have no serious toxic side effects attributable to MTX.
    • If using NSAIDs or other analgesics for PsA, must be on a stable dose for at least
    2 weeks prior to the first administration of study agent. If currently not using
    NSAIDs or other analgesics for PsA, must not have received NSAIDs or other
    analgesics for PsA for at least 2 weeks prior to the first administration of the study
    agent.
    If using oral corticosteroids, the subject must be on a stable dose equivalent to
    ≤ 10 mg of prednisone/day for at least 2 weeks prior to the first administration of
    study agent. If currently not using oral corticosteroids, the subject must not have
    received oral corticosteroids for at least 2 weeks prior to the first administration of
    study agent.
    • Must avoid prolonged sun exposure and avoid use of tanning booths or other
    ultraviolet light sources during study.
    • Have screening laboratory test results within the following parameters:
    – Hemoglobin ≥ 8.5 g/dL (SI: ≥ 85 g/L)
    – White blood cells ≥ 3.5 x 103/mL (SI: ≥ 3.5 GI/L)
    – Neutrophils ≥ 1.5 x 103/mL (SI: ≥ 1.5 GI/L)
    – Platelet ≥ 100 x 103/mL (SI: ≥ 100 GI/L)
    – Serum creatinine ≤ 1.5 mg/dL (SI: ≤ 129 mmol/L)
    – AST, ALT, and alkaline phosphatase levels must be within 1.5 times the ULN
    range for the laboratory conducting the test.
    • Willing/able to adhere to the prohibitions and restrictions specified in this protocol
    • Subjects must have signed an informed consent
    E.4Principal exclusion criteria
    • Have other inflammatory diseases that might confound the evaluations of benefit of
    ustekinumab therapy,
    • Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in
    the study or within 15 weeks after receiving the last administration of study agent.
    • Have used any therapeutic agent targeted at reducing IL-12 or IL-23
    Have used any investigational drug within the previous 4 weeks or 5 times the t1/2 of the investigational agent, whichever is longer.
    • Have received infliximab, golimumab, or certolizumab pegol within 12 weeks prior
    to the first administration of the study agent.
    • Have received adalimumab or etanercept within 8 weeks prior to the first
    administration of the study agent.
    • Have received alpha-4 integrin antagonists efalizumab, or agents that deplete B or T cells
    within 12 months of screening, or, if after receiving these agents,
    evidence is available at screening of persistent depletion of the targeted lymphocyte
    population.
    • Have used alefacept within 3 months prior to the first administration of study agent.
    • Have received abatacept.
    • Known allergies, hypersensitivity, or intolerance to ustekinumab or its excipients
    • Have received DMARDs other than MTX
    or anakinra within 4 weeks prior to the first administration of the study agent.
    • Have received leflunomide within 4 weeks prior to the first administration of study
    agent or have received
    leflunomide from 4 to 12 weeks prior to the first administration of study agent and
    have not undergone a drug elimination procedure.
    • Have received any systemic medications/treatments that could affect psoriasis or
    PASI evaluation
    within 4 weeks
    of the first administration of study agent.
    • Have used topical medications/treatments that could affect psoriasis or PASI
    evaluation (including, but not limited to corticosteroids (with the exception of low potency corticosteroids used on the palms, soles, face and/or intertriginous areas), anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, methoxsalen, trimethylpsoralens) within 2 weeks of the first administration of study agent.
    • Have received any systemic immunosuppressives, within 4 weeks of the first administration of the study agent.
    Have received intra-articular, IM, or IV corticosteroids, administered intramuscularly during the 4 weeks prior to the first administration of the study agent.
    • Are currently receiving lithium or have received lithium within 4 weeks of the first
    administration of the study agent.
    • Have received, or are expected to receive, any live virus or bacterial vaccination
    within 3 months prior to the first administration of study agent, during the study, or
    within 12 months after the last administration of study agent.
    • Have a history of chronic or recurrent infectious disease,
    • Have a history of an infected joint prosthesis, or have received antibiotics for a
    suspected infection of a joint prosthesis, if that prosthesis has not been removed or
    replaced.
    • Have had or have a serious infection or
    have been hospitalized or received IV antibiotics for an infection during the 2 months
    prior to screening.
    • Have a history of latent TB or a history of or clinically active granulomatous infection, including TB, histoplasmosis or coccidioidomycosis, prior to screening.
    • Have had a Bacille Calmette-Guérin vaccination within 12 months of
    screening.
    • Have a chest radiograph within 3 months prior to the first administration of study
    agent that shows an abnormality suggestive of a malignancy or current active
    infection, including TB.
    • Have or ever had a nontuberculous mycobacterial infection or opportunistic infection
    • Have indeterminate initial and repeat QuantiFERON-TB Gold test results or a newly
    positive QuantiFERON-TB Gold test and refuses TB prophylaxis
    treatment.
    • Have or have had a herpes zoster infection within 2 months of first administration of study agent.
    • Are known to be infected with HIV, hepatitis B, or hepatitis C.
    • Have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease.
    • Have a transplanted organ
    • Have a known history of lymphoproliferative disease
    • Have any known malignancy or have a history of malignancy
    • Are unable or unwilling to undergo multiple venipunctures
    • Are known to have had a substance abuse problem within the
    previous 12 months.
    • Are participating in another study using an investigational agent or procedure during participation in the study.
    • Are currently receiving venom immunotherapy
    • Any condition that, in the opinion of the investigator, would compromise the wellbeing of the subject or the study or prevent the subject from meeting or performing study requirements
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjects achieving an ACR 20 response at Week 24.
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 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 Yes
    E.8.2.3Other No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The study will end when the last subject completes the Week 60 visit.
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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.1.3Elderly (>=65 years) Yes
    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 state15
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 300
    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)
    Not applicable. The expected normal treatment is available to the 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 Decision2010-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-13
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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