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    The EU Clinical Trials Register currently displays   43931   clinical trials with a EudraCT protocol, of which   7307   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:2005-003525-92
    Sponsor's Protocol Code Number:C0743T10
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-12-20
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2005-003525-92
    A.3Full title of the trial
    A Phase 2, Multicenter, Randomized, Double-blind, Placebo controlled Trial of CNTO 1275, a Fully Human Anti IL 12 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis
    A.4.1Sponsor's protocol code numberC0743T10
    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 SponsorCentocor 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 Information not present in EudraCT
    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 nameCNTO 1275
    D.3.2Product code CNTO 1275
    D.3.4Pharmaceutical form Powder for 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.3.8INN - Proposed INNNot available
    D.3.9.3Other descriptive nameHuman monoclonal antibody (CNTO 1275) to interleukin-12p40, Anti-IL-12; Human anti-IL-12 Mab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboPowder for solution 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
    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
    The primary objective of this study is to evaluate the efficacy and safety of CNTO 1275 in the treatment of subjects with active Psoriatic Arthritis.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate:
    (1) the efficacy of CNTO 1275 in achieving a high level of improvement in arthritis,
    (2) the impact of CNTO 1275 on quality of life,
    (3) the efficacy of CNTO 1275 on psoriatic skin lesions, and
    (4) the pharmacokinetic and pharmacodynamic characteristics of CNTO 1275 in subjects with Psoriatic Arthritis.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    subjects must meet all of the following criteria:

    1. Are 18 years of age or older at time of consent; may be male or female.

    2. Have had a diagnosis of PsA at least 6 months prior to the first administration of study agent.

    3. Have a diagnosis of active PsA at the time of screening and baseline, as defined by:3 or more swollen joints and 3 or more tender joints
    -AND at least one of the following-
    Morning stiffness of ≥ 45 minutes
    C-reactive protein (CRP) ≥ 1.5 mg/dL

    4. Have at least 1 of the PsA subsets: DIP joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis.

    5. Are negative for RF.

    6. Have active plaque psoriasis, with a qualifying target lesion of at least 2 cm in diameter, but not on axilla, inframammary area, or groin.

    7. Women of childbearing potential and all men must be using adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and must agree to continue to use such measures until 12 months after receiving the last injection of study agent.

    8. Are able to adhere to the study visit schedule and other protocol requirements.

    9. Are capable of giving informed consent and the consent must be obtained prior to any study related procedures.

    10. Must avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during study.

    11. Have active arthritis despite current or previous DMARD and/or NSAID therapy, or prior exposure to anti-TNF agents. DMARD therapy is defined as taking a DMARD for at least 3 months, or evidence of DMARD intolerance. NSAID therapy is defined as taking an NSAID for at least 4 weeks.

    12. If using MTX, subjects should have started treatment at least 3 months prior to the first administration of study agent and should have no serious toxic side effects attributable to MTX. MTX route of administration and doses (not to exceed 25 mg/week) should be stable for at least 4 weeks prior to the first administration of study agent. If currently not using MTX, must have not received MTX for at least 4 weeks prior to the first administration of the study agent.

    13. If using NSAIDs, must be on a stable dose for at least 2 weeks prior to the first administration of study agent. If currently not using NSAIDs, must not have received NSAIDs for at least 2 weeks prior to the first administration of the study agent.

    14. 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.

    15. Must agree not to receive a live virus or live bacterial vaccination during the trial or up to 12 months after the last study agent injection.

    16. Must agree not to receive a bacille Calmette-Guerin (BCG) vaccination during the trial or up to 12 months after the last study agent injection.

    17. Have screening laboratory test results within the following parameters:
    a. Hemoglobin ≥ 8.5 g/dL (SI: ≥ 85 g/L)
    b. White blood cells ≥ 3.5 billion/L (SI: ≥ 3.5 billion cells/L)
    c. Neutrophils ≥ 1.5 billion/L (SI: ≥ 1.5 billion cells/L)
    d. Platelets ≥ 100 billion/L (SI: ≥ 100 billion cells/L)
    e. Serum creatinine ≤ 1.5 mg/dL (SI: ≤ 133 micromol/L)
    f. Serum alanine transaminase, aspartate transaminase, and alkaline phosphatase levels must be within 1.5 times the upper limit of normal range

    18. Are considered eligible according to the following TB screening criteria:
    a. Have no history of latent or active TB prior to screening.
    b. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
    c. 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.
    d. Within 1 month prior to the first administration of study agent, either have a negative tuberculin skin test, or have a newly identified positive tuberculin skin test during screening 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.
    e. Have a chest radiograph (both posterior-anterior and lateral views), 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.
    E.4Principal exclusion criteria
    1. Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 12 months after receiving the last administration of study agent.2. Have other inflammatory diseases that might confound the evaluations of benefit of CNTO 1275 therapy, including but not limited to RA, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease.3. Have ever received any therapeutic agent targeted at reducing IL-12 or IL-23, including but not limited to CNTO 1275 and ABT-874.4. Have used any investigational drug within the previous 4 weeks or 5 times the t1/2 of the investigational agent, whichever is longer or 3 months for any biologic of unknown t1/2.5. Have used any biologic within the previous 4 weeks or 5 times the t1/2 of the biologic, whichever is longer.6. Have ever received natalizumab or other agents that target alpha-4-integrin.7. Have ever received rituximab.8. Have received DMARDs other than MTX within 4 weeks prior to the first administration of the study agent.9. Have received leflunomide within 4 weeks prior to the first administration of study agent (irrespective of undergoing a drug elimination procedure), or have received leflunomide within 3 months prior to the first administration of study agent and have not undergone a drug elimination procedure.10. Have received phototherapy or any systemic medications/treatments that could affect psoriasis or PASI evaluation within 4 weeks of the first administration of study agent. 11. Have used topical medications/treatments that could affect psoriasis or PASI evaluation within 2 weeks of the first administration of study agent. Acceptable low-potency corticosteroids include 2.5% concentration or less of hydrocortisone cream or equivalent.12. Have received any systemic immunosuppressives within 4 weeks of the first administration of the study agent.13. Have received intra-articular, intramuscular (IM), or IV corticosteroids, including adrenocorticotropic hormone administered intramuscularly during the 4 weeks prior to the first administration of the study agent.14. Are currently receiving lithium or have received lithium within 4 weeks of the first administration of the study agent.15. Have received, or are expected to receive, any live virus or bacterial vaccination within 3 months before the first administration of study agent, during the trial, or within 12 months after the last administration of study agent.16. Have received, or are expected to receive, a BCG vaccination within 12 months of screening, during the trial, or within 12 months after the last administration of study agent.17. Have a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection, recurrent urinary tract infection, or open, draining, or infected skin wounds or ulcers.18. 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.19. 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.20. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening.21. 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.22. Have or ever had a nontuberculous mycobacterial infection or opportunistic infection.23. Have or have had a herpes zoster infection within 2 months of first administration of study agent.24. Are known to be infected with human immunodeficiency virus, hepatitis B, or hepatitis C.25. Have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease.26. Have a transplanted organ (with exception of a corneal transplant > 3 months prior to the first administration of study agent).27. Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location.28. Have any known malignancy or have a history of malignancy (with the exception of basal cell carcinoma or squamous cell carcinoma in situ of the skin, cervical carcinoma in situ that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to randomization).29. Have been hospitalized in the past 3 years for asthma, ever required intubation for treatment of asthma, currently require chronic oral corticosteroids for the treatment of asthma, or required more than one short-term (≤ 2 weeks) course of oral corticosteroids for asthma within the previous year.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjects who achieve an ACR 20 response at Week 12
    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 Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 months9
    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 months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-12-20. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 140
    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)
    N.A.
    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 Decision2006-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-12-20
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