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    Summary
    EudraCT Number:2006-003399-37
    Sponsor's Protocol Code Number:C0524T18
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-07-23
    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 ConcernedFrance - ANSM
    A.2EudraCT number2006-003399-37
    A.3Full title of the trial
    A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis
    A.4.1Sponsor's protocol code numberC0524T18
    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 BV
    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 No
    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 Liquid in prefilled syringe
    D.3.2Product code CNTO 148
    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.3.8INN - Proposed INNGolimumab
    D.3.9.3Other descriptive nameHuman Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Ulcerative Colitis (UC)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the efficacy of 2 SC administered regimens of golimumab in maintaining clinical response through Week 54 in subjects with moderately to severely active UC induced into clinical response with golimumab in the induction studies C0524T16 (EudraCT 2006-003397-94) or C0524T17 (EudraCT 2006-003398-28).

    Evaluate the safety of 2 SC administered maintenance regimens of golimumab in subjects with moderately to severely active UC.
    E.2.2Secondary objectives of the trial
    Evaluate the efficacy of golimumab in maintaining clinical remission at Weeks 30 and 54.
    Evaluate the efficacy of golimumab in maintaining mucosal healing at Weeks 30 and 54.
    Evaluate the efficacy of golimumab in maintaining clinical remission at Weeks 30 and 54 for subjects in clinical remission at Week 0.
    Evaluate the efficacy of golimumab in achieving clinical remission and eliminating corticosteroid use at Week 54 among subjects receiving concomitant corticosteroids at Week 0
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have received all study agent administrations and completed the Week 6 Mayo score evaluation in one of the induction studies of golimumab for UC (ie, C0524T16, EudraCT 2006-003397-94 or C0524T17, EudraCT 2006-003398-28).

    2. Are able to complete the Week 0 visit on the same day as the Week 6 visit of the induction study C0524T16 or C0524T17.

    3. During the study and for 6 months after receiving the last administration of study agent, women of childbearing potential or men capable of fathering children must agree to use adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization). Women of childbearing potential must test negative for pregnancy.

    4. Must be able and willing to adhere to the study visit schedule and comply with other protocol requirements.

    5. Are capable of providing informed consent, which must be obtained prior to any study-related procedures.
    E.4Principal exclusion criteria
    1. Had any of the following changes to their concomitant UC medications (ie, oral 5 ASA compounds, oral corticosteroids, 6-MP, AZA, methotrexate [MTX]) since Week 0 of an induction study (C0524T16, EudraCT 2006-003397-94 or C0524T17, EudraCT 2006-003398-28):
    a. an increased dose
    b. initiation of a concomitant UC medication except for dose equivalent substitutions

    2. Have received any of the following therapies since Week 0 of the induction study:
    a. rectal corticosteroid therapy (ie, corticosteroids administered to the rectum or sigmoid colon via foam or enema)
    b. rectal 5-ASA compounds (ie, 5-ASA compounds administered to the rectum or sigmoid colon via foam or enema)
    c. parenteral corticosteroids
    d. pentoxifylline
    e. total parental nutrition (TPN)
    f. antibiotics for the treatment of UC (including but not limited to ciprofloxacin, metronidazole, or rifaximin)
    g. immunomodulatory agents other than 6-MP/AZA or MTX (including but not limited to cyclosporine, mycophenolate mofetil [MMF], tacrolimus, and sirolimus)
    h. immunomodulatory biologic agents (including but not limited to infliximab, anakinra, etanercept, adalimumab, rituximab, natalizumab, visilizumab)
    i. thalidomide or related agents
    j. investigational drugs
    k. apheresis (eg, Adacolumn apheresis)

    3. Have had, in the opinion of the investigator, a clinically significant hypersensitivity reaction in an induction study (C0524T16 or C0524T17).

    4. Have signs and symptoms of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis.

    5. Have signs and symptoms of nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis).

    6. Have had a clinically significant infection (eg, hepatitis, pneumonia, or pyelonephritis) or have received parenteral antibiotics for an infection since Week 0 of an induction study. Less serious infections (eg, acute upper respiratory tract infection, simple urinary tract infection) need not be considered exclusionary at the discretion of the investigator.

    7. Have signs and symptoms of infection with HIV, hepatitis B, or hepatitis C.

    8. Have signs and symptoms of any malignancy.

    9. Have signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphoma or lymphadenopathy of unusual size or location (eg, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic areas), or clinically significant hepatomegaly or splenomegaly.

    10. Have signs and symptoms of CHF, including medically controlled asymptomatic CHF.

    11. Have signs and symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral diseases.

    12. Have signs and symptoms of systemic lupus erythematosus.

    13. Have signs and symptoms of demyelinating disease, such as multiple sclerosis or optic neuritis.

    14. Have undergone a colectomy (partial or total) or an ostomy (ie, temporary colostomy, permanent colostomy, ileostomy, or other enterostomy) since Week 0 of the induction studies (C0524T16 or C0524T17).

    15. Are pregnant or are planning pregnancy (both males and females) within 6 months following the last administration of study agent.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is clinical response through Week 54.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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 Information not present in EudraCT
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA121
    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
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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 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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 503
    F.4.2.2In the whole clinical trial 1350
    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)
    A long term study extension is planned.
    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 Decision2007-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-02-12
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