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    Summary
    EudraCT Number:2006-003398-28
    Sponsor's Protocol Code Number:C0524T17
    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 number2006-003398-28
    A.3Full title of the trial
    A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis
    A.4.1Sponsor's protocol code numberC0524T17
    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.3.9.2Current sponsor codeCNTO148
    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
    Part 1: Dose-ranging

    • To evaluate the dose response of SC golimumab induction regimens in subjects with moderately to severely active UC.
    • To select SC induction regimen(s) of golimumab, based on safety and efficacy, for continued development in Part 2.
    • To provide the target study population to be evaluated in the 1-year golimumab maintenance study (C0524T18, EudraCT 2006-003399-37).

    Part 2: Dose-confirming

    • To evaluate the efficacy of SC induction regimens of golimumab in inducing clinical response in subjects with moderately to severely active UC.
    • To evaluate the safety of SC induction regimens of golimumab in subjects with moderately to severely active UC.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of SC induction regimens of golimumab in inducing clinical remission.
    To evaluate the efficacy of SC induction regimens of golimumab in inducing mucosal healing.
    To evaluate the efficacy of SC induction regimens of golimumab in improving disease-specific health-related quality of life.
    To provide the target study population to be evaluated in the 1-year golimumab maintenance study (C0524T18, EudraCT 2006-003399-37).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Are men or women 18 years of age or older.

    2.Had UC diagnosed prior to screening.

    3.Must either be currently receiving treatment with, or have a history of having failed to respond to, or tolerate, at least 1 of the following therapies: oral corticosteroids, 6-MP, or AZA.

    4.Prior to the screening endoscopy or the subject’s first entry in the Mayo diary cards, several conditions must be met. See page 19 and 20 of the protocol.

    5.Must be ambulatory and have moderately to severely active UC confirmed during the screening sigmoidoscopy by a >_ 2 endoscopy subscore of the Mayo score.

    6.Must have a diagnosis of UC confirmed by a biopsy collected at the screening endoscopy procedure or have a previous biopsy result obtained within the last year that is consistent with the diagnosis of UC.

    7.Have moderately to severely active UC, defined as a baseline (Week 0) Mayo score of 6 to 12, inclusive.

    8.All subjects >_45 years of age, must either have had a colonoscopy to assess for the presence of adenomatous polyps within 5 years of the first administration of study agent or a colonoscopy to assess for the presence of adenomatous polyps at the screening visit. The adenomatous polyps must be removed prior to the first administration of study agent.

    9.All subjects who have had extensive colitis for >_8 years, or disease limited to the left side of the colon for >_10 years, must either have had a colonoscopy to assess the presence of dysplasia within 1 year prior to the first administration of study agent or a colonoscopy to assess the presence of malignancy at the screening visit.

    10.The investigator has discussed with the subject the information contained within the informed consent regarding anti-TNF therapies and the potential risk of cancer, and has reviewed with the subject country-specific guidance (local practice) on cancer screening and the impact of life-style choices (eg, smoking) on the risk of developing cancer.

    11.Are considered eligible according to the specific TB screening criteria. See page 20 and 21 of the protocol.

    12.Have negative stool results for enteric pathogens.

    13.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 at screening and at Week 0.

    14.Have screening detailed laboratory test results. See page 21 of the protocol.

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

    16.Are capable of providing informed consent, which must be obtained prior to any study-related procedures.
    E.4Principal exclusion criteria
    1.Have severe extensive colitis, as defined in protocol.

    2.Have UC limited to the rectum only or to < 20 cm of the colon.

    3.Presence of a stoma.

    4.Presence or history of a fistula.

    5.Require, or required within the 2 months prior to screening, surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage, or other conditions possibly confounding the evaluation of benefit from study agent treatment.

    6.Presence of symptomatic colonic or small bowel obstruction, confirmed by objective radiographic or endoscopic evidence of a stricture with resulting obstruction (dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy).

    7.History of extensive colonic resection (eg, less than 30 cm of colon remaining) that would prevent adequate evaluation of the effect of study agent on clinical disease activity.

    8.History of colonic mucosal dysplasia.

    9.Presence on screening endoscopy of adenomatous colonic polyps, if not removed prior to study entry, or history of adenomatous colonic polyps that were not removed.

    Concomitant or previous medical therapies received:
    10.Have ever received biologic therapy targeted at TNFa (eg, infliximab, etanercept, certolizumab, adalimumab).

    11.Have ever received natalizumab or other agents that target alpha-4-integrin.

    12.Have ever received agents that deplete B cells (eg, rituximab) or T cells (eg, alemtuzumab, visilizumab).

    13.Are receiving oral corticosteroids at a dose of greater than 40 mg of prednisone or its equivalent per day.

    14.Have received cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil (MMF) within 8 weeks prior to first administration of study agent.

    15.Have a known hypersensitivity to human immunoglobulin proteins or other components of golimumab.

    16.Have used any investigational drug within 4 weeks prior to first administration of study agent or within 5 half lives of the investigational agent, whichever is longer.

    17.Have used apheresis (ie, Adacolumn apheresis) within 2 weeks prior to first administration of study agent.

    Infections or predisposition to infections:
    18.Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening.

    19.Have a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection (eg, bronchiectasis), sinusitis, recurrent urinary tract infection (eg, recurrent pyelonephritis, chronic cystitis), an open, draining, or infected skin wound, or an ulcer.

    20.Have immune deficiency syndrome (eg, severe combined immunodeficiency syndrome [SCIDS], T cell deficiency syndromes, B cell deficiency syndromes, and chronic granulomatous disease).

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

    22.Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening.

    23.Have had a nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis) within 6 months prior to screening.

    24.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.

    25.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 6 months after the last administration of study agent.

    26.Have had a serious infection (eg, hepatitis, pneumonia, or pyelonephritis), have been hospitalized for an infection, or have been treated with parenteral antibiotics for an infection within 2 months prior to first administration of study agent. Less serious infections (eg, acute upper respiratory tract infection, simple urinary tract infection) need not be considered exclusionary at the discretion of the investigator.

    Malignancy or increased potential for malignancy:
    27.Presence or history of any malignancy within 5 years of screening (with exception of nonmelanoma skin cancer that has been treated with no evidence of recurrence).

    28.Presence or history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as 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.

    Coexisting medical conditions or past medical history: see page 24 and 25 of the protocol (points 29 until 38).
    E.5 End points
    E.5.1Primary end point(s)
    Part 1: Dose-ranging
    · Change from baseline in the Mayo score at Week 6

    Part 2: Dose-confirming
    · Primary Endpoint: Clinical response at Week 6
    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) Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA62
    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 years2
    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 years2
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 246
    F.4.2.2In the whole clinical trial 676
    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)
    The plan for treatment or care after the subject has ended his/her participation in the trial is a follow up with the study C0524T18, EudraCT 2006-003399-37.
    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 trial2010-10-06
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