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    Summary
    EudraCT Number:2013-004583-56
    Sponsor's Protocol Code Number:MK8259-032
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-12-23
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-004583-56
    A.3Full title of the trial
    Golimumab: A Phase 4, UK Open Label, Single arm Study on its Utilization and Impact in Ulcerative Colitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Go-colitis: Golimumab: A Phase 4 UK Study on its Utilisation and Impact in Ulcerative Colitis
    A.3.2Name or abbreviated title of the trial where available
    Go-colitis
    A.4.1Sponsor's protocol code numberMK8259-032
    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 SponsorMSD
    B.1.3.4CountryUnited Kingdom
    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 organisationMSD
    B.5.2Functional name of contact pointAshlin Dunne
    B.5.3 Address:
    B.5.3.1Street AddressHertford Road,
    B.5.3.2Town/ cityHoddesdon
    B.5.3.3Post codeEN11 9BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+353 (0) 86 170 4919
    B.5.5Fax number+44 1992 705241
    B.5.6E-mailashlin.dunne@merck.com
    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 Simponi
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Biologics B.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 nameSimponi
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    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.3.9.1CAS number 476181-74-5
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50 to 200
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative colitis
    E.1.1.1Medical condition in easily understood language
    Inflammatory bowel disease (IBD) that includes characteristic ulcers and/or open sores.
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess how effective the study drug, golimumab, is at maintaining a clinical response in patients with moderate to severe ulcerative colitis. The clinical response will be assessed by partial Mayo score which takes into account number of stools per day, rectal bleeding and a general assessment performed by the doctor.
    E.2.2Secondary objectives of the trial
    •To assess how effective golimumab is at inducing and maintaining a clinical response in patients with moderate to severe ulcerative colitis.
    •To evaluate both the quality of life of UC sufferers and the amount of resource used in managing ulcerative colitis, including the number and length of time spent in hospital.
    •To assess the changes in biological markers of inflammation (C-reactive protein, fecal calprotectin)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject must meet all the criteria listed below to participate in the trial.
    1. Each subject must have moderate-to-severe UC for at least 3 months (as defined by a partial Mayo score of 4 to 9, or full Mayo score of 6 to 12 inclusive at Week 0. If full Mayo is assessed an endoscopic subscore of ≥2 is required).
    2. Each subject must provide written informed consent for the trial.
    3. Each subject must be aged 18 years or over.
    4. If the subject is currently receiving any of the following treatments for UC, they are eligible, providing they are on a stable dose for the required period of time:
    i. Oral 5-amino salicylic acid (5-ASA) compound (e.g. sulfasalazine, mesalamine, olsalazine, balsalazide): stable dose for at least 2 weeks prior to baseline and during the study treatment period.
    ii. Azathioprine / 6-mercaptopurine: stable dose for at least 2 weeks prior to baseline and during the study treatment period.
    iii. Oral corticosteroids (prednisolone ≤30 mg/day or less or equivalent): stable dose for at least 2 weeks prior to baseline.
    5. Each subject must have no evidence of active, or latent, or inadequately treated infection with Mycobacterium tuberculosis (TB).
    6. Each subject must be eligible to start golimumab treatment according to the SmPC.
    7. Each subject must be not have yet recieved anti-TNF therapy.
    8. During the study and for 6 months after receiving the last administration of trial medication, 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.
    9. Each subject must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    A subject meeting any of the exclusion criteria listed below must be excluded from participating in the trial:
    1. The subject displays clinical signs of ischaemic colitis, fulminant colitis or toxic megacolon.
    2. The subject has evidence of pathogenic bowel infection.
    3. The subject has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn’s disease.
    4. The subject has had surgery as a treatment for UC, or is likely to require surgery during the study period.
    5. The subject has UC, which is confined to a proctitis (distal 15 cm or less).
    6. The subject has a current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
    7. The subject has a current immunisation with any live virus vaccine or history of immunization with any live virus vaccine within 3 months of baseline.
    8. A female subject is pregnant or lactating, or planning pregnancy while enrolled in the study.
    9. The subject has received agents that deplete B or T cells (specific immune cells) (eg, rituximab or alemtuzumab) within 12 months prior to study inclusion, or continue to manifest depletion of B or T cells more than 12 months after completion of therapy with lymphocyte-depleting agents.
    10. The subject has received cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil (MMF) within 8 weeks prior to study inclusion.
    11. The subject has used any investigational drugs within 30 days of Screening.
    12. The subject or a family member is among the investigational or sponsor staff directly involved with this trial.
    13. Any other condition which in the opinion of the investigator would make the subject unsuitable for inclusion in the study or contraindications as defined in the SmPC.
    14. The subject has a known hypersensitivity to human immunoglobulin proteins or other components of golimumab
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure for this study is the proportion of subjects with a partial Mayo score response at the end of the maintenance treatment period - week 54.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Final Analysis (Interim analysis may be undertaken if sufficient data are available to support the NICE Multiple Technology Assessment of anti-TNFs, including golimumab, for ulcerative colitis planned for the UK during the period of this study)
    E.5.2Secondary end point(s)
    -Proportion of patients meeting partial Mayo score clinical response criteria at Week 6
    -Proportion of patients in partial Mayo score response at each study visit
    -Proportion of patients in partial Mayo score remission at each study visit
    -Proportion of patients in partial Mayo score reminssion at study completion
    -Change from baseline in IBDQ and EQ-5D at each study visit
    -Change from baseline in CRP and fecal calprotectin
    -Assessment of rates, duration and reasons for hospitalization
    E.5.2.1Timepoint(s) of evaluation of this end point
    Final Analysis (Interim analysis may be undertaken if sufficient data are available to support the NICE Multiple Technology Assessment of anti-TNFs, including golimumab, for ulcerative colitis planned for the UK during the period of this study)
    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 No
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned30
    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 Information not present in EudraCT
    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
    LVLS
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    Patients will revert to standard of care at the end of the study. Upon study completion the treating physician will treat as per standard of care.
    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 Decision2013-12-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-25
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