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    Summary
    EudraCT Number:2009-011137-26
    Sponsor's Protocol Code Number:P06129
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-13
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2009-011137-26
    A.3Full title of the trial
    An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2).
    A.3.2Name or abbreviated title of the trial where available
    GO-MORE
    A.4.1Sponsor's protocol code numberP06129
    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 SponsorSchering-Plough Research Institute, A Division of Schering Corporation
    B.1.3.4CountryUnited States
    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 Simponi
    D.2.1.1.2Name of the Marketing Authorisation holderCentocor 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 nameGolimumab
    D.3.2Product code SCH 900259
    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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 2
    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
    D.3.2Product code SCH 900259
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGolimumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active Rheumatoid Arthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    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: Assess safety/efficacy of subcutaneous golimumab 50 mg (SC-GLM50), administered once monthly during 6 months, when combined with different DMARD regimens used in rheumatology practice. Subjects to be classified by concomitant treatment and treatment history to investigate the effect of the following factors on EULAR response assessed by the Disease Activity Score using the 28 tender and swollen joint count (DAS28): a. concomitant methotrexate (MTX) dose for subjects; b. concomitant DMARD backgrounds other than MTX; c. concomitant corticosteroids; d. number of failed DMARDs.
    Part 2: Subjects who have responded to treatment in Part 1 (ie, from Baseline to end of Month 6) but have not achieved remission at the end of Month 6, to study whether a strategy of using intravenous GLM at 2 mg/kg body weight (IV-GLM2) to induce remission followed by SC-GLM50 to retain remission is superior to continuing a SC-GLM50 regimen.
    E.2.2Secondary objectives of the trial
    Part 1: 1.Classify subjects by concomitant treatment and treatment history to investigate the following effect on secondary endpoints: concomitant MTX dose, non-MTX DMARD background, corticosteroids and the number of failed DMARDs. 2.Classify subjects by disease markers/characteristics to investigate effect of the following on efficacy endpoints: Baseline disease activity, chronicity, Baseline diagnostic serum markers. 3.Classify subjects by factors not disease/treatment-related to investigate the following effect on all efficacy endpoints: smoking, local guidelines/practices, subject expectations, MD experience/expectations. Part 2 (Compare the following): 1.AUC for DAS28 from end Month 6 to end Month 12 . 2.Time to DAS28-ESR remission between regimens. 3/4.Change in disease activity and subjects achieving low disease activity/remission measured by SDAI, DAS28 and subcomponents between regimens at every visit. 5.Patient-reported outcomes between regimens at every visit.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The subject must fulfill ALL the criteria listed below for entry in Part 1:
    1. Each subject must be willing and able to provide written informed consent for the trial.
    2. Each subject must be ≥18 years of age. A subject may be of either sex, and any race/ethnicity.
    3. Each subject must have a diagnosis of RA according to the 1987 revised American College of Rheumatology (ACR) criteria.
    4. Each subject must have active disease (DAS28-ESR ≥3.2) despite DMARD treatment.
    5. Each subject must still be taking at least one of the allowed DMARDs, at a stable dose for at least one month prior to trial entry, and must be considered capable of maintaining the stable dose during the trial.
    6. Each subject must be eligible for anti-TNF use according to the following criteria:
    a. Subject must have failed conventional treatment according to the investigator’s opinion OR local guidelines.
    b. Local guidelines regarding safety screening of anti-TNF candidates (ie, tuberculosis [TB] screening, specific laboratory tests, and other safety screening such as vaccination, if applicable) must be met. Screening for latent TB must include a chest C-ray and either a skin test or QuantiFERON-Gold test.
    c. The results of the anamnesis and physical examination must make the subject eligible for anti-TNF use and trial participation according to the investigator’s judgment.
    7. Each subject must be able to adhere to dose and visit schedules.
    8. Each female subject or male subject and his female sexual partner of childbearing potential must agree to use a medically accepted method of contraception prior to enrollment, while receiving protocol-specified medication and for 6 months after stopping the medication. Medically accepted methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), inert or coppercontaining IUD, hormone-releasing IUD, systemic hormonal contraceptive, and surgical sterilization (eg, hysterectomy or tubal ligation). Other methods may be used as required by local legislation. Postmenopausal women are not required to use contraception. Postmenopausal is defined as at least 12 consecutive months without a spontaneous menstrual period.

    The subject must fulfill ALL the criteria listed below for entry in Part 2:
    1. Each subject must have been eligible for Part 1 and must have completed Part 1 of this trial.
    2. Each subject must have:
    a. good or moderate DAS28-ESR response to 6 months of SC-GLM50 regimen (ie, response at the end of Month 6 compared to Baseline), AND
    b. no DAS28-ESR remission (ie, DAS28-ESR ≥2.6) at the end of that period.
    3. The trial site must have access to facilities that can perform IV infusions.
    4. Both the investigator and the subject must agree to switch the subject’s treatment to IV administration as required for Arm 1 in Part 2 of this trial.
    5. The investigator must judge that no safety events (eg, serious adverse events [SAEs], serious infections, marked injection-site reactions or intolerance to drug) have occurred that could reoccur or aggravate with increased drug exposure.
    E.4Principal exclusion criteria
    The subject must fulfill ALL the criteria listed below for entry in this trial.
    1. A subject must not have a history of biologic drug use for RA.
    2. A subject must not have evidence of active TB or latent TB that is untreated.
    3. A subject must not have a history of lymphoproliferative disease or any unknown malignancy or history of malignancy within the previous 5 years, with the exception of nonmelanoma skin cancer that has been treated with no evidence of recurrence.
    4. A subject must not have a history of moderate to severe heart failure (NYHA class III/IV) even if medically controlled.
    5. A subject must not have an inflammatory rheumatic disease other than RA that might confound the evaluations of safety and toxicity such as, but not limited to, ankylosing spondylitis and psoriatic arthritis.
    6. A subject must not have any systemic inflammatory condition with signs and symptoms that might confound the evaluations of safety and toxicity from GLM therapy, including, but not limited to:
    a. active Lyme disease,
    b. systemic lupus erythematosus,
    c. infectious or reactive arthritis,
    d. Reiter’s syndrome,
    e. nonrheumatoid vasculitis, or
    f. parvovirus infection.
    7. A subject must not have received any investigational drugs within the 30 days prior to Baseline, and must not receive them during the current trial.
    8. A subject must not have allergy/sensitivity to investigational product(s) or its/their excipients, including latex.
    9. A female subject must not be breast-feeding.
    10. A female subject must not be pregnant or intending to become pregnant.
    11. A subject must not have any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial.
    12. A subject must not be participating in any other interventional clinical trial.
    13. A subject must not be a member or a family member of the personnel of the investigational or sponsor staff directly involved with this trial.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1: the proportion of subjects achieving DAS28-ESR EULAR response.
    Part 2 coprimary efficacy endpoints:
    1. Proportion of subjects who are in DAS28-ESR remission at the start of Month 11 (Visit 10).
    2. Proportion of subjects who are in DAS28-ESR remission at the end of Month 12 (Visit 11).
    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 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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA348
    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 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
    A subject is considered to have completed the trial after he/she has completed all of the protocol-specified visits and activities OR after the last dose of trial medication (ie, in case a subject discontinues prior to the final visit), whichever is later.
    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 months6
    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 months6
    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.1.1.1In 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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2100
    F.4.2.2In the whole clinical trial 3150
    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 Decision2010-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-02-02
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