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    Summary
    EudraCT Number:2013-004122-28
    Sponsor's Protocol Code Number:RR13/10782
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-01-22
    Trial 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 number2013-004122-28
    A.3Full title of the trial
    An investigator‐initiated double‐blind, parallel‐group randomised controlled trial of GOLimumab and Methotrexate versus Methotrexate in very early PsA using clinical and whole body MRI outcomes: the GOLMePsA study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    GOLMePsA
    A.3.2Name or abbreviated title of the trial where available
    GOLMePsA
    A.4.1Sponsor's protocol code numberRR13/10782
    A.5.4Other Identifiers
    Name:R&DNumber:RR13/10782
    Name:REC:Number:14/EM/0124
    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 SponsorThe Leeds Teaching Hospitals NHS Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Biologics
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Leeds Teaching Hospitals NHS Trust
    B.5.2Functional name of contact pointMark Harrison
    B.5.3 Address:
    B.5.3.1Street AddressChapel Allerton Hospital, LIRMM, Level 2
    B.5.3.2Town/ cityLeeds
    B.5.3.3Post codeLS7 4SA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01133924734
    B.5.6E-mailmark.harrison@leedsth.nhs.uk
    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.2.1.1.1Trade name SIMPONI
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Research & Development, LLC
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 pre-filled syringe
    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.3.9.3Other descriptive nameGolimumab
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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) 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 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 placeboSuspension for injection in pre-filled syringe
    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
    Adult patients with a diagnosis of Psoriatic Arthritis(PsA), (Caspar criteria) of less than 24-month duration.
    E.1.1.1Medical condition in easily understood language
    Early Psoriatic Arthritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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 aim of the study is to assess the feasibility of running a clinical trial comparing the efficacy of a treatment strategy in early, treatment naïve PsA patients, using a combination of early TNFi therapy (Golimumab) plus methotrexate plus steroids versus standard care (MTX monotherapy plus steroids) using WB-MRI as an outcome measure.
    E.2.2Secondary objectives of the trial
    • Number (%) of subjects achieving MDA.
    • Number (%) of subjects achieving PsARC, ACR responses and PASDAS disease activity response criteria.
    • Relationship of clinical and imaging (WB-MRI and US) response to the total amount of steroids received by week 12.
    • Relationship between clinical and imaging response and number of swollen and tender joints at baseline.
    • Relationship between clinical response and duration of symptoms at time of presentation.
    • Radiologic outcomes for golimumab + MTX vs MTX monotherapy over a 52 week period in terms of WB-MRI (24 and 36 weeks) and ultrasound assessment of disease activity and joint damage and radiographic joint damage (x-rays).
    • Predictors of early response in terms of WB-MRI and ultrasound over a 12 week period.
    • Predictors of sustained response in terms of ultrasound over a 52 week period.
    • Impact of both treatment strategies in quality of life patient reported outcomes (PsAQoL, EQ-5D, SF-36, DLQI).
    • To determine whether c
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female patients aged ≥18 years at the time of signing the Informed Consent Form.
    2. Subjects with a diagnosis of psoriatic arthritis as per the Classification for Psoriatic Arthritis (CASPAR) criteria (Appendix 4) confirmed less than 24 months prior to screening.
    3. Subjects with active PsA defined as the presence of at least 3/68 tender and at least 3/66 swollen joints or 2 swollen and 2 tender joints plus one affected entheseal site (Achilles tendon and/or plantar fascia) at baseline.
    4. Subjects should have one or more active inflammatory lesions (bone marrow oedema/osteitis/enthesitis or synovitis) on WB-MRI at baseline.
    5. Are treatment naïve to DMARDs.
    6. Are capable of understanding and signing an informed consent form.
    7. Women of childbearing potential or men capable of fathering children must be using adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization) during the study and for 6 months after receiving the last administration of study agent. Female subjects of childbearing potential must test negative for pregnancy. Female subjects must agree to not donate eggs (ova, oocytes) during the study and for 6 months after last dose of study agent. Male subjects must agree to not donate sperm while in the study and for 6 months after last dose of study agent.
    8. Patients fulfilling the following TB criteria:
    8.1. Have no history of latent or active TB prior to screening. An exception is made for subjects with a history of latent TB and documentation of having completed appropriate treatment for latent TB 3 years prior to the first administration of study agent. It is the responsibility of the investigator to verify the adequacy of previous antituberculous treatment and provide appropriate documentation.
    8.2. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
    8.3. Have had no close contact with a person with active TB or, if there has been such a contact, will be referred to a physician specializing in TB to undergo additional evaluation, and if warranted, receive appropriate treatment as if having latent TB prior to or simultaneously with the first administration of study agent.
    8.4. Within 6 weeks prior to the administration of study agent, either have a negative QuantiFERON-TB Gold test result or have a newly identified positive QuantiFERON-TB Gold test result 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.
    8.5. In the event of 2 inderterminate QuantiFERON-TB Gold in-tube tests results, the subjects will be treated as if having latent TB prior or simultaneously with the first administration of study agent.
    8.6. Have a chest radiograph (posterior-anterior view), read by a qualified radiologist, whose diagnostic assessment is consistent with no evidence of current active TB or old inactive TB, and taken within 12 months of the study.
    8.7. Have a screening laboratory test result as follows:
    8.7.1. Hb≥8.5 g/dL or ≥5.3 mmol/L
    8.7.2. White blood cell (WBC) count ≥3.5x103 cells/uL
    8.7.3. Neutrophils ≥1.5 x103 cells/uL
    8.7.4. Platelets ≥100x103 cells/uL
    8.7.5. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels not exceeding 1.5 times the upper limit of normal (UKN) for the central laboratory conducting the test.
    8.7.6. Serum creatinine not exceeding 1.5 mg/dL
    E.4Principal exclusion criteria
    1. Received previous treatment with any DMARDs.
    2. Received previous treatment with Golimumab or other tumour necrosis factor inhibitor (TNFi) or other biologic drugs.
    3. Any chronic inflammatory arthritis diagnosed before 16 years old.
    E.5 End points
    E.5.1Primary end point(s)
    Number of joints/entheses with inflammatory lesions on WB-MRI (bone marrow oedema/osteitis and/or synovitis) present at 24 weeks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    September 2015 - September 2016
    E.5.2Secondary end point(s)
    Number (%) of subjects achieving MDA.

    Number (%) of subjects achieving PsARC, ACR responses and PASDAS disease activity response criteria.

    Relationship of clinical and imaging (WB-MRI and US) response to the total amount of steroids received by week 12.

    Relationship between clinical and imaging response and number of swollen and tender joints at baseline.

    Relationship between clinical response and duration of symptoms at time of presentation.

    Radiologic outcomes for golimumab + MTX vs MTX monotherapy over a 52 week period in terms of WB-MRI (24 and 36 weeks) and ultrasound assessment of disease activity and joint damage and radiographic joint damage (x-rays).

    Predictors of early response in terms of WB-MRI and ultrasound over a 12 week period.

    Predictors of sustained response in terms of ultrasound over a 52 week period.

    Impact of both treatment strategies in quality of life patient reported outcomes (PsAQoL, EQ-5D, SF-36, DLQI).

    To determine whether clinical response is associated with evidence of immunological normalisation, by evaluating changes in immunological markers of inflammation between baseline and weeks 12, 24, 36 and 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    September 2015 - September 2016
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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 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 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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 No
    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
    Last patient last visit.
    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 months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    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: 88
    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 state88
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 88
    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 conventional NHS treatment once they have been through the study. This will mean that if in need of further biologic therapy they will need to be exposed to a second DMARD agent as per NICE guidelines. This may lead to a minimum delay of 3 months to access further biologic therapy.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Leeds Teaching Hospitals NHS Trust
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-23
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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