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    Summary
    EudraCT Number:2018-001085-42
    Sponsor's Protocol Code Number:POISE
    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:2018-05-09
    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 number2018-001085-42
    A.3Full title of the trial
    Clinical effectiveness of symptomatic therapy compared to standard step up care for the treatment of low impact psoriatic oligoarthritis: a 2 arm parallel group feasibility study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    POISE - Psoriatic Oligoarthritis Intervention with Symptomatic thErapy
    A.3.2Name or abbreviated title of the trial where available
    POISE
    A.4.1Sponsor's protocol code numberPOISE
    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 SponsorUniversity of Oxford
    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 supportNIHR
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Oxford
    B.5.2Functional name of contact pointClinical Trials and Research Govern
    B.5.3 Address:
    B.5.3.1Street AddressJoint Research Office,
    B.5.3.2Town/ cityHeadington, Oxford
    B.5.3.3Post codeOX3 7LQ
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailctrg@admin.ox.ac.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 Methylprednisolone acetate BP
    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 nameMethylprednisolone acetate BP
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    Intramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMethylprednisolone acetate BP
    D.3.9.4EV Substance CodeAS1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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.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 Information not present in EudraCT
    D.2.1.1.1Trade name Triamcinolone acetonide
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharmaceuticals Limited
    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 nameTriamcinolone acetonide
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    Intramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTriamcinolone acetonide
    D.3.9.4EV Substance CodeAS2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    Psoriatic Arthritis (PsA) is an inflammatory arthritis. PsA is a highly heterogenous disease with a proportion of participants having mild non-progressive disease. Well validated prognostic factors in PsA can identify these Participants including number of active joints, systemic inflammation levels, radiographic damage and functional ability at presentation. There is little research addressing outcomes and treatment options for mild disease.
    E.1.1.1Medical condition in easily understood language
    Psoriatic arthritis causes inflammation in and around the joints. It usually affects people who already have psoriasis, a skin condition that causes a red, scaly rash.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the feasibility of conducting of a future definitive trial to establish whether a subgroup of participants with mild PsA can be safely and effectively managed without DMARDs.
    The study will assess:
    1. The proportion of participants referred to the PsA clinic who meet the inclusion criteria (with this mild disease phenotype as defined by oligoathritis, no poor prognostic factors and PSAID ≤4)
    2. The proportion of participants willing to consent to the study indicating that they find the intervention acceptable
    3. The proportion of participants not offered DMARD therapy during the 48 week trial period (DMARD therapy will be offered if participants have active disease despite 2 doses of glucocorticoids within a 6 month period)
    E.2.2Secondary objectives of the trial
    To develop the design of a future definitive trial to establish whether a subgroup of patients with mild PsA can be safely and effectively managed without DMARDs.
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    See MONITOR PsA (227909)
    E.3Principal inclusion criteria
    This trial will recruit adult participants with newly diagnosed psoriatic arthritis who have not previously received treatment with synthetic or biological DMARDs for their articular disease. For this trial, only participants with mild disease defined as low disease activity and impact will be eligible (see below.

    •Participants consented to the PsA inception cohort (MONITOR-PsA) and to be approached for alternate interventional therapies.
    •Participants with mild disease as defined by:
    -Oligoarticular disease with <5 active joints at baseline assessment.
    -Low disease activity as defined by a PsA disease activity score (PASDAS) ≤3.2.
    -Low impact of disease as defined a PsA impact of disease (PSAID) ≤4.
    •Participant is willing and able to give informed consent for participation in the trial.
    •Male or female.
    •Aged 18 years or above.
    •Female Participants of child bearing potential and male Participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter if receiving DMARD therapy (excluding sulfasalazine).
    •Participant has clinically acceptable laboratory results within 6 weeks of enrolment:
    o Haemoglobin count > 8.5 g/dL
    o White blood count (WBC) > 3.5 x 109/L
    o Absolute neutrophil count (ANC) > 1.5 x 109/L
    o Platelet count > 100 x 109/L
    o ALT and alkaline phosphatase levels <3 x upper limit of normal
    •In the Investigator’s opinion, is able and willing to comply with all trial requirements.
    •Willing to allow his or her GP and consultant, if appropriate, to be notified of participation in the trial.
    E.4Principal exclusion criteria
    The patient may not enter the trial if ANY of the following apply:
    • ≥1 poor prognostic factors for psoriatic arthritis, from
    o raised C reactive protein (CRP) defined as > 4g/dl for standard non-hsCRP
    o radiographic damage defined as the presence of ≥ 1 erosion on plain radiographs of the hands and feet
    o health assessment questionnaire (HAQ) score > 1
    • Contraindications to non-steroidal anti-inflammatory drugs
    • Previous treatment for articular disease with synthetic DMARDs (including methotrexate, leflunomide or sulfasalazine) or biologic DMARDs (including TNF, IL12/23 or IL17 inhibitor therapies) or targeted synthetic DMARDs (PDE4 of JAK inhibitor therapies).
    • Female patient who is pregnant, breast feeding or planning pregnancy during the course of the trial.
    • Significant renal or hepatic impairment.
    • Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
    • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patients at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.
    • Patients who have participated in another research trial involving an investigational product in the past 12 weeks.
    E.5 End points
    E.5.1Primary end point(s)
    This study is a feasibility study and the primary outcome is to establish the feasibility of a future study addressing this treatment option. Specific feasibility analyses include the calculation of the proportions of:
    • eligible patients in the cohort over the recruitment period for POISE
    • eligible patients consenting into the POISE trial
    • patients/participants requiring escalation to DMARD therapy within the first 48 weeks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This will be evaluated at the end of the feasibility study after 48 weeks participation in the trial. Eligible patients and proportion consenting will be monitored thoughout.
    E.5.2Secondary end point(s)
    The secondary outcome in this study is to investigate the PASDAS response and changes in PASDAS score occurring in the patients within this small feasibility study.

    The primary outcome of the future study will be the proportion of Participants achieving a good response level (reduction from baseline of >1.6 and final score of <3.2) in the PsA Disease Activity Score (PASDAS)[2]. Descriptive data on PASDAS will be collected to allow accurate sample size estimations for any future trial.
    E.5.2.1Timepoint(s) of evaluation of this end point
    This will be evaluated through the data collected at all of the follow-up visits.
    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 Yes
    E.6.13.1Other scope of the trial description
    feasibility of future study
    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 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.8.2.4Number of treatment arms in the trial2
    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 concerned3
    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 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
    LVLS and all data has been entered and queries closed.
    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 months8
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state60
    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)
    Participants will return to the cohort after 48 weeks and be followed up regularly as per standard care. Any treatment which they are receiving at the end of the 48 week trial will be available in routine clinical practice and will be continued without any gap at the end of the study if appropriate.
    It is expected that the patient will remain as part of the cohort for the foreseeable future and will be followed-up annually as part of their routine clinical review.
    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 Decision2018-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-18
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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