POISE: Psoriatic Oligoarthritis Intervention With Symptomatic thErapy

Sponsor
University of Oxford (Other)
Overall Status
Completed
CT.gov ID
NCT03797872
Collaborator
National Institute for Health Research, United Kingdom (Other)
1
Enrollment
1
Location
2
Arms
15
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

POISE is a two arm interventional trial nested within a cohort (Trials Within Cohorts or TWiCs design). This tests less aggressive early therapy in patients newly diagnosed with low impact oligoarticular PsA. Arm 1 will receive standard step up therapy in the cohort and act as the control group. Arm 2 will receive local steroid injections to active joints and will be able to use non-steroidal anti-inflammatory drugs (NSAIDs) only

Detailed Description

Arm 1: Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard practice in these PsA clinics following current international recommendations and National requirements for the prescription of biologic therapy. Whilst physician discretion is used, most commonly Initial therapy will be with methotrexate alone (15mg/week rising to 25mg/week as tolerated by week 8 of therapy) unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (most commonly sulfasalazine or leflunomide) added or switched to at the discretion of the rheumatologist. In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations usually with a TNF inhibitor as first line. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used. Further details are available in the PsA clinic treatment protocol which is Appendix D in the MONITOR-PsA protocol.

Arm 2: Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local glucocorticoid injections to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication as indicated for individuals. Local glucocorticoid injections will include injections with methylprednisolone or triamcinolone. All active joints will be treated with glucocorticoid injections. Glucocorticoid injections can be either be given as an intra-articular injection to an inflamed joint or as an intra-muscular injection if multiple joints are involved. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy). If Participants require DMARD therapy, they will be offered rescue therapy as per usual clinical care but will be asked to continue with data collection for the trial. This is to ensure that sufficient data is collected for the trial but risks in delaying treatment to the individual are mitigated.

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Blinded assessor will perform clinical evaluations
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Apr 17, 2019
Actual Primary Completion Date :
Jul 16, 2020
Actual Study Completion Date :
Jul 16, 2020

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Standard care

Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.

Drug: Methotrexate
Methotrexate up to 25mg/week as tolerated po or sc
Other Names:
  • methotrexate sodium
  • Drug: Sulfasalazine
    Sulfasalazine up to 3g daily po
    Other Names:
  • sulfasalazine pill
  • Drug: Leflunomide
    Leflunomide 10-20mg daily po
    Other Names:
  • leflunomide pill
  • Experimental: Local/IM steroid injections

    Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).

    Drug: Methylprednisolone
    For IA or IM injection 20-120mg
    Other Names:
  • methylprednisolone acetate
  • Drug: Triamcinolone
    For IA or IM injection 20-120mg
    Other Names:
  • triamcinolone acetonide
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study [48 weeks]

      To establish acceptability of this treatment approach assessing proportion of patients who are eligible, consent and complete the 48 week study. We will examine how many patients in the MONITOR cohort are eligible per year. All eligible patients in the MONITOR cohort will be approached and invited to join the study. We will then review how many patients complete the 48 week study period attending all visits from baseline to 48 weeks (0, 12, 24, 36 and 48).

    Secondary Outcome Measures

    1. Psoriatic Arthritis Disease Activity Score (PASDAS) [48 weeks]

      A composite measure of PsA disease activity. This score is a composite measure of disease activity in PsA. There is only one total score which ranges from 0-10 with higher numbers indicating more active disease. Low disease activity is defined as <3.2.

    2. Ultrasound Score of Synovitis [0 weeks]

      A summary score of synovitis measured at baseline. The score will comprise of 23 joints bilaterally. Grey scale synovitis is scored at each site 0-3 and power doppler is also scored 0-3 at each site where higher scores indicate more severe disease. These scores are then summed to give a final score. Score range is 0-276

    3. Ultrasound Score of Enthesitis [0 weeks]

      A summary score of enthesitis measured at baseline. The score will comprise of 5 entheses bilaterally. Power doppler is scored 0-3 at each site where higher scores indicate more severe disease activity. Calcifications, enthesophytes and grey scale abnormalities will each be score 0 (absent) or 1 (present) at each site. These scores are then summed to give a final score. Score range is 0-30

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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 (defined as true abstinence, oral contraceptives, implants, intrauterine device, barrier method with spermicide, or surgical sterilization) 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:

    • Haemoglobin count > 8.5 g/dL

    • White blood count (WBC) > 3.5 x 109/L

    • Absolute neutrophil count (ANC) > 1.5 x 109/L

    • Platelet count > 100 x 109/L

    • 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.

    Exclusion Criteria:
    • ≥1 poor prognostic factors for psoriatic arthritis, from

    • raised C reactive protein (CRP) defined as > 4g/dl for standard non-hsCRP

    • radiographic damage defined as the presence of ≥ 1 erosion on plain radiographs of the hands and feet

    • 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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Oxford University Hospitals NHS TrustOxfordOxfordshireUnited KingdomOX3 7LD

    Sponsors and Collaborators

    • University of Oxford
    • National Institute for Health Research, United Kingdom

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Oxford
    ClinicalTrials.gov Identifier:
    NCT03797872
    Other Study ID Numbers:
    • 18/SC/0261
    First Posted:
    Jan 9, 2019
    Last Update Posted:
    May 10, 2021
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment DetailsThe POISE trial opened on 17 April 2019 in Oxford and 19 September 2019 in Bath. The study remained open until 16 July 2020 as planned.
    Pre-assignment Detail
    Arm/Group TitleStandard CareLocal/IM Steroid Injections
    Arm/Group DescriptionControl 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used. Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc Sulfasalazine: Sulfasalazine up to 3g daily po Leflunomide: Leflunomide 10-20mg daily poSymptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy). Methylprednisolone: For IA or IM injection 20-120mg Triamcinolone: For IA or IM injection 20-120mg
    Period Title: Overall Study
    STARTED10
    COMPLETED00
    NOT COMPLETED10

    Baseline Characteristics

    Arm/Group TitleStandard CareLocal/IM Steroid InjectionsTotal
    Arm/Group DescriptionControl 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used. Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc Sulfasalazine: Sulfasalazine up to 3g daily po Leflunomide: Leflunomide 10-20mg daily poSymptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy). Methylprednisolone: For IA or IM injection 20-120mg Triamcinolone: For IA or IM injection 20-120mgTotal of all reporting groups
    Overall Participants101
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    NaN
    0
    0%
    Between 18 and 65 years
    1
    100%
    0
    NaN
    1
    100%
    >=65 years
    0
    0%
    0
    NaN
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    NaN
    0
    0%
    Male
    1
    100%
    0
    NaN
    1
    100%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    Region of Enrollment (participants) [Number]
    United Kingdom
    1
    100%
    1
    Infinity

    Outcome Measures

    1. Primary Outcome
    TitleNumber of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study
    DescriptionTo establish acceptability of this treatment approach assessing proportion of patients who are eligible, consent and complete the 48 week study. We will examine how many patients in the MONITOR cohort are eligible per year. All eligible patients in the MONITOR cohort will be approached and invited to join the study. We will then review how many patients complete the 48 week study period attending all visits from baseline to 48 weeks (0, 12, 24, 36 and 48).
    Time Frame48 weeks

    Outcome Measure Data

    Analysis Population Description
    All participants included
    Arm/Group TitleStandard CareLocal/IM Steroid Injections
    Arm/Group DescriptionControl 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used. Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc Sulfasalazine: Sulfasalazine up to 3g daily po Leflunomide: Leflunomide 10-20mg daily poSymptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy). Methylprednisolone: For IA or IM injection 20-120mg Triamcinolone: For IA or IM injection 20-120mg
    Measure Participants10
    Count of Participants [Participants]
    0
    0%
    2. Secondary Outcome
    TitlePsoriatic Arthritis Disease Activity Score (PASDAS)
    DescriptionA composite measure of PsA disease activity. This score is a composite measure of disease activity in PsA. There is only one total score which ranges from 0-10 with higher numbers indicating more active disease. Low disease activity is defined as <3.2.
    Time Frame48 weeks

    Outcome Measure Data

    Analysis Population Description
    Only one patient was recruited and he was lost to follow up before 48 weeks thus these data are not available for analysis
    Arm/Group TitleStandard CareLocal/IM Steroid Injections
    Arm/Group DescriptionControl 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used. Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc Sulfasalazine: Sulfasalazine up to 3g daily po Leflunomide: Leflunomide 10-20mg daily poSymptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy). Methylprednisolone: For IA or IM injection 20-120mg Triamcinolone: For IA or IM injection 20-120mg
    Measure Participants00
    3. Secondary Outcome
    TitleUltrasound Score of Synovitis
    DescriptionA summary score of synovitis measured at baseline. The score will comprise of 23 joints bilaterally. Grey scale synovitis is scored at each site 0-3 and power doppler is also scored 0-3 at each site where higher scores indicate more severe disease. These scores are then summed to give a final score. Score range is 0-276
    Time Frame0 weeks

    Outcome Measure Data

    Analysis Population Description
    Only one patient was recruited and he was lost to follow up before 48 weeks thus these data are not available for analysis
    Arm/Group TitleStandard CareLocal/IM Steroid Injections
    Arm/Group DescriptionControl 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used. Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc Sulfasalazine: Sulfasalazine up to 3g daily po Leflunomide: Leflunomide 10-20mg daily poSymptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy). Methylprednisolone: For IA or IM injection 20-120mg Triamcinolone: For IA or IM injection 20-120mg
    Measure Participants00
    4. Secondary Outcome
    TitleUltrasound Score of Enthesitis
    DescriptionA summary score of enthesitis measured at baseline. The score will comprise of 5 entheses bilaterally. Power doppler is scored 0-3 at each site where higher scores indicate more severe disease activity. Calcifications, enthesophytes and grey scale abnormalities will each be score 0 (absent) or 1 (present) at each site. These scores are then summed to give a final score. Score range is 0-30
    Time Frame0 weeks

    Outcome Measure Data

    Analysis Population Description
    Only one patient was recruited and he was lost to follow up before 48 weeks thus these data are not available for analysis. The US was not performed as this was only for participants in the intervention group.
    Arm/Group TitleStandard CareLocal/IM Steroid Injections
    Arm/Group DescriptionControl 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used. Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc Sulfasalazine: Sulfasalazine up to 3g daily po Leflunomide: Leflunomide 10-20mg daily poSymptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy). Methylprednisolone: For IA or IM injection 20-120mg Triamcinolone: For IA or IM injection 20-120mg
    Measure Participants00

    Adverse Events

    Time Frame48 week study
    Adverse Event Reporting Description 48 week study
    Arm/Group TitleStandard CareLocal/IM Steroid Injections
    Arm/Group DescriptionControl 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used. Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc Sulfasalazine: Sulfasalazine up to 3g daily po Leflunomide: Leflunomide 10-20mg daily poSymptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy). Methylprednisolone: For IA or IM injection 20-120mg Triamcinolone: For IA or IM injection 20-120mg
    All Cause Mortality
    Standard CareLocal/IM Steroid Injections
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/1 (0%) 0/0 (NaN)
    Serious Adverse Events
    Standard CareLocal/IM Steroid Injections
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/1 (0%) 0/0 (NaN)
    Other (Not Including Serious) Adverse Events
    Standard CareLocal/IM Steroid Injections
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/1 (0%) 0/0 (NaN)

    Limitations/Caveats

    Only 1 participants was eligible and participated in the trial during the recruitment period and this patient was lost to follow up after the baseline visit.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleProfessor Laura Coates
    OrganizationUniversity of Oxford
    Phone+447870257823
    Emaillaura.coates@ndorms.ox.ac.uk
    Responsible Party:
    University of Oxford
    ClinicalTrials.gov Identifier:
    NCT03797872
    Other Study ID Numbers:
    • 18/SC/0261
    First Posted:
    Jan 9, 2019
    Last Update Posted:
    May 10, 2021
    Last Verified:
    Mar 1, 2020