<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04482335</url>
  </required_header>
  <id_info>
    <org_study_id>281253</org_study_id>
    <nct_id>NCT04482335</nct_id>
  </id_info>
  <brief_title>PRECISion medicinE Across the Disease Continuum to Prevent and Treat Rheumatoid Arthritis</brief_title>
  <acronym>PRECISE-RA</acronym>
  <official_title>PRECISion medicinE Across the Disease Continuum to Prevent and Treat Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manchester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Manchester</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will recruit patients referred to the Rheumatology Out-patient departments.&#xD;
      Patients will be recruited to the study or control groups (healthy or disease controls who&#xD;
      will be age and sex-matched) as needed. The study will first open to recruitment at&#xD;
      Manchester University Hospitals NHS Foundation Trust and then open at other NHS Trusts.&#xD;
      Patients will be asked to participate in longitudinal (clinical/imaging/biosample) data&#xD;
      and/or sample collection that will improve our understanding of underlying disease mechanisms&#xD;
      and identify improved diagnostic, prognostic and predictive biomarkers to understand&#xD;
      progression of disease and drug response or resistance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Main Study&#xD;
&#xD;
      Consent to this ethics' main programme will permit collection of routinely collected data and&#xD;
      use for research activities. Patients may be recruited at any point along their disease&#xD;
      continuum (e.g. time of initial diagnosis, before/after a new treatment intervention, at time&#xD;
      of disease flare or stable state).&#xD;
&#xD;
      Patients with established disease who are recruited to the study during their follow up&#xD;
      appointments will have pre-existing results and clinical documentation. These retrospective&#xD;
      data may also be collected where possible using information documented in case-notes and/or&#xD;
      hospital information systems.&#xD;
&#xD;
      Some study-specific information will also be collected.&#xD;
&#xD;
      In addition to the main study, participants will be offered the opportunity to consent to&#xD;
      participate in one or more sub-studies which include the additional research procedures&#xD;
      (entitled 'basic biological' and 'synovial biopsy'). It will be possible for patients to&#xD;
      participate in more than one sub-study.&#xD;
&#xD;
      The sub-studies aim to explore the mechanisms that may underlie change over the disease&#xD;
      continuum, not just at disease initiation. In particular, the researchers would wish to&#xD;
      obtain samples and imaging that coincide with a change in disease profile as well as with&#xD;
      loss of disease control. Acquiring pre- and post-treatment blood/tissue samples and images&#xD;
      would allow the investigation of changes in disease pathogenesis, the role of specific&#xD;
      therapies, and identification of treatment response indicators. The researchers would&#xD;
      therefore ask the permission of some individuals to obtain samples or images at additional&#xD;
      time-points to coincide with events along their disease continuum.&#xD;
&#xD;
      Basic Biological sub-study&#xD;
&#xD;
      This sub-study will facilitate identification of prognostic markers of disease, mechanism and&#xD;
      predictive markers of drug response. As part of an in-house investigation of biomarkers and&#xD;
      mechanisms, DNA, serum, plasma, synovial joint fluid, and urine may be collected and stored.&#xD;
      Patients will have the opportunity to consent separately to the genetic (DNA) component.&#xD;
&#xD;
      A maximum of 75mls of blood may be taken to enable the range of experimental studies. The&#xD;
      samples will be taken at relevant clinical time points related to diagnosis, disease profile,&#xD;
      disease activity state and/or treatment related time points; thus samples may be taken at one&#xD;
      time point or repeated depending on the individual study objective and status of the patient.&#xD;
&#xD;
      Synovial biopsy sub-study&#xD;
&#xD;
      Patients will be asked to consent to a synovial biopsy of an affected joint to provide&#xD;
      synovial tissue for research purposes. Synovial joint fluid may also be collected as part of&#xD;
      the biopsy procedure. This will be performed by a trained clinician within our department by&#xD;
      ultrasound-guidance. Depending on the research question being addressed, biopsy may be taken&#xD;
      at time of diagnosis; or before and after starting a new drug treatment; or at time of a&#xD;
      change in disease activity/flare (that may/may not lead to change in therapy). If repeat&#xD;
      biopsy is taken, this is typically 3 or 6 months after starting a new therapy; or may be a&#xD;
      later time point if evaluating for change in disease characteristics and tissue biology over&#xD;
      time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 15, 2021</start_date>
  <completion_date type="Anticipated">October 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>• Main study - Change in Disease Activity Score in 28 Joints (DAS28)</measure>
    <time_frame>through to study completion, an average of 2 years</time_frame>
    <description>• The Disease Activity Score (DAS) assessment is a derived measurement with differential weight given to each component. The DAS28 is calculated at every visit. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment (0-100). The components of the DAS28 CRP score assessment are: Tender/Painful Joint Count (28); Swollen Joint Count (28), CRP, and the Subject General Health VAS assessment (0-100). The DAS score ranges from 0-10 and higher scores indicate high disease activity. A DAS28 value of &gt;5.1 indicates high disease activity, 3.2 &lt;DAS28 ≤5.1 and DAS28 ≤3.2 are defined as moderate and low disease activity. Patients may be considered to be in remission phase if DAS28 is &lt;2.6</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• Biosample substudy - Change in serum biomarkers, gene expression and the distribution of cell populations in biological samples (peripheral blood, synovial fluid, urine) using ELISA, sequencing, flow cytometry and CyTOF</measure>
    <time_frame>through to study completion, an average of 2 years</time_frame>
    <description>• Biosample substudy - Change in serum biomarkers, gene expression and the distribution of cell populations in biological samples (peripheral blood, synovial fluid, urine) using ELISA, sequencing, flow cytometry and CyTOF</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• Synovial biopsy substudy - Changes in immunological markers of inflammation in synovial tissue</measure>
    <time_frame>Baseline +/- week 12 or 24 after change in therapy</time_frame>
    <description>• Synovial biopsy substudy - Changes in immunological markers of inflammation in synovial tissue</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>• Change in Patient reported outcome measure - Rheumatoid Arthritis Quality of Life (RAQoL)</measure>
    <time_frame>through to study completion, an average of 2 years</time_frame>
    <description>• The RAQoL questionnaire consists of 30 items. The overall score is the sum of individual item scores, with a lower score indicating better QoL (range 0-30)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Change in Patient reported outcome measure - Health Assessment Questionnaire (HAQ)</measure>
    <time_frame>through to study completion, an average of 2 years</time_frame>
    <description>• The HAQ questions are assessed on a 4-point Likert scale (0 = without difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Total HAQ score ranges from 0-3.0 in increments of 0.125. Higher scores indicate worse functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Change in Patient reported outcome measure - EuroQoL (EQ-5D)</measure>
    <time_frame>through to study completion, an average of 2 years</time_frame>
    <description>• The EQ-5D consists of 5 domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) rated on a 3 level scale (no problems, some or moderate problems, extreme problems). Rated levels are coded as number 1, 2 or 3 and reported as a five-digit number ranging from 11111 (no problems in all domains) to 55555 (extreme problems in all domains)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Change in Patient reported outcome measure - Functional Assessment of Chronic Illness Therapy - fatigue (FACIT-fatigue)</measure>
    <time_frame>through to study completion, an average of 2 years</time_frame>
    <description>• FACIT-fatigue is a 13-item instrument measure of fatigue scored on a 0-4 response scale. All items are summed to create a final score (range 0-52). Higher scores indicate greater fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Change in Patient reported outcome measure - Hospital Anxiety and Depression Scale (HADs)</measure>
    <time_frame>through to study completion, an average of 2 years</time_frame>
    <description>• HADs consists of two subscales (anxiety and depression) with a total of 14 items - each scored on a scale from 0 to 3. Total scores range from 0-21 for each subscale (0-7 = normal, 9-10 = borderline abnormal, 11-21 = abnormal)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Change in Patient-completed visual analogue scales - pain (VAS-pain)</measure>
    <time_frame>through to study completion, an average of 2 years</time_frame>
    <description>• VAS-pain measures pain on the day on a visual analogue scale (range 0-100) with higher scores indicating worse pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Change in Patient-completed visual analogue scales - disease activity (VAS-DA)</measure>
    <time_frame>through to study completion, an average of 2 years</time_frame>
    <description>• VAS-DA measures the state of arthritis (swelling and stiffness) on the day on a visual analogue scale (range 0-100) with higher scores indicating extremely active arthritis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Change in Patient-completed visual analogue scales - fatigue (VAS-fatigue)</measure>
    <time_frame>through to study completion, an average of 2 years</time_frame>
    <description>•VAS-fatigue measures overall fatigue on the day on a visual analogue scale (range 0-100) with higher scores indicating worse fatigue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Change in Patient-completed visual analogue scales - general health (VAS-GH)</measure>
    <time_frame>through to study completion, an average of 2 years</time_frame>
    <description>• VAS-GH measures general state of health on the day on a visual analogue scale (range 0-100) with higher scores indicating poor state of health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Change in Physician-completed visual analogue scale of disease activity</measure>
    <time_frame>through to study completion, an average of 2 years</time_frame>
    <description>• Physician-completed visual analogue scale of disease activity measures disease activity as rated by the physician on a visual analogue scale (range 0-100) with higher scores indicating extremely active disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Change in joint damage as measured by conventional radiography of hands and feet</measure>
    <time_frame>through to study completion, an average of 2 years</time_frame>
    <description>• Change in joint damage as measured by conventional radiography of hands and feet</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Change from baseline in Ultrasound (US) synovitis as measured by Power Doppler Ultrasound (PDUS)</measure>
    <time_frame>through to study completion, an average of 2 years</time_frame>
    <description>• Change from baseline in Ultrasound synovitis as measured by Power Doppler Ultrasound (PDUS)</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Main Study</arm_group_label>
    <description>Participants complete questionnaires and agree to have their retrospective and prospective medical data used as part f this research project. All participants will take part in this arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biosample Sub-Study</arm_group_label>
    <description>A subset of the participants will take part of this. Participants will agree to have blood samples taken at regular intervals or at the point of a flare or when their treatment changes. They might also be asked to provide urine samples.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Synovial Biopsy and Synovial Fluid Sub-Study</arm_group_label>
    <description>A subset of the participants will take part of this. Participants will agree to synovial biopsies at regular intervals or at the point of a flare or when their treatment changes. They might also be asked to donate waste synovial fluid.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention</description>
    <arm_group_label>Biosample Sub-Study</arm_group_label>
    <arm_group_label>Main Study</arm_group_label>
    <arm_group_label>Synovial Biopsy and Synovial Fluid Sub-Study</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      A maximum of 75mls of blood may be taken to enable the range of experimental studies.&#xD;
&#xD;
      The blood may be drawn into a combination of EDTA, lithium heparin, red clotted, citrate and&#xD;
      PAXGENE/TEMPUS tubes, according to planned experiments at each time point. Samples will be&#xD;
      collected fasting at specific timepoints if indicated.&#xD;
&#xD;
      Similarly, synovial fluid may also be aspirated from a clinically inflamed joint (usually as&#xD;
      part of clinical indication), and used for research purpose. Urine samples may also be&#xD;
      collected (usually as part of clinical indication), and used for research purpose.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        People with early rheumatoid arthritis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Subject ≥ 18 years of age&#xD;
&#xD;
          2. Is capable of understanding and signing an informed consent form&#xD;
&#xD;
          3. Falls into one of the following:&#xD;
&#xD;
               1. Pre-RA - Any musculoskeletal symptom (inflammatory and/or non-inflammatory) AND&#xD;
                  either RF and/orACPA positive.&#xD;
&#xD;
               2. UA - Inflammatory joint symptoms (including joint pain, significant early morning&#xD;
                  stiffness and joint swelling) not fulfilling any classification criteria&#xD;
&#xD;
               3. ERA - recent clinical diagnosis of RA EstRA - known diagnosis of RA supported by&#xD;
                  evidence of established inflammatory arthritis including but not limited to&#xD;
                  synovitis, erosion, tenosynovitis.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Age less than 18 years&#xD;
&#xD;
          2. Lack of capacity to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Manchester Royal Infirmary</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maya H Buch, MD PhD</last_name>
      <phone>+44 (0)161 306 0539</phone>
      <email>maya.buch@manchester.ac.uk</email>
    </contact>
    <contact_backup>
      <last_name>Rudresh Shukla</last_name>
      <phone>+44 (0)161 306 0539</phone>
      <email>rudresh.shukla@manchester.ac.uk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>April 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manchester</investigator_affiliation>
    <investigator_full_name>Prof. Maya H. Buch</investigator_full_name>
    <investigator_title>Clinical Professor of Rheumatology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04482335
org study id: 281253
nct id: NCT04482335
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will recruit patients referred to the Rheumatology Out-patient departments.
      Patients will be recruited to the study or control groups (healthy or disease controls who
      will be age and sex-matched) as needed. The study will first open to recruitment at
      Manchester University Hospitals NHS Foundation Trust and then open at other NHS Trusts.
      Patients will be asked to participate in longitudinal (clinical/imaging/biosample) data
      and/or sample collection that will improve our understanding of underlying disease mechanisms
      and identify improved diagnostic, prognostic and predictive biomarkers to understand
      progression of disease and drug response or resistance.
Main Study

      Consent to this ethics' main programme will permit collection of routinely collected data and
      use for research activities. Patients may be recruited at any point along their disease
      continuum (e.g. time of initial diagnosis, before/after a new treatment intervention, at time
      of disease flare or stable state).

      Patients with established disease who are recruited to the study during their follow up
      appointments will have pre-existing results and clinical documentation. These retrospective
      data may also be collected where possible using information documented in case-notes and/or
      hospital information systems.

      Some study-specific information will also be collected.

      In addition to the main study, participants will be offered the opportunity to consent to
      participate in one or more sub-studies which include the additional research procedures
      (entitled 'basic biological' and 'synovial biopsy'). It will be possible for patients to
      participate in more than one sub-study.

      The sub-studies aim to explore the mechanisms that may underlie change over the disease
      continuum, not just at disease initiation. In particular, the researchers would wish to
      obtain samples and imaging that coincide with a change in disease profile as well as with
      loss of disease control. Acquiring pre- and post-treatment blood/tissue samples and images
      would allow the investigation of changes in disease pathogenesis, the role of specific
      therapies, and identification of treatment response indicators. The researchers would
      therefore ask the permission of some individuals to obtain samples or images at additional
      time-points to coincide with events along their disease continuum.

      Basic Biological sub-study

      This sub-study will facilitate identification of prognostic markers of disease, mechanism and
      predictive markers of drug response. As part of an in-house investigation of biomarkers and
      mechanisms, DNA, serum, plasma, synovial joint fluid, and urine may be collected and stored.
      Patients will have the opportunity to consent separately to the genetic (DNA) component.

      A maximum of 75mls of blood may be taken to enable the range of experimental studies. The
      samples will be taken at relevant clinical time points related to diagnosis, disease profile,
      disease activity state and/or treatment related time points; thus samples may be taken at one
      time point or repeated depending on the individual study objective and status of the patient.

      Synovial biopsy sub-study

      Patients will be asked to consent to a synovial biopsy of an affected joint to provide
      synovial tissue for research purposes. Synovial joint fluid may also be collected as part of
      the biopsy procedure. This will be performed by a trained clinician within our department by
      ultrasound-guidance. Depending on the research question being addressed, biopsy may be taken
      at time of diagnosis; or before and after starting a new drug treatment; or at time of a
      change in disease activity/flare (that may/may not lead to change in therapy). If repeat
      biopsy is taken, this is typically 3 or 6 months after starting a new therapy; or may be a
      later time point if evaluating for change in disease characteristics and tissue biology over
      time.
observational model: Cohort
time perspective: Prospective
measure: • Main study - Change in Disease Activity Score in 28 Joints (DAS28)
time frame: through to study completion, an average of 2 years
description: • The Disease Activity Score (DAS) assessment is a derived measurement with differential weight given to each component. The DAS28 is calculated at every visit. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment (0-100). The components of the DAS28 CRP score assessment are: Tender/Painful Joint Count (28); Swollen Joint Count (28), CRP, and the Subject General Health VAS assessment (0-100). The DAS score ranges from 0-10 and higher scores indicate high disease activity. A DAS28 value of >5.1 indicates high disease activity, 3.2 <DAS28 ≤5.1 and DAS28 ≤3.2 are defined as moderate and low disease activity. Patients may be considered to be in remission phase if DAS28 is <2.6
measure: • Biosample substudy - Change in serum biomarkers, gene expression and the distribution of cell populations in biological samples (peripheral blood, synovial fluid, urine) using ELISA, sequencing, flow cytometry and CyTOF
time frame: through to study completion, an average of 2 years
description: • Biosample substudy - Change in serum biomarkers, gene expression and the distribution of cell populations in biological samples (peripheral blood, synovial fluid, urine) using ELISA, sequencing, flow cytometry and CyTOF
measure: • Synovial biopsy substudy - Changes in immunological markers of inflammation in synovial tissue
time frame: Baseline +/- week 12 or 24 after change in therapy
description: • Synovial biopsy substudy - Changes in immunological markers of inflammation in synovial tissue
measure: • Change in Patient reported outcome measure - Rheumatoid Arthritis Quality of Life (RAQoL)
time frame: through to study completion, an average of 2 years
description: • The RAQoL questionnaire consists of 30 items. The overall score is the sum of individual item scores, with a lower score indicating better QoL (range 0-30)
measure: • Change in Patient reported outcome measure - Health Assessment Questionnaire (HAQ)
time frame: through to study completion, an average of 2 years
description: • The HAQ questions are assessed on a 4-point Likert scale (0 = without difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Total HAQ score ranges from 0-3.0 in increments of 0.125. Higher scores indicate worse functioning.
measure: • Change in Patient reported outcome measure - EuroQoL (EQ-5D)
time frame: through to study completion, an average of 2 years
description: • The EQ-5D consists of 5 domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) rated on a 3 level scale (no problems, some or moderate problems, extreme problems). Rated levels are coded as number 1, 2 or 3 and reported as a five-digit number ranging from 11111 (no problems in all domains) to 55555 (extreme problems in all domains)
measure: • Change in Patient reported outcome measure - Functional Assessment of Chronic Illness Therapy - fatigue (FACIT-fatigue)
time frame: through to study completion, an average of 2 years
description: • FACIT-fatigue is a 13-item instrument measure of fatigue scored on a 0-4 response scale. All items are summed to create a final score (range 0-52). Higher scores indicate greater fatigue.
measure: • Change in Patient reported outcome measure - Hospital Anxiety and Depression Scale (HADs)
time frame: through to study completion, an average of 2 years
description: • HADs consists of two subscales (anxiety and depression) with a total of 14 items - each scored on a scale from 0 to 3. Total scores range from 0-21 for each subscale (0-7 = normal, 9-10 = borderline abnormal, 11-21 = abnormal)
measure: • Change in Patient-completed visual analogue scales - pain (VAS-pain)
time frame: through to study completion, an average of 2 years
description: • VAS-pain measures pain on the day on a visual analogue scale (range 0-100) with higher scores indicating worse pain
measure: • Change in Patient-completed visual analogue scales - disease activity (VAS-DA)
time frame: through to study completion, an average of 2 years
description: • VAS-DA measures the state of arthritis (swelling and stiffness) on the day on a visual analogue scale (range 0-100) with higher scores indicating extremely active arthritis
measure: • Change in Patient-completed visual analogue scales - fatigue (VAS-fatigue)
time frame: through to study completion, an average of 2 years
description: •VAS-fatigue measures overall fatigue on the day on a visual analogue scale (range 0-100) with higher scores indicating worse fatigue
measure: • Change in Patient-completed visual analogue scales - general health (VAS-GH)
time frame: through to study completion, an average of 2 years
description: • VAS-GH measures general state of health on the day on a visual analogue scale (range 0-100) with higher scores indicating poor state of health
measure: • Change in Physician-completed visual analogue scale of disease activity
time frame: through to study completion, an average of 2 years
description: • Physician-completed visual analogue scale of disease activity measures disease activity as rated by the physician on a visual analogue scale (range 0-100) with higher scores indicating extremely active disease
measure: • Change in joint damage as measured by conventional radiography of hands and feet
time frame: through to study completion, an average of 2 years
description: • Change in joint damage as measured by conventional radiography of hands and feet
measure: • Change from baseline in Ultrasound (US) synovitis as measured by Power Doppler Ultrasound (PDUS)
time frame: through to study completion, an average of 2 years
description: • Change from baseline in Ultrasound synovitis as measured by Power Doppler Ultrasound (PDUS)
arm group label: Main Study
description: Participants complete questionnaires and agree to have their retrospective and prospective medical data used as part f this research project. All participants will take part in this arm.
arm group label: Biosample Sub-Study
description: A subset of the participants will take part of this. Participants will agree to have blood samples taken at regular intervals or at the point of a flare or when their treatment changes. They might also be asked to provide urine samples.
arm group label: Synovial Biopsy and Synovial Fluid Sub-Study
description: A subset of the participants will take part of this. Participants will agree to synovial biopsies at regular intervals or at the point of a flare or when their treatment changes. They might also be asked to donate waste synovial fluid.
intervention type: Other
intervention name: No intervention
description: No intervention
arm group label: Biosample Sub-Study
arm group label: Main Study
arm group label: Synovial Biopsy and Synovial Fluid Sub-Study
A maximum of 75mls of blood may be taken to enable the range of experimental studies.

      The blood may be drawn into a combination of EDTA, lithium heparin, red clotted, citrate and
      PAXGENE/TEMPUS tubes, according to planned experiments at each time point. Samples will be
      collected fasting at specific timepoints if indicated.

      Similarly, synovial fluid may also be aspirated from a clinically inflamed joint (usually as
      part of clinical indication), and used for research purpose. Urine samples may also be
      collected (usually as part of clinical indication), and used for research purpose.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Manchester
investigator full name: Prof. Maya H. Buch
investigator title: Clinical Professor of Rheumatology
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
sharing ipd: No