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Contact Information:

Prof Andrew Cope


Study Location:

Royal Surrey County Hospital
Egerton Road
Guildford
GU2 7XX


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Study of patients with early rheumatoid arthritis: The TACERA (Towards a Cure for Early Rheumatoid Arthritis) Study

Medical Conditions

Rheumatoid arthritis


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.




Background and study aims
Patients newly diagnosed with Rheumatoid Arthritis (autoimmune disease that causes inflammation in your joints) are treated conventionally according to National Institute for Health and Clinical Excellence (NICE) guidelines. There is no cure for Rheumatoid arthritis (RA), instead, the goal is to achieve low disease activity and ultimately disease remission. It is not currently possible to predict which drug (or drugs) will produce a favourable response in a particular patient and it is currently difficult to identify patients in clinical remission. This study aims to define predictors of clinical response and define what true remission is in patients with early RA. The plan is to use this information to develop an 'immunological toolkit' to help predict which patients will respond well to particular treatments so that patients can be treated with individualised drug combinations that are most likely to induce and sustain remission.

Who can participate?
The study will recruit 410 participants over the age of 18 within 4 weeks of diagnosis with Rheumatoid Arthritis. They will not have received disease-modifying antirheumatic drugs (DMARDs) or corticosteroid treatment for the current episode of inflammatory arthritis. In addition all subjects will be positive for Rheumatoid Factor and Anti-citrullinated protein antibody (ACPA).

What does the study involve?
Patients will receive standard treatment following national guidelines throughout the study period. The study duration will be 18 months. Patients will be assessed at months 0, 3, 6, 9, 12, 15 and 18 using standard validated questionnaires and blood tests as set out in current guidelines. Biological sampling (blood and urine) will be carried out at each assessment for the purpose of developing an 'immunological toolkit'. X-rays will be taken at 0, 12 and 18 months.

What are the possible benefits and risks of participating?
Although not of direct benefit to participants in the study, it is hoped that the information we get from this study will help improve the treatment of people with rheumatoid arthritis in the future.
As this is an observational study there are no additional risks relating to taking medication involved beyond those which you would experience in routine care. However, there is a modest risk of side effects including pain, bruising, light headedness, and, on rare occasions, infection that could arise as a consequence of having blood taken. To minimise this risk, blood will be taken by a clinical professional trained and experienced in taking blood from patients. In all we will need to take seven lots of blood samples from you, in total about 1.5 - 3 egg cups of blood on each occasion, during this study.

Where is the study run from?
The study is being managed by King's College London. Between 26 and 40 recruitment sites will be set up across England and Scotland.

When is the study starting and how long is it expected to run for?
It is anticipated that recruitment will start Sept/Oct 2012 with the study ending after four years.

Who is funding the study?
The study is funded as part of a programme grant from the Medical Research Council (MRC).

Our working hypothesis is that a suite of immunological assays (hereafter termed 'the immunological toolkit') can be used to accurately predict clinical responses to therapy at a molecular and cellular level. We also propose that immune-based assays can be adapted to define an immune signature associated with a state of sustained clinical remission in patients with early RA. This study protocol seeks to recruit a large cohort of patients with early RA. Biological samples will be acquired from study subjects and used to develop the immunological toolkit, through the identification of baseline biomarker signatures (prior to starting therapy), and by documenting the changes in the immune system in response to therapeutic intervention.

Several principles underpin this study:1. RA is associated with detectable perturbations of the immune system at very early stages of disease. 2. Clinical remission is associated with a biological state that has similarities to a healthy immune system. 3. The healthy immune system is associated with a distinct immunological fingerprint defined by serum, cellular and/or molecular signatures in peripheral blood.4. Restoration of this state of immune health may be induced with therapies that target these perturbations.

More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12364


Longitudinal observational 18-month multicentre study

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

05 Feb 2013

10 Jul 2015

Publications

2020 results in https://doi.org/10.1101/2020.03.08.20028142 (added 07/08/2020)

Observational

Intervention Type : Other
Intervention Description : The study is observational, meaning that we are just looking at how arthritis responds to standard therapy in patients, rather than testing the effects of new treatments. Patients who have been diagnosed with early RA, within 6 months of symptom onset, will receive treatment according to NICE guidelines. Patients will participate in the study for 18 months, attending assessments every 3 months. During these visits a detailed assessment of disease activity (including standard blood monitoring for DMARDs and TNF-inhibitors) will take place along with completion of a number of questionnaires and the provision of additional blood and urine samples for immunoanalysis.

At each study assessment the following will take place:

Patients will complete the following with the research nurse:1. Disease Activity Score (DAS28 & extended swollen and tender joint counts 66/68, patient global assessment)2. HAQ (Health assessment questionnaire measuring disability)3. Lifestyle Factors Questionnaire

The following questionnaires will be completed at Baseline, 6, 12 and 18 months only:1. SF36 (Quality of life questionnaire)2. EQ5D (Health outcome questionnaire)3. FACIT-F questionnaire (Functional assessment of Chronic Illness Therapy)4. IPQ-R-RA (Illness Perception Questionnaire)5. MAPLe-RA (Measuring Actual Patient-Led expectations)

The following will be reviewed:1. Concomitant Diseases and medication2. Current Medication3. Adverse events

The following samples will be taken:1. Blood samples for routine safety monitoring and ESR and CRP values2. Blood and urine samples for the immunoanalysis.

X-rays of hands and feet will be taken at Baseline, 12 and 18 months.

HRUS (High Resolution Ultrasonography) will be undertaken at baseline, 6 and 12 months (an 18 month scan will be optional). This ultasound based imaging is optional and will be offered to patients at those recruiting centres that provide this service as part of routine clinical care.

Patients may also be telephoned by their Research Nurse in between study visits to check how well their disease is being controlled by their medication.


You can take part if:


1. Patients should fulfill either 1987 ACR or 2010 ACR/EULAR classification criteria for diagnosis of early RA2. Positive for serum rheumatoid factor and anti-citrullinated protein autoantibodies (ACPA)3. Within 6 months of symptom onset4. Supervising rheumatologist considers that starting therapy with Disease-modifying antirheumatic drugs (DMARDs) is appropriate5. At least 18 years of age6. Able and willing to give informed consent to provide clinical data and blood samples at defined time points for the duration of the study




You may not be able to take part if:

1. Previous treatment with DMARDs or biologics2. Corticosteroid treatment for the current episode of inflammatory arthritis within the last 6 months (patients with a previous episode of inflammatory arthritis treated with corticosteroids more than 6 months before screening will be permitted providing this episode was not ongoing)3. Use of intramuscular steroid injections between the first clinic attendance (when the diagnosis of RA is made) and study entry4. Significant co-morbidities (e.g. severe congestive heart failure, renal, hepatic, malignant disease), as judged by the supervising physician5. Pregnant or wishing to conceive6. Participating in trials of investigational medicinal products or devices, or other interventions (e.g. exercise) which may have an impact on the patient’s treatment, immune status or disease activity


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Surrey County Hospital
    Egerton Road
    Guildford
    GU2 7XX
  • Royal Free Hospital
    Pond Street
    London
    NW3 2QG
  • Cannock Chase Hospital
    Brunswick Road
    Cannock
    WS11 5XY
  • Freeman Hospital
    Freeman Road
    Newcastle upon Tyne
    NE7 7DN
  • Northwick Park Hospital
    Watford Road
    Harrow
    HA1 3UJ
  • Poole Hospital
    Longfleet Road
    Poole
    BH15 2JB
  • Guy’s Hospital
    Great Maze Pond
    London
    SE1 9RT
  • Manchester Royal Infirmary
    Oxford Rd
    Manchester
    M13 9WL
  • Birmingham City Hospital
    Dudley Road
    Birmingham
    B18 7QH
  • Glasgow Royal Infirmary
    84 Castle Street
    Glasgow
    G4 0SF
  • The James Cook University Hospital
    Marton Road
    Middlesbrough
    TS4 3BW
  • Homerton University Hospital
    Homerton Row
    London
    E9 6SR
  • Croydon University Hospital
    530 London Road
    Croydon
    CR7 7YE
  • Chapel Allerton
    Chapeltown Road
    Leeds
    LS7 4SA
  • University Hospital of North Durham
    Durham North Road
    Durham
    DH1 5TW
  • Darlington Memorial Hospital
    Hollyhurst Rd
    Darlington
    DL3 6HX
  • Doncaster Royal Infirmary
    Armthorpe Rd
    Doncaster
    DN2 5LT
  • The Great Western Hospital
    Marlborough Road
    Swindon
    SN3 6BB
  • Gartnaval General Hospital
    1053 Great Western Road
    Glasgow
    G12 0YN
  • King's College Hospital
    Denmark Hill
    London
    SE5 9RS
  • University Hospital Lewisham
    High Street Lewisham
    London
    SE13 6LH
  • Mile-End Hospital
    Bancroft Road
    London
    E1 4DG
  • Nuffield Orthopedic Hospital
    Windmill Rd
    Oxford
    OX3 7LD
  • University Elizabeth Hospital
    Queen Elizabeth Medical Centre
    Birmingham
    B15 2TH
  • Queen Elizabeth Hospital Gateshead
    Queen Elizabeth Avenue
    Gateshead
    NE9 6SX
  • Queen’s Hospital Burton
    Belvedere Rd
    Burton-on-Trent
    DE13 0RB
  • Queen’s Medical Centre
    Derby Rd
    Nottingham
    NG7 2UH
  • Russells Hall Hospital
    Pensnett Road
    Dudley
    DY1 2HQ
  • Queen Elizabeth Hospital, Woolwich
    Stadium Rd
    London
    SE18 4QH
  • University College London Hospital
    235 Euston Rd Fitzrovia
    London
    NW1 2BU
  • Wishaw General Hospital
    50 Netherton St
    Wishaw
    ML2 0DP

Prof Andrew Cope



The study is sponsored by King's College London (UK); Guy's & St Thomas' Foundation NHS Trust and funded by Medical Research Council [MRC] (UK) ref: 97747; National Institute for Health Research .



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for Trial ID: ISRCTN28793839

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