Rheumatoid Arthritis Clinical Trial
— BioRRAOfficial title:
Biomarkers of Remission in Rheumatoid Arthritis (BioRRA)
Verified date | November 2017 |
Source | Newcastle-upon-Tyne Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Rheumatoid arthritis is a common condition affecting approximately 1% of the United Kingdom
populationÍž it is an autoimmune disease where the body's natural defences (the immune system)
attack the body itself resulting, most notably, in joint damage and arthritis. To help
prevent this, patients with rheumatoid arthritis need to take disease-modifying
anti-rheumatic drugs (DMARDs). As rheumatoid arthritis is a life-long condition, these drug
treatments are prescribed as long-term medications taken for many years.
With successful drug treatment, many patients are able to achieve an excellent control of
their disease and their arthritis can go in to remission. At present, there are no markers
which can reliably predict which of these patients can reduce their drug treatment, and hence
benefit from a lower risk of side effects and inconvenience, without an increase in their
arthritis activity.
We invite patients with stable rheumatoid arthritis to participate in this study conducted by
Newcastle upon Tyne Hospitals NHS Foundation Trust in collaboration with Newcastle University
and funded by the Wellcome Trust. Patients whose arthritis is confirmed as being in remission
will be able to stop their DMARD medication and be monitored for a period of 6 months.
Patients whose arthritis activity increases during this time will be able to restart their
DMARD medication, whereas those patients whose arthritis remains in remission will be able to
stay off DMARD medication.
The main aim of this study is to identify clinical, ultrasound and blood markers that can
predict which patients will remain in remission after stopping DMARD medication. If
identified, these markers could be a useful guide to doctors and patients in the future when
deciding whether to stop DMARD therapy.
Status | Completed |
Enrollment | 74 |
Est. completion date | August 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of rheumatoid arthritis made by consultant rheumatologist at least 12 months previously - Current single or combination use of methotrexate, sulphasalazine and/or hydroxychloroquine - Arthritis currently in remission, as judged clinically by referring healthcare professional - Willing to consider DMARD withdrawal Exclusion Criteria: - Use of biologic therapy within the past 6 months - Received steroids within past 3 months (enteral, parenteral or intra-articular) - Use of any DMARD other than methotrexate, sulphasalazine or hydroxychloroquine within the past 6 months (or past 12 months for leflunomide) - Current pregnancy, or pregnancy planned within next 6 months - Current participation within another clinical trial - Inability to provide informed consent |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Newcastle NIHR Clinical Research Facility, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle upon Tyne | Tyne & Wear |
Lead Sponsor | Collaborator |
---|---|
Newcastle-upon-Tyne Hospitals NHS Trust | Newcastle University, Wellcome Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time-to-flare of arthritis activity following DMARD cessation | Flare of arthritis activity defined as Disease Activity Score in 28 Joints C-Reactive Protein (DAS28-CRP) score greater than or equal to 2.4 | From recruitment, assessed up to 6 months | |
Secondary | Clinical biomarkers predictive of DMARD-free remission | Baseline clinical factors predictive of time-to-flare of arthritis activity following DMARD cessation. | At recruitment | |
Secondary | Ultrasound biomarkers of DMARD-free remission | Baseline musculoskeletal ultrasound biomarkers predictive of time-to-flare of arthritis activity following DMARD cessation, including presence or absence of greyscale synovitis/tenosynovitis and erosions. | At recruitment | |
Secondary | Genetic biomarkers of DMARD-free remission | Baseline signature of differential gene expression in peripheral CD4+ T cells predictive of DMARD-free remission at 6 months following DMARD cessation, as measured using RNA sequencing. | At recruitment | |
Secondary | Cytokine biomarkers of DMARD-free remission | Baseline signature of differential cytokine levels in peripheral blood predictive of time-to-flare of arthritis activity, as measured using a multiplex cytokine assay. | At recruitment | |
Secondary | Rheumatoid arthritis disease activity | Measured by Disease Activity Score in 28 joints (DAS28-CRP) score. | At recruitment and at 1 month, 3 months and 6 months following DMARD cessation | |
Secondary | Physical disability | Measured by Health Assessment Questionnaire Disability Index (HAQ-DI) questionnaire | At baseline and at 6 months following DMARD cessation |
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