Biomarkers of Remission in Rheumatoid Arthritis (BioRRA)
NCT ID: NCT02219347
Last Updated: 2017-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
74 participants
INTERVENTIONAL
2014-08-31
2017-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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DMARD cessation
All patients recruited to the study who have a Disease Activity in 28 Joints C-Reactive Protein (DAS28-CRP) score of \< 2.4 and who do not have power Doppler synovitis on a 7-joint musculoskeletal ultrasound scan will stop their DMARD therapy. These patients will then be followed-up for a period of 6 months or until flare of their arthritis activity, whichever is sooner.
DMARD cessation
Complete cessation of non-biologic DMARD therapy (single or combination of methotrexate, sulphasalazine and/or hydroxychloroquine)
Interventions
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DMARD cessation
Complete cessation of non-biologic DMARD therapy (single or combination of methotrexate, sulphasalazine and/or hydroxychloroquine)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Newcastle University
OTHER
Wellcome Trust
OTHER
Newcastle-upon-Tyne Hospitals NHS Trust
OTHER
Responsible Party
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Principal Investigators
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John D Isaacs, PhD MBBS
Role: PRINCIPAL_INVESTIGATOR
Newcastle University
Locations
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Newcastle NIHR Clinical Research Facility, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne & Wear, United Kingdom
Countries
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Other Identifiers
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NUTH7100
Identifier Type: -
Identifier Source: org_study_id