Biomarkers of Remission in Rheumatoid Arthritis (BioRRA) (BioRRA)
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|ClinicalTrials.gov Identifier: NCT02219347|
Recruitment Status : Completed
First Posted : August 18, 2014
Last Update Posted : November 6, 2017
Rheumatoid arthritis is a common condition affecting approximately 1% of the United Kingdom population; 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.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: DMARD cessation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Biomarkers of Remission in Rheumatoid Arthritis (BioRRA)|
|Actual Study Start Date :||August 2014|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||August 2017|
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.
Drug: DMARD cessation
Complete cessation of non-biologic DMARD therapy (single or combination of methotrexate, sulphasalazine and/or hydroxychloroquine)
- Time-to-flare of arthritis activity following DMARD cessation [ Time Frame: From recruitment, assessed up to 6 months ]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
- Clinical biomarkers predictive of DMARD-free remission [ Time Frame: At recruitment ]Baseline clinical factors predictive of time-to-flare of arthritis activity following DMARD cessation.
- Ultrasound biomarkers of DMARD-free remission [ Time Frame: At recruitment ]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.
- Genetic biomarkers of DMARD-free remission [ Time Frame: At recruitment ]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.
- Cytokine biomarkers of DMARD-free remission [ Time Frame: At recruitment ]Baseline signature of differential cytokine levels in peripheral blood predictive of time-to-flare of arthritis activity, as measured using a multiplex cytokine assay.
- Rheumatoid arthritis disease activity [ Time Frame: At recruitment and at 1 month, 3 months and 6 months following DMARD cessation ]Measured by Disease Activity Score in 28 joints (DAS28-CRP) score.
- Physical disability [ Time Frame: At baseline and at 6 months following DMARD cessation ]Measured by Health Assessment Questionnaire Disability Index (HAQ-DI) questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219347
|Newcastle NIHR Clinical Research Facility, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust|
|Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE1 4LP|
|Principal Investigator:||John D Isaacs, PhD MBBS||Newcastle University|