Biomarkers of Remission in Rheumatoid Arthritis (BioRRA)

Rheumatoid Arthritis Clinical Trial

— BioRRA  

Official title:

Biomarkers of Remission in Rheumatoid Arthritis (BioRRA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02219347
• Other study ID #: NUTH7100
• Status: Completed
• Phase: N/A
• First received: August 15, 2014
• Last updated: November 1, 2017
• Start date: August 2014
• Est. completion date: August 2017

Study information

• Verified date: November 2017
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• DMARD cessation
Complete cessation of non-biologic DMARD therapy (single or combination of methotrexate, sulphasalazine and/or hydroxychloroquine)

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust	Newcastle University, Wellcome Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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