Biomarkers of Remission in Rheumatoid Arthritis (BioRRA)

NCT02219347 | Completed

• 1 other identifier: NUTH7100
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; biological markers; remission; ultrasonography; microarray; survival analysis; T cell

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Clinical biomarkers predictive of DMARD-free remission

  At recruitment

• Ultrasound biomarkers of DMARD-free remission

  At recruitment

• Genetic biomarkers of DMARD-free remission

  At recruitment

• Cytokine biomarkers of DMARD-free remission

  At recruitment

• Rheumatoid arthritis disease activity

  At recruitment and at 1 month, 3 months and 6 months following DMARD cessation

Study Arms (1)

DMARD cessation

OTHER

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

Interventions

DMARD cessation DRUG

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

DMARD cessation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: lead
• Newcastle University: collaborator
• Wellcome Trust: collaborator

Study Sites (1)

Newcastle NIHR Clinical Research Facility, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, Tyne & Wear, NE1 4LP, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• John D Isaacs, PhD MBBS

  Newcastle University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: August 18, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)