Clinical trial NCT02219347: Biomarkers of Remission in Rheumatoid Arthritis (BioRRA)
Official title: Biomarkers of Remission in Rheumatoid Arthritis (BioRRA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
biological markers
remission
ultrasonography
microarray
survival analysis
T cell
Lead sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Newcastle University
name: Wellcome Trust
First posted: 2014-08-18
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time-to-flare of arthritis activity following DMARD cessation
timeFrame: From recruitment, assessed up to 6 months
Secondary outcomes:
measure: Clinical biomarkers predictive of DMARD-free remission
timeFrame: At recruitment
measure: Ultrasound biomarkers of DMARD-free remission
timeFrame: At recruitment
measure: Genetic biomarkers of DMARD-free remission
timeFrame: At recruitment
measure: Cytokine biomarkers of DMARD-free remission
timeFrame: At recruitment
measure: Rheumatoid arthritis disease activity
timeFrame: At recruitment and at 1 month, 3 months and 6 months following DMARD cessation
measure: Physical disability
timeFrame: At baseline and at 6 months following DMARD cessation
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Newcastle NIHR Clinical Research Facility, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust
state: Tyne & Wear
Study officials:
affiliation: Newcastle University
name: John D Isaacs, PhD MBBS
role: PRINCIPAL_INVESTIGATOR
References: