Rheumatoid Arthritis Clinical Trial
— RADAROfficial title:
Remote Arthritis Disease Activity MonitoR (RADAR 1) - a Feasibility Study of Home-based Dried Blood Spot Use to Monitor an Inflammatory Marker in Rheumatoid Arthritis Patients.
NCT number | NCT02809547 |
Other study ID # | 16/0019 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | September 2017 |
Verified date | May 2018 |
Source | University of Ulster |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
It is important that patients who suffer from Rheumatoid Arthritis (RA) have their disease monitored at an early stage, as well as when it is established. Presently, if a patient is to be assessed by means of disease activity scores and blood tests, they must attend a hospital appointment, which can be difficult for patients who live far from the clinic. It would be beneficial to be able to monitor and reliably define and report a disease 'flare' at home. Quite often, by the time the patient attends for an appointment, flare ups have subsided. This study will evaluate the possibility for patients to take their own blood samples in the comfort of their own home, by transferring finger prick blood droplets to a dried blood spot sample (DBSS) card. Patients would then send the cards to the laboratory to test for clinically relevant protein markers. The feasibility of 'remote' monitoring of the patient's disease will be explored.
Status | Completed |
Enrollment | 100 |
Est. completion date | September 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: Rheumatoid Arthritis will be diagnosed according to the joint American College of Rheumatology (ACR) and European League against Rheumatism (EULAR) 2010 criteria. Patients who are about to receive their first / a change in combination or dose of DMARD (prospective) or are currently being treated by DMARD therapy will be included in the study. Exclusion Criteria: Patients who have received or are receiving biologic therapy will be excluded from the study. Patients will be representative of the 'real life' patient population in the clinics who meet these criteria, and will not be excluded for other general health reasons. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Northern Ireland Centre for Stratified Medicine/ Altnagelvin Hopsital | Londonderry |
Lead Sponsor | Collaborator |
---|---|
University of Ulster |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | C-Reactive Protein concentrations | Baseline and Six week samples |
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