RADAR1- Trial of a New Blood Sample Method (Remote Arthritis Disease Activity MonitoR)

NCT02809547 | Completed

• 1 other identifier: 16/0019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• C-Reactive Protein concentrations

  Baseline and Six week samples

Study Arms (2)

In Clinic monitoring

ACTIVE COMPARATOR

70 method comparison patients who represent a C-reactive protein (CRP) reference range and have retrievable study outcome measures will have a whole blood sample and DBSS taken at recruitment and at a routine six week review.

Device: Dried Blood Spot device

At Home monitoring

EXPERIMENTAL

30 Prospective patients will provide (i) one whole blood sample and one set of dried blood spot samples (DBSS) at recruitment, (ii) a set of DBSS once a week for six weeks from recruitment, with a matched whole blood sample at six week appointment, (iii) two extra sets of DBSS to be taken during a flare and 24 hours after (iv) 6 prospective patients will have daily hand movement data collected for 5 minutes on each occasion using a provided data glove.

Device: Dried Blood Spot device

Interventions

Dried Blood Spot device DEVICE

At Home monitoring; In Clinic monitoring

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ulster: lead

Study Sites (1)

Northern Ireland Centre for Stratified Medicine/ Altnagelvin Hopsital

Londonderry, BT47 6SB, United Kingdom

Location

Related Publications (1)

• D'Cruz LG, McEleney KG, Cochrane C, Tan KBC, Shukla P, Gardiner PV, Small D, Zhang SD, Gibson DS. Assessment of a dried blood spot C-reactive protein method to identify disease flares in rheumatoid arthritis patients. Sci Rep. 2020 Dec 3;10(1):21089. doi: 10.1038/s41598-020-77826-0.

  PMID: 33273485 DERIVED

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: June 22, 2016
• Study Start: November 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: September 1, 2017
• Last Updated: May 8, 2018

Record last verified: 2018-05

Locations

GB (1)