Abatacept in Individuals Who aRe Considered At Risk of Developing Inflammatory Arthritis — ARCADIA  

Inflammatory Arthritis Clinical Trial

Official title: Phase II Proof of Concept Study of Abatacept (Orencia) in Individuals Who aRe Considered At Risk of Developing Inflammatory Arthritis

Status Recruiting

Clinical Trial Summary

Phase II, single-centre, open label, two parallel arm cohort randomised controlled trial (RCT) testing abatacept in a population of anti-CCP Ab positive individuals at moderate to high risk of developing IA according to a published risk score, already followed in the observational study 'CCP: Next Generation'

Clinical Trial Description

There is now evidence that the immunological disease process starts many years before the onset of clinically detectable inflammatory arthritis (IA). It is now a realistic goal to treat individuals in this pre-clinical phase with the possibility of arresting their progression to clinical disease.

Individuals at risk of developing RA can be identified by the presence of CCP antibodies alongside other clinical features. In Leeds we have developed a prediction model that stratifies these individuals into at-risk vs. low risk. At present there are no treatments in this pathway until individuals develop IA.

T-cells appear to be an appropriate target in at-risk individuals as they play a critical role in the generation and maintenance of autoimmunity. Abatacept (Orencia) is a selective T‑cell modulator that blocks a co-stimulatory signal needed to activate T‑cells and has an excellent safety profile. ;

Related Conditions & MeSH terms

• Arthritis
• Inflammatory Arthritis

• NCT number: NCT04261023
• Study type: Interventional
• Source: University of Leeds
• Contact: Tracy Hulland
• Phone: 011339
• Email: tracy.hulland@nhs.net
• Status: Recruiting
• Phase: Phase 2
• Start date: February 24, 2020
• Completion date: March 31, 2024