NCT04261023

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Leeds · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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'

Detailed 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.

Conditions

• Inflammatory Arthritis

Interventions

Type	Name	Description
DRUG	Orencia 125 MG Per 1 ML Prefilled Syringe	Abatacept sub-cutaneous injection 125mg at week 0 and once weekly thereafter for a maximum of 48 weeks

Timeline

• Start date: 2020-02-24
• Primary completion: 2021-03-15
• Completion: 2021-03-15
• First posted: 2020-02-07
• Last updated: 2025-03-30

Locations

1 site across 1 country: United Kingdom