Trial intelligence / Profile preview

Abatacept in at-risk inflammatory arthritis

NCT04261023Phase 2

Key facts

Status: Terminated
Start: Feb 2020
Primary completion: Mar 2021
Countries: 1
Sponsor: University of Leeds
Modality: Fc-Fusion Proteins

Drugs: abatacept
Conditions: inflammatory arthritis

Overview

Phase 2, randomised, open-label trial of abatacept in inflammatory arthritis (2 arms), sponsored by University of Leeds. Primary endpoint: Individuals who develop inflammatory arthritis at 48 weeks. Started Feb 2020; status: terminated.

Design

2 arms

Study design: RandomizedOpen-label

Abatacept
Abatacept 125mg SC weekly for 48 weeks
Control
Usual care (CCP Next Generation observational cohort)

Who it enrols

Adults participating in the CCP 'Next Generation' cohort who are anti-CCP positive and at moderate to high risk of developing inflammatory arthritis.

Endpoints

Primary

Individuals who develop inflammatory arthritis48 weeks

Secondary

Acute phase reactant levels96 weeks
Ultrasound synovitis and erosions96 weeks
Plain radiograph96 weeks
Patient-reported measures96 weeks
Joint swelling and tenderness96 weeks
T-cell subset levels96 weeks
Toxicity levels96 weeks

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