Observational Chart Review of Patients with Rheumatoid Arthritis
Research type
Research Study
Full title
Observational Chart Review of Patients with Rheumatoid Arthritis Treated with Abatacept
IRAS ID
242712
Contact name
Ernest Choy
Contact email
Sponsor organisation
Bristol-Myers Squibb Pharmaceuticals Ltd.
Duration of Study in the UK
0 years, 9 months, 19 days
Research summary
Rheumatoid arthritis (RA) is an inflammatory autoimmune disease that causes progressive joint destruction and consequential functional disability and affects over 400,000 people in the UK.
Historically, RA has been labelled as seropositive or seronegative, according to the presence or absence of detectable rheumatoid factor (RF). Recently, a large portion of patients with RA were shown to produce antibodies recognising certain peptides containing citrullinated arginine residues, summarised as anti-citrullinated peptide/protein antibodies (ACPA). The value of RF and ACPA for diagnostic/prognostic purposes has been well established but their role and associations with disease activity, for example Disease Activity Score for 28 joints (DAS28)), is less clear.
Abatacept is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who responded inadequately to previous therapy. While the value of abatacept in the RA has been demonstrated in the broader population, the value of abatacept in defined patient subgroups (based on RF and ACPA antibody status) may differ.
This study is designed to generate real-world evidence describing the treatment experience and outcomes of RA patients with a treatment history of abatacept, emphasising comparisons between patients with differing antibody statuses.
The study will take place in 4 hospital sites in Wales and England. Clinical data will be sourced directly from the medical records of patients that have received treatment with abatacept for the treatment of RA at any line of therapy (LOT) between 01 January 2013 – 31 December 2017.
Data collection will be entirely retrospective and does not involve direct patient contact. To ensure patient confidentiality, all data will be anonymised during data collection and before data delivery to the CRO. The sponsor and CRO will only receive anonymised data and will not have access to patient identifiable information.
The study is sponsored by Bristol-Myers Squibb Pharmaceuticals Ltd.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
18/YH/0412
Date of REC Opinion
15 Oct 2018
REC opinion
Favourable Opinion