Arthritis, Rheumatoid Clinical Trial
Official title:
Inhibition of Co-Stimulation in Rheumatoid Arthritis
The purpose of this study is to use abatacept as a clinical molecular probe to evaluate the effects of inhibiting costimulation on immune responses in patients with rheumatoid arthritis (RA).
Rheumatoid arthritis (RA) is a chronic inflammatory immune mediated arthritis which leads to
pain, swelling and destruction of joints. RA affects more than 500,000 subjects in the
United Kingdom (UK) and incurs significant health and economic cost. Most patients require
potent immune suppressing drugs such as methotrexate, which help reduce pain and stiffness,
and protect the joints against damage. However, many patients do not respond or are unable
to tolerate methotrexate. In these patients, biologic drugs such as abatacept are used to
try to control the arthritis.
Abatacept is designed to target and inhibit a specific molecule involved in "costimulation"
of the inflammatory signal that is thought to be important in RA. While abatacept has been
shown to be effective in trials and clinical practice, the exact mechanism of action of
abatacept in RA has not been fully elucidated. Understanding these actions is likely to
inform both the use of abatacept in RA and lead to increased understanding of inflammation
in humans with implications for further therapies. This six month prospective open label
study, therefore, aims to investigate the effects of inhibiting costimulation on a variety
of important inflammatory cell types and processes in humans with RA.
25 participants with RA who have bad prognostic genetic markers (Anti-citrullinated protein
antibodies (ACPA) and human leukocyte antigen (HLADR4) and who were scheduled to receive
subcutaneous abatacept as part of their standard clinical treatment will be recruited.
Consenting participants will followed for a total of 24 weeks during which time they will
have additional venous blood and urine samples taken to investigate the effects of abatacept
on their immune cells and system. The primary endpoint of the study is the characterisation
of the immune response following costimulatory modulation in RA patients at 12 weeks.
Secondary endpoints include change in immunological response and its association with
clinical outcome measures up to 24 weeks.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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