Rheumatoid arthritis prevention with abatacept - long-term outcome study

Plain English summary of protocol

Background and study aims
Rheumatoid arthritis (RA) is an autoimmune, long-term inflammatory disease that causes pain, stiffness, swelling and limited joint movement. RA can affect any joint (most commonly the small joints in the hands and feet) and can develop at any age. The condition can trigger and generate an immune response (e.g. this includes the production of antibodies) that may cause damage to joint tissues and over time may lead to the destruction of cartilage and bone. In some patients, the inflammation can affect other organs such as blood vessels, the eyes or lungs. If not effectively treated, the condition may lead to permanent damage to joints and functional disability in people, including limitations to the quality of life.
RA affects more than 500,000 people in the UK. If not treated effectively, the condition leads to joint damage and significant disability. RA is costly to individuals and their families; one third of patients with arthritis stop work within 2 years of onset because of their disease. RA is costly to the UK economy, estimated to be in the region of £5 billion per year, through direct costs to the NHS and associated healthcare providers, and indirect costs associated with early death and loss of productivity.
Disease-modifying anti-rheumatic drugs (DMARDs) have transformed the treatment of RA. Research has shown that this approach leads to higher proportions of patients becoming symptom-free for long periods. This means they have improved function and joint damage is slowed or even prevented. Intensive treatment of patients with very early RA can mean that some of them can be symptom-free without needing to take medicines. It is important to detect the early signs of RA and to predict which patients are likely to develop severe RA in order to reduce disability and inability to work. People who have mild joint pain can be tested for certain antibodies that are associated with the eventual development of RA.
A previous study called APIPPRA was started in 2013. This study tested whether treatment with a drug called abatacept (Orencia) could prevent the development of RA in people who had joint pain and were positive for the antibodies but did not have the inflammatory signs of RA. Results of this study are expected in early 2021. This study, called ALTO, is following the same participants in APIPPRA on a more long-term basis to investigate whether abatacept treatment prevents or delays additional joints being affected by pain or inflammation.

Who can participate?
Patients enrolled in the APIPPRA study who have completed at least one APIPPRA study visit

What does the study involve?
During the APIPPRA study, participants will have received abatacept or placebo (dummy) injections once weekly for a year and were then followed up without treatment for a further year. In ALTO, they will be assessed every 6 months for a further 3 years.

What are the possible benefits and risks of participating?
ALTO study participants will not receive any study drugs, so there are no risks of side effects as a result of participating. They might benefit from the regular assessment of their condition.

Where is the study run from?
Guy’s and St Thomas’s Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
June 2020 to July 2024

Who is funding the study?
Bristol-Myers Squibb (USA), which sells abatacept

Who is the main contact?
Prof. Andrew Cope (Chief Investigator)
altos@kcl.ac.uk

Contact information

Prof Andrew Cope
Scientific

CIBCI, 1st floor, New Hunt's House
Guy's Campus, Great Maze Pond
London
SE1 1UL
United Kingdom

ORCID ID	0000-0001-6735-5496
Phone	+44 (0)2078480852
Email	altos@kcl.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• Netherlands
• Scotland
• United Kingdom

Study participating centres

Sponsor information

Funders

Funder type

Other

Results and Publications

Study outputs

Editorial Notes

05/12/2024: The overall study end date was changed from 31/07/2023 to 30/07/2024. The intention to publish date was changed from 31/12/2024 to 01/07/2025.
19/03/2024: Total final enrolment added. The intention to publish date was changed from 30/09/2023 to 31/12/2024.
19/10/2022: Ethics approval details added.
20/07/2021: The inclusion criteria and primary and secondary outcomes were updated. The recruitment start date was changed from 01/01/2021 to 26/04/2021.
19/10/2020: The recruitment start date was changed from 01/11/2020 to 01/01/2021.
11/09/2020: The recruitment start date was changed from 01/09/2020 to 01/11/2020 and the contact details were updated.
27/07/2020: The recruitment start date was changed from 01/06/2020 to 01/09/2020.
10/03/2020: This study is a long-term follow-up of participants in the APIPPRA study (ISRCTN46017566).