The ALTO study version 1.0
Research type
Research Study
Full title
ARTHRITIS PREVENTION IN THE PRE-CLINICAL PHASE OF RA WITH ABATACEPT (APIPPRA) LONG TERM OUTCOME STUDY: THE ALTO STUDY
IRAS ID
270373
Contact name
Andrew Cope
Contact email
Sponsor organisation
King's College London
Eudract number
2020-000108-12
ISRCTN Number
ISRCTN12680338
Duration of Study in the UK
2 years, 6 months, 31 days
Research summary
In 2014, the first participant was consented into the Arthritis Prevention in the Preclinical Phase of RA with Abatacept (APIPPRA) clinical trial. This study set out to investigate whether rheumatoid arthritis can be prevented if targeted immunotherapy is given to subjects in whom autoantibody screening, together with symptoms of joint pain (e.g. arthralgia), indicated high risk of developing disease. In this double-blind, placebo controlled, parallel group trial, subjects were randomised to receive weekly subcutaneous injections of the costimulatory blocker CTLA4-Ig (abatacept, OrenciaTM), a biologic drug already licensed for the treatment of established RA, or placebo injections.
After 52 weeks of study drug subjects were monitored for a further 52 weeks. The primary endpoint of the APIPPRA study was the time to development of clinical synovitis or RA.
The purpose of the ALTO study is to capture long term clinical outcomes of all eligible APIPPRA study subjects to establish if abatacept prevents or merely delays the onset of rheumatoid arthritis, and whether treatment of at risk subjects is safe. The study duration is designed in such a way that all those enrolled will have had at least 48 months of treatment and follow up from the start of APIPPRA to the end of the ALTO study.REC name
London - South East Research Ethics Committee
REC reference
21/LO/0035
Date of REC Opinion
5 Mar 2021
REC opinion
Further Information Favourable Opinion