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  • Writer's picturePMO team

4 clinical trials included in RTCure

Updated: May 30, 2018

In RTCure we aim to design efficient but informative experimental medicine studies of potentially tolerogenic therapies. Already from the beginning of the project we have four clinical trials that are associated with the RTCure project so that the results from these studies can help us designing new studies, and inform us on biomarker strategies to apply in other RTCure trials.

The first trial, the ASCARA study, has already been presented to you in our previous post. As you already know, the aim of this study is to investigate if abatacept can reverse the activated, proliferative phenotype of ACPA-expressing B-cells. In the following paragraphs, we will provide you detailed insights into the 3 other clinical trials.

Trial 1: ICoSRA

The ICoSRA (full title: Inhibition of Co-Stimulation in Rheumatoid Arthritis) trial is being conducted by the University of Glasgow (UGLA), and funded by Bristol-Myers Squibb (BMS). The trial aims to characterise the changes in immunological function in response to a co-stimulatory blockade with abatacept in RA patients with the HLA-DR genotype HLA-DRB1*0401 or *0404.

Abatacept is designed to target and inhibit a specific molecule involved in the co-stimulation 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 lead to an 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 co-stimulation on a variety of important inflammatory cell types and processes in humans with RA.

25 participants with RA who have prognostic genetic markers (anti-citrullinated protein antibodies (ACPA) and human leukocyte antigen (HLA-DR4)) and who were scheduled to receive subcutaneous abatacept as part of their standard clinical treatment will be recruited. Consenting participants will be followed for a total of 24 weeks during which 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 co-stimulatory modulation in RA patients at 12 weeks. Secondary endpoints will include change in immunological response and its association with clinical outcome measures up to 24 weeks.

Understanding the effects of co-stimulatory blockade on immune responses in RA patients who are HLADRB1* 0401/0404 positive will greatly advance our understanding of the underlying pathophysiology of this disease. The principal objective of this study is to characterise the effects of co-stimulatory modulation with abatacept on important immune (T, B and DC) cells in patients with RA. Specifically, this study will test the hypothesis that co-stimulatory blockade with abatacept will lead to changes in the behaviour of antigen-specific T-cells that in turn are implicated in RA pathogenesis. This will inform potential tolerising approaches with abatacept alone or in combination with other approaches in pre-rheumatoid arthritis or early rheumatoid arthritis.

Follow this link for more information.

Trial 2: ARIAA

The ARIAA (full title: Abatacept Reversing subclinical Inflammation as measured by MRI in anti-citrullinated protein antibodies positive Arthralgia) trial is a randomised double-blind, placebo-controlled, multi-centre study in patients with ACPA positive arthralgia coordinated by Universitatsklinikum Erlangen (UKER), and funded by Bristol-Myers Squibb (BMS). The primary outcome is the proportion of patients with an improvement of acute inflammation characterised as improvement of synovitis (synovialitis or tenosynovitis) or osteitis in the MRI of the dominant hand after 6 months of treatment with abatacept or placebo.

​Follow this link for more information.

Trial 3: APIPPRA

APIPPRA (full title: Arthritis Prevention In the Pre-clinical Phase of Rheumatoid Arthritis with Abatacept) is a study by King's College London (KCL), specifically focused on preventing progression to rheumatoid arthritis.

The purpose of this study is to determine whether rheumatoid arthritis (RA) can be prevented if therapy is given to individuals at high risk of developing the disease, as defined by the presence of auto-antibodies in the blood, together with joint symptoms (pain but not joint swelling). In a controlled clinical trial setting, the feasibility, acceptability and effectiveness of a 12 month course of therapy with a drug called abatacept will be investigated in subjects at high risk of developing RA. This drug has been chosen because it has beneficial effects in established RA, a good safety profile, and because of its beneficial effects on reducing harmful immune responses. At the same time we plan to investigate immune and inflammatory responses before, during and after therapy with abatacept in order to better understand the immune system at the very earliest detectable stages of disease.

​Follow this link for more information.

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