This phase 3 trial will evaluate the effectiveness of upadacitinib in patients with rheumatoid arthritis. The main outcome to be investigated is a change in disease activity.
The details
Rheumatoid arthritis (RA) is a chronic condition caused by painful swelling and inflammation in the joints. To treat RA, patients are prescribed medications to reduce inflammation. These drugs are called anti-inflammatory disease modifying drugs or DMARDs. Some patients do not respond well to conventional DMARDs.
Upadacitinib is a new experimental drug. It blocks enzymes called Janus kinases that are involved in the production and release of chemicals called cytokines. Cytokines can cause excessive inflammation in diseases like RA. Abatacept is a licensed drug that is commonly prescribed to RA patients. It acts by preventing the activation of immune cells called T cells.
This trial will evaluate the safety and effectiveness of upadacitinib compared to abatacept to treat unresponsive RA patients. Effectiveness will be measured as an improvement in disease activity score (DAS28) after 12 weeks.
Who are they looking for?
This trial will recruit 550 patients with RA. Patients will have been previously treated with at least 1 biological DMARD but still have active RA symptoms. The use of the following synthetic DMARDs is permitted: methotrexate, sulfasalazine, hydroxychloroquine and leflunomide.
Patients that have had previous exposure to other Janus kinase inhibitor drugs and/or abatacept cannot take part in the trial. Patients that have a previous diagnosis of arthritis or an inflammatory joint disease before the age of 17 are also excluded.
How will it work
Patients will be randomly assigned to two groups. One group will receive an intravenous infusion of abatacept at the beginning of the trial and 2, 4, 8, 12, 16 and 20 weeks followed by upadacitinib starting at week 24 up to 5 years. During this time disease activity will be regularly measured. The other group will receive upadacitinib once daily for 24 weeks or up to 5 years.
The main outcome to be investigated is the disease activity score (DAS28). This will involved clinical assessment of 28 joints and measurement of a protein called c-reactive protein from a blood sample.
