This study is being done in Rheumatoid Arthritis, a long-term disease that causes swelling, pain, and stiffness in the joints. It is comparing baricitinib, a tablet taken by mouth, with two other medicines used for this disease: adalimumab and etanercept, which are given as injections. The purpose of the study is to compare the risk of Venous Thromboembolism, which means a blood clot in a vein, in people treated with these medicines.
In the study, treatment is given over a long period of time, and people are followed while they receive one of the study medicines. The study looks at how often a blood clot in a vein happens after treatment starts. The medicines being studied are baricitinib, adalimumab, and etanercept.
Who Can Join the Study?
Have rheumatoid arthritis and be a patient in the study group.
Have at least one of the following:
Medical records showing a blood clot in a vein before this study. A venous thromboembolism, or VTE, means a blood clot that forms in a vein.
Be 60 years of age or older.
Have a body mass index (BMI, a number based on height and weight) of 30 kg/m² or higher.
Be 50 to less than 60 years old and have a BMI of 25 to less than 30 kg/m².
Have had an inadequate response to at least one disease-modifying antirheumatic drug (DMARD, a medicine that helps control arthritis), or be intolerant to it, meaning the person could not take it because of side effects or other problems.
The DMARD used before may have been a synthetic DMARD, which is a man-made medicine, or a biologic DMARD, which is made from living cells.
Who Cannot Join the Study?
Any reason that makes a person not suitable for taking a TNF inhibitor (a medicine that lowers inflammation by blocking tumor necrosis factor, a body chemical involved in swelling and pain).
Pregnancy or breastfeeding.
Having had more than one VTE (venous thromboembolism, a blood clot in a vein).
Having cancer.
Having active herpes zoster (shingles, a painful rash caused by a virus).
Having a serious infection.
Having active tuberculosis (TB, a serious lung infection).
Having any other serious illness.
Having received a live vaccine within 4 weeks before the study starts. A live vaccine contains a small amount of weakened germ.
Having taken part in any other clinical trial within 4 weeks before the study starts.
Having a history in the past year of IV drug use (drug use by injection into a vein), illicit drug abuse (illegal drug misuse), or chronic alcohol abuse (ongoing heavy alcohol use).
Baricitinib is an oral medicine taken by mouth. In this trial, it is the main study treatment being compared with other arthritis medicines to see how well it works and how safe it is, especially for the risk of blood clots in the veins.
Adalimumab is a medicine given by injection under the skin. It is used as a comparison treatment in the trial so researchers can see how baricitinib compares with a standard TNF inhibitor used for rheumatoid arthritis.
Etanercept is also given by injection under the skin. It is another comparison treatment in the study and helps researchers evaluate baricitinib against commonly used TNF inhibitor treatments for rheumatoid arthritis.
Rheumatoid Arthritis – Rheumatoid arthritis is a long-lasting disease in which the immune system wrongly attacks the lining of the joints. It usually causes joint pain, swelling, stiffness, and reduced movement, often affecting the hands, wrists, and feet. The disease may begin gradually or more suddenly. Over time, it can affect more joints and lead to ongoing joint damage and deformity. Symptoms often come and go in periods of flare and relief.
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