Rheumatoid Arthritis (RA) is an autoimmune disorder that causes swollen and painful joints, particularly in the hands, feet, wrists and elbows. Other symptoms of RA include inflammation of the lungs and heart, as well as low red blood cell count. The cause of this disorder is not known for certain, but can be a result of differing genetic and environmental factors. RA affects between 0.5 to 1% of adults in the developed world.
Do you suffer from discomfort or pain caused by Rheumatoid Arthritis?
This study is designed to assess efficacy and safety of treatment with an experimental medication for 28 weeks. Participants will receive subcutaneous (SC) injection of one of three different doses of AZD1163 or placebo, along with Standard of Care until Week 24 followed by a safety follow-up (FU) period of 28 weeks.
Would you like to take part?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular study-related follow up on your RA to monitor the effectiveness of the care you’ll receive. The results of this research will be used to determine whether or not the medication being studied will be of benefit to others with early RA. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Have been diagnosed with adult-onset RA as defined by the 2010 ACR/EULAR classification criteria for at least 12 weeks prior to screening.
- Have moderately-to-severely active RA as defined by: a. >= 6 swollen joints on 66SJC and >= 6 tender joints on 68TJC; b. CRP > upper limit of normal.
- Have a positive ACPA at screening.
- Have a history of inadequate response, or loss of response, or intolerance to:
- a. at least one csDMARD treatment, AND/OR
- b. At least one and at most 2 TNFi.
- Have a history of at least 12 weeks treatment and >= 4 weeks stable on a csDMARD and/or SC TNFi prior to the day of randomization.
You may not qualify to participate in this study if you:
- Have a history or evidence of an alternate autoimmune or other condition that could confound the diagnosis of RA. Participants with RA and secondary Sjogren’s disease are eligible.
- Have received or are planning to receive any biologic DMARDs (except for TNFi) or targeted synthetic DMARDs.
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.
