Giant cell arteritis is a disease where blood vessels become inflamed causing symptoms such as headaches, head tenderness, vision difficulties, facial pain, jaw pain, and fever. Local doctors are conducting this clinical research study for people with giant cell arteritis or GCA. This study is testing the safety and effectiveness of an investigational drug for GCA.
Who is eligible to be in this study?
To qualify for this GCA study, you must:
- Have a medical diagnosis of GCA
- Have had signs or symptoms of GCA within past 6 weeks
- Are over 50 years of age
- Meet other specified criteria
What does it cost to be in this study?
It does not cost anything to join the study. All study-related medications and evaluations are provided at no cost and insurance is not required for participation. Qualified participants may also be reimbursed for travel for scheduled office visits.
What are some details of the study?
Study participants will be asked to visit the clinic about 18 times over the span of the first year and about 10 times over the course of the second and third years to undergo medical tests and examinations. These will help monitor safety and measure progress. They could include, but may not be limited to, physical examinations, vital sign measurements (temperature, heart rate, and blood pressure), reviews of your medical history as well as reviews of the current medications you’re taking, and the collection of blood and urine samples. Qualified participants will receive study-related medical care and evaluations at no cost.
What should I know about clinical research studies?
Clinical research studies, also known as medical research studies or clinical trials, are a scientific way to test investigational drugs for the possible future treatment of medical conditions and diseases. Before any treatment or medication is available to the general public, it must be tested in clinical research studies where people volunteer to be study participants. Members of a qualified research team including doctors, nurses, and other healthcare professionals’ first test or screen interested participants to make sure they are able to take part. Following enrollment, study participants receive care from qualified researchers and are monitored for safety during their time in the study.
Studies take place all over the world and can be sponsored by different types of groups such as physicians, medical institutions, foundations, government agencies, and pharmaceutical companies. They can take place in a variety of locations, such as doctors’ offices, hospitals, universities, or community clinics. Studies are conducted in a series of steps called phases. This GCA study is a Phase III study.
How are study participants protected?
Researchers must follow rules to protect the safety of patients who volunteer to take part in clinical research studies. They must follow a detailed plan called a protocol and have the study reviewed by the health authority in which the study is conducted. The study is also reviewed by an independent group called an Institutional Review Board (IRB) or Ethics Committee (EC) who must approve the study before any patients may be enrolled. Site staff must explain the study to potential participants.
Anyone who takes part in a clinical research study has the right to know information about the study such as the reason it is being conducted, potential risks and benefits involved, and expectations of participation. Participation is completely voluntary and a person may decide to withdraw from the study at any time, for any reason.
How is privacy protected?
Clinical research studies are required to follow strict patient privacy guidelines. The names of study participants will not be included with any data about the trial or released to the public. Researchers will maintain strict confidentiality while conducting the study.
Why should I consider participating?
Volunteering for research is not for everyone, but there are reasons it should be considered. It can mean gaining more knowledge of the condition. By participating in this GCA study, it may help develop therapies for the treatment of GCA in the future.
Who should I contact with more questions?
If you have any questions about the investigational treatment or about the study in general, please contact the
study staff in your local area. They will be able to answer your questions.