Giant Cell Arteritis
Giant Cell Arteritis Novartis Research Study
If you have giant cell arteritis (GCA), then you are familiar with severe headaches, tender scalp, jaw pain, fever, fatigue, unintended weight loss, and, in some cases, the vision problems that accompany it.
Even though there is no cure, scientists are researching if secukinumab may be able to treat giant cell arteritis. You may be able to help them on their mission of finding innovative treatments to relieve the symptoms that accompany GCA.
ABOUT THE DRUG
What Is Secukinumab?
The FDA approved the study drug secukinumab to treat several rheumatic diseases, including psoriatic arthritis, severe to moderate plaque psoriasis, and ankylosing spondylitis.
The protein IL-17A is associated with the pain, inflammation, and damage caused by various rheumatic diseases. Secukinumab blocks the action of IL-17A to reduce inflammation and pain.
ABOUT THE DRUG
What Is Secukinumab?
The FDA approved the study drug secukinumab to treat several rheumatic diseases, including psoriatic arthritis, severe to moderate plaque psoriasis, and ankylosing spondylitis.
The protein IL-17A is associated with the pain, inflammation, and damage caused by various rheumatic diseases. Secukinumab blocks the action of IL-17A to reduce inflammation and pain.
Frequently Asked Questions
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How long does the study last?
The Giant Cell Arteritis Novartis Research Study lasts 104 weeks (2 years). If qualified, there are required visits at our clinic in The Woodlands at weeks 0, 1, 2, 3, and 4. Afterward, visits are 4 weeks apart.
How is the study conducted?
Researchers will divide participants into two groups. One group will receive the secukinumab treatment, while the other group will receive a placebo. All participants will continue to receive corticosteroids. After 56 weeks, the placebo group will have the opportunity to receive secukinumab. Secukinumab is given as a subcutaneous treatment, and all participants in the study are required to be receiving corticosteroid therapy.
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What happens during each visit?
During visits, participants will fill out questionnaires, have an exam, and have blood samples drawn. A bone density test will occur during three visits, and some participants will be selected for head MRA’s.
What is the purpose of this study?
Secukinumab already has FDA approval to treat various rheumatic conditions. This study provides the opportunity to collect data to see if the drug is effective in treating GCA, the best dosage level and if there are any adverse effects.
Data collected will then be presented to the FDA to gain approval to market secukinumab as a treatment for GCA.
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Qualification Requirements
If you have been diagnosed with Giant Cell Arthritis you may be a candidate for participation in a new clinical trial using an alternative treatment. Those with a history of certain other serious conditions or infections may not qualify to take part.
To qualify, you must:
- Be age 50 and older
- Diagnosed with GCA within the last six weeks or relapsing GSA (diagnosed more than six weeks ago and symptoms returned after a relapse).
There are no out-of-pocket costs to the participant. However, any eligible subjects will be required to undergo a TB screening, chest x-ray, and ECG and provide a complete medical history to researchers.
Pregnant and nursing women are not eligible. People with uncontrolled conditions or certain infections are not eligible.
Learn If You Qualify
If you are interested in the study, fill out the form below or call us at (281) 884-9844.