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Immunomodulator
Abatacept for Giant Cell Arteritis
Phase 3
Waitlist Available
Led By Carol A Langford, MD, MHS
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A diagnosis of newly diagnosed or relapsing GCA. Diagnostic criteria for GCA
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial will compare abatacept to placebo in GCA patients to see if it is effective in achieving remission. If patients don't achieve remission, they may have the option of receiving abatacept for up to 12 months.
Who is the study for?
This trial is for adults with newly diagnosed or relapsing Giant Cell Arteritis (GCA) who meet specific diagnostic criteria. Participants must be able to follow the study plan and use effective birth control. Those with severe diseases, recent infections, certain drug treatments, kidney issues, blood disorders, cancer history within 5 years, or allergy to abatacept can't join.Check my eligibility
What is being tested?
The trial tests if Abatacept is better than a placebo in treating GCA. Patients are randomly assigned to get either Abatacept or a placebo once a week for up to 12 months. If they don't improve by Month 3 or have a relapse within the first year, they may receive open-label Abatacept.See study design
What are the potential side effects?
Abatacept may cause side effects like infection risk increase due to immune system suppression, infusion reactions similar to allergic responses during treatment administration, and potential worsening of underlying conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been newly diagnosed or have a relapse of Giant Cell Arteritis (GCA).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The proportion of participants in remission of those randomized to abatacept as compared to placebo.
Secondary outcome measures
Duration of glucocorticoid-free remission from Month 6 to Month 12
Health-related quality of life in those treated with abatacept versus placebo: PROMIS questionnaire
Health-related quality of life in those treated with abatacept versus placebo: SF-36
+1 moreSide effects data
From 2023 Phase 3 trial • 613 Patients • NCT030863436%
URINARY TRACT INFECTION
5%
UPPER RESPIRATORY TRACT INFECTION
5%
NASOPHARYNGITIS
3%
HYPERTENSION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abatacept
Upadacitinib 15 mg
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Blinded AbataceptExperimental Treatment1 Intervention
Participants will receive blinded abatacept 125 mg administered by subcutaneous injection once a week for at least 12 months. Subjects may be removed from treatment earlier due to a disease relapse, disease worsening, or if they have not achieved remission.
Group II: Blinded PlaceboPlacebo Group1 Intervention
Participants will receive blinded placebo. Placebo will be administered by subcutaneous injection once a week for at least 12 months. Subjects may be removed from treatment earlier due to a disease relapse, disease worsening, or if they have not achieved remission.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abatacept
2005
Completed Phase 4
~112150
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,010 Total Patients Enrolled
9 Trials studying Giant Cell Arteritis
4,328 Patients Enrolled for Giant Cell Arteritis
Carol A Langford, MD, MHSPrincipal InvestigatorThe Cleveland Clinic
1 Previous Clinical Trials
65 Total Patients Enrolled
Jeffrey P Krischer, PhDPrincipal InvestigatorUniversity of South Florida
2 Previous Clinical Trials
77 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken certain medications recently.I have not received a live vaccine in the last 3 months.I have stopped taking non-biologic immunosuppressants.I need oral or IV steroids for a condition that's not giant cell arteritis.I am willing to use effective birth control.I have a diagnosed disease.You are allergic to abatacept or any of its ingredients.I am at risk for tuberculosis.Your blood tests show very low levels of platelets, white blood cells, or neutrophils, or very low hematocrit levels.My giant cell arteritis has been active in the last 8 weeks.My condition is stable enough not to interfere with the study.I stopped taking alkylating agents 8 weeks ago.I have been newly diagnosed or have a relapse of Giant Cell Arteritis (GCA).I have had fungal infections that spread throughout my body.My kidneys are not working well, with a creatinine clearance of 20 ml/min or less.I have a history of frequent bacterial infections.You have a history of a weak immune system from birth.You have at least 3 out of 5 specific symptoms that show you have giant cell arteritis.You have had repeated cases of shingles or widespread herpes.I have had cancer in the past 5 years.I recently had an infection.Your liver enzymes (AST or ALT) are more than three times the normal range.
Research Study Groups:
This trial has the following groups:- Group 1: Blinded Placebo
- Group 2: Blinded Abatacept
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any participating sites in the United States or Canada?
"So far, six different hospitals have patients enrolled in this trial. They are Hospital for Special Surgery in New york, St. Joseph's Healthcare in Hamilton, University of Pennsylvania in Philadelphia, and three other locations."
Answered by AI
Does the FDA recognize Abatacept as a legitimate medication?
"Abatacept is considered safe, as it has progressed to Phase 3 clinical trials. This means that there is supporting data for its efficacy, and multiple rounds of safety testing have been completed."
Answered by AI
Could you give some more information about other research done on Abatacept?
"University of Nebraska Medical Center first studied abatacept in 2007 and, since then, 18353 similar studies have completed. As of now, there are 36 ongoing trials related to abatacept; many of these taking place in New york City."
Answered by AI
What medical conditions does Abatacept typically treat?
"Abatacept is a medication used to treat various autoimmune diseases, the most common being rheumatoid arthritis. However, abatacept has also shown efficacy in treating psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and severe juvenile idiopathic arthritis."
Answered by AI
How many individuals are seeking to take part in this clinical trial?
"Unfortunately, this particular clinical trial is no longer actively enrolling patients. The study was originally posted on March 15th, 2021 and last updated on October 12th, 2022. However, there are 37 other trials for cranial arteritis and 36 studies for Abatacept that are still looking for participants."
Answered by AI
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