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Immunomodulator
Abatacept for Giant Cell Arteritis
Phase 3
Recruiting
Led By Peter A Merkel, MD, MPH
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
Must not have
Patients at risk for tuberculosis
Discontinuation of alkylating agents at least 8 weeks before randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Pivotal Trial
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.
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.
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).
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am at risk for tuberculosis.
Select...
I stopped taking alkylating agents 8 weeks ago.
Select...
I have had fungal infections that spread throughout my body.
Select...
My kidneys are not working well, with a creatinine clearance of 20 ml/min or less.
Select...
I have a history of frequent bacterial infections.
Select...
I have had cancer in the past 5 years.
Select...
I recently had an infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The proportion of participants in remission of those randomized to abatacept as compared to placebo.
Secondary study objectives
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 • 657 Patients • NCT0308634324%
UPPER RESPIRATORY TRACT INFECTION
24%
HYPERTENSION
18%
BRONCHITIS
12%
ACUTE RESPIRATORY FAILURE
12%
RASH
12%
INFLUENZA
12%
ARTHRALGIA
12%
URINARY TRACT INFECTION
12%
WEIGHT INCREASED
12%
FALL
12%
SINUSITIS
12%
MUSCLE SPASMS
12%
CHOLELITHIASIS
12%
NASOPHARYNGITIS
12%
LIVER FUNCTION TEST INCREASED
12%
OROPHARYNGEAL PAIN
6%
SEBORRHOEIC KERATOSIS
6%
HEADACHE
6%
NAUSEA
6%
HIP FRACTURE
6%
PHARYNGITIS
6%
BLOOD CREATINE PHOSPHOKINASE INCREASED
6%
HYPOKALAEMIA
6%
SJOGREN'S SYNDROME
6%
RHINORRHOEA
6%
PNEUMONIA BACTERIAL
6%
ASTHMA
6%
NASAL CONGESTION
6%
PULMONARY EMBOLISM
6%
CONSTIPATION
6%
HYPONATRAEMIA
6%
HEPATIC STEATOSIS
6%
DEHYDRATION
6%
PHOTODERMATOSIS
6%
BLOOD PRESSURE INCREASED
6%
COUGH
6%
BONE CONTUSION
6%
VOMITING
6%
PERIPHERAL SWELLING
6%
STAPHYLOCOCCAL INFECTION
6%
ORAL CANDIDIASIS
6%
HAEMOGLOBIN DECREASED
6%
RHEUMATOID ARTHRITIS
6%
PARAESTHESIA
6%
FEELING HOT
6%
COSTOCHONDRITIS
6%
LEUKOCYTOSIS
6%
TACHYCARDIA
6%
STOMATITIS
6%
PATELLA FRACTURE
6%
ACTINIC KERATOSIS
6%
GLAUCOMA
6%
BACTERIAL SEPSIS
6%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
6%
ATRIOVENTRICULAR BLOCK FIRST DEGREE
6%
CHEST PAIN
6%
FATIGUE
6%
CANDIDA INFECTION
6%
SKIN LACERATION
6%
COVID-19
6%
CATARACT
6%
INFECTIOUS PLEURAL EFFUSION
6%
DYSPHAGIA
6%
SWELLING
6%
ACUTE KIDNEY INJURY
6%
HERPES ZOSTER
6%
PNEUMONIA
6%
OSTEOARTHRITIS
6%
NON-CARDIAC CHEST PAIN
6%
RHINITIS
6%
FEMUR FRACTURE
6%
LIGAMENT RUPTURE
6%
SUPRAVENTRICULAR TACHYCARDIA
6%
SCRATCH
6%
EYE HAEMATOMA
6%
INSOMNIA
6%
ERYTHEMA
6%
PRURITUS
6%
DERMATITIS ALLERGIC
6%
BACK PAIN
6%
DIZZINESS
6%
FLANK PAIN
6%
SCIATICA
6%
ANAEMIA
6%
BILIARY COLIC
6%
DERMATITIS CONTACT
6%
DRUG HYPERSENSITIVITY
6%
HERPES SIMPLEX
6%
LOCALISED INFECTION
6%
VULVOVAGINAL MYCOTIC INFECTION
6%
DIABETES MELLITUS
6%
VITAMIN D DEFICIENCY
6%
OSTEOPENIA
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD
Period 2, Primary Cohort: Upadacitinib 15 mg QD/Upadacitinib 15 mg QD
Period 2, Primary Cohort: Abatacept/Upadacitinib 15 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD
Period 1, 30 mg Cohort: Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
Period 1, Primary and 30 mg Cohorts: Abatacept
Period 1, Primary Cohort: Upadacitinib 15 mg QD
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
~112250
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,084 Previous Clinical Trials
42,726,970 Total Patients Enrolled
9 Trials studying Giant Cell Arteritis
4,328 Patients Enrolled for Giant Cell Arteritis
Peter A Merkel, MD, MPHPrincipal InvestigatorUniversity of Pennsylvania
9 Previous Clinical Trials
2,124 Total Patients Enrolled
3 Trials studying Giant Cell Arteritis
1,492 Patients Enrolled for Giant Cell Arteritis
Jeffrey P Krischer, PhDPrincipal InvestigatorUniversity of South Florida
2 Previous Clinical Trials
77 Total Patients Enrolled
Carol A Langford, MD, MHSPrincipal InvestigatorThe Cleveland Clinic
1 Previous Clinical Trials
65 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.