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Immunomodulator

Abatacept for Giant Cell Arteritis

Phase 3
Recruiting
Led By Jeffrey P Krischer, PhD
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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

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 more

Side effects data

From 2023 Phase 3 trial • 657 Patients • NCT03086343
24%
UPPER RESPIRATORY TRACT INFECTION
24%
HYPERTENSION
18%
BRONCHITIS
12%
ACUTE RESPIRATORY FAILURE
12%
RASH
12%
WEIGHT INCREASED
12%
URINARY TRACT INFECTION
12%
INFLUENZA
12%
FALL
12%
ARTHRALGIA
12%
SINUSITIS
12%
MUSCLE SPASMS
12%
CHOLELITHIASIS
12%
NASOPHARYNGITIS
12%
OROPHARYNGEAL PAIN
12%
LIVER FUNCTION TEST INCREASED
6%
VULVOVAGINAL MYCOTIC INFECTION
6%
LIGAMENT RUPTURE
6%
DEHYDRATION
6%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
6%
NASAL CONGESTION
6%
PULMONARY EMBOLISM
6%
HYPONATRAEMIA
6%
CONSTIPATION
6%
RHINORRHOEA
6%
LEUKOCYTOSIS
6%
BLOOD PRESSURE INCREASED
6%
COUGH
6%
BONE CONTUSION
6%
HIP FRACTURE
6%
VOMITING
6%
PERIPHERAL SWELLING
6%
STAPHYLOCOCCAL INFECTION
6%
ORAL CANDIDIASIS
6%
HERPES ZOSTER
6%
PNEUMONIA
6%
FEELING HOT
6%
HEADACHE
6%
HAEMOGLOBIN DECREASED
6%
PHOTODERMATOSIS
6%
RHEUMATOID ARTHRITIS
6%
PARAESTHESIA
6%
PNEUMONIA BACTERIAL
6%
FEMUR FRACTURE
6%
STOMATITIS
6%
SKIN LACERATION
6%
HYPOKALAEMIA
6%
GLAUCOMA
6%
BACTERIAL SEPSIS
6%
CHEST PAIN
6%
FATIGUE
6%
ATRIOVENTRICULAR BLOCK FIRST DEGREE
6%
CANDIDA INFECTION
6%
TACHYCARDIA
6%
COVID-19
6%
CATARACT
6%
INFECTIOUS PLEURAL EFFUSION
6%
SJOGREN'S SYNDROME
6%
DIZZINESS
6%
DYSPHAGIA
6%
SWELLING
6%
SEBORRHOEIC KERATOSIS
6%
OSTEOARTHRITIS
6%
ACUTE KIDNEY INJURY
6%
NAUSEA
6%
NON-CARDIAC CHEST PAIN
6%
RHINITIS
6%
BLOOD CREATINE PHOSPHOKINASE INCREASED
6%
OSTEOPENIA
6%
INSOMNIA
6%
PRURITUS
6%
SUPRAVENTRICULAR TACHYCARDIA
6%
SCRATCH
6%
EYE HAEMATOMA
6%
ERYTHEMA
6%
COSTOCHONDRITIS
6%
ACTINIC KERATOSIS
6%
DERMATITIS ALLERGIC
6%
ASTHMA
6%
PATELLA FRACTURE
6%
FLANK PAIN
6%
SCIATICA
6%
ANAEMIA
6%
BILIARY COLIC
6%
DERMATITIS CONTACT
6%
HEPATIC STEATOSIS
6%
DRUG HYPERSENSITIVITY
6%
HERPES SIMPLEX
6%
LOCALISED INFECTION
6%
PHARYNGITIS
6%
DIABETES MELLITUS
6%
VITAMIN D DEFICIENCY
6%
BACK PAIN
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/Upadacitinib 15 mg QD
Period 1, 30 mg Cohort: Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/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
2,075 Previous Clinical Trials
42,719,768 Total Patients Enrolled
9 Trials studying Giant Cell Arteritis
4,328 Patients Enrolled for Giant Cell Arteritis
Jeffrey P Krischer, PhDPrincipal InvestigatorUniversity of South Florida
2 Previous Clinical Trials
77 Total Patients Enrolled
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

Media Library

Abatacept (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT04474847 — Phase 3
Giant Cell Arteritis Research Study Groups: Blinded Placebo, Blinded Abatacept
Giant Cell Arteritis Clinical Trial 2023: Abatacept Highlights & Side Effects. Trial Name: NCT04474847 — Phase 3
Abatacept (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04474847 — Phase 3
~28 spots leftby Dec 2026
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