← Back to Search

Immunomodulator

Abatacept for Giant Cell Arteritis

Montréal, Canada
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.

See full description
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 below
Select...
I have been newly diagnosed or have a relapse of Giant Cell Arteritis (GCA).
 show original

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am at risk for tuberculosis.
 show original
Select...
I stopped taking alkylating agents 8 weeks ago.
 show original
Select...
I have had fungal infections that spread throughout my body.
 show original
Select...
My kidneys are not working well, with a creatinine clearance of 20 ml/min or less.
 show original
Select...
I have a history of frequent bacterial infections.
 show original
Select...
I have had cancer in the past 5 years.
 show original
Select...
I recently had an infection.
 show original

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
26%
UPPER RESPIRATORY TRACT INFECTION
21%
NASOPHARYNGITIS
16%
URINARY TRACT INFECTION
11%
GREATER TROCHANTERIC PAIN SYNDROME
11%
RASH
11%
INFLUENZA
11%
CYSTITIS
11%
PNEUMONIA
11%
BLOOD TRIGLYCERIDES INCREASED
5%
EYELID PTOSIS
5%
PERIODONTITIS
5%
SINUSITIS
5%
HEPATIC ENZYME INCREASED
5%
TRIGGER FINGER
5%
ROTATOR CUFF SYNDROME
5%
HYPERCHOLESTEROLAEMIA
5%
BLADDER HYPERTROPHY
5%
DEPRESSION SUICIDAL
5%
SPONDYLOLISTHESIS
5%
ELECTROCARDIOGRAM ABNORMAL
5%
OSTEOMYELITIS
5%
NIGHT SWEATS
5%
TOOTH FRACTURE
5%
UTERINE LEIOMYOMA
5%
RESPIRATORY TRACT INFECTION
5%
TOOTH INFECTION
5%
HIGH DENSITY LIPOPROTEIN DECREASED
5%
ALANINE AMINOTRANSFERASE INCREASED
5%
SKIN PAPILLOMA
5%
ONYCHOMYCOSIS
5%
BURNS SECOND DEGREE
5%
HEADACHE
5%
PYREXIA
5%
POST PROCEDURAL CELLULITIS
5%
FALL
5%
BACK PAIN
5%
OROPHARYNGEAL PAIN
5%
DEPRESSION
5%
URETHRAL STENOSIS
5%
LUNG NEOPLASM MALIGNANT
5%
ASTHMA
5%
DYSPHONIA
5%
CATARACT
5%
ABDOMINAL PAIN
5%
VIRAL UPPER RESPIRATORY TRACT INFECTION
5%
CARPAL TUNNEL SYNDROME
5%
GASTROENTERITIS
5%
OPHTHALMIC HERPES ZOSTER
5%
ASYMPTOMATIC COVID-19
5%
BRONCHITIS
5%
BLOOD CREATININE INCREASED
5%
DYSPEPSIA
5%
LOCALISED INFECTION
5%
OSTEOPOROSIS
5%
COUGH
5%
DIZZINESS
5%
SYNCOPE
5%
PANIC ATTACK
5%
PHARYNGITIS STREPTOCOCCAL
5%
WHITE BLOOD CELLS URINE POSITIVE
5%
WEIGHT INCREASED
5%
MUSCLE SPASMS
5%
SPINAL OSTEOARTHRITIS
5%
ANXIETY
5%
ROSACEA
5%
IRON DEFICIENCY ANAEMIA
5%
ARTHRALGIA
5%
CORNEAL ABRASION
5%
TYPE V HYPERLIPIDAEMIA
5%
MUSCULOSKELETAL CHEST PAIN
100%
80%
60%
40%
20%
0%
Study treatment Arm
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
Period 2, Primary Cohort: Abatacept/Upadacitinib 15 mg QD
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 1, 30 mg Cohort: Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD/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

Closest Location:Cleveland Clinic· Cleveland, OH· 129 miles

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,114 Previous Clinical Trials
45,310,920 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

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
~42 spots leftby Dec 2029
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top