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Immunomodulator

Abatacept for Wegener's Granulomatosis

Phase 3

Waitlist Available

Led By Carol A Langford, MD, MHS

Research Sponsored by University of South Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is looking at whether abatacept can help people with GPA achieve remission without the use of glucocorticoids. People will be given either abatacept or a placebo once a week for at least 12 months. If they don't achieve remission or have a disease flare-up, they may be given abatacept in an open-label trial period.

Eligible Conditions

Wegener's Granulomatosis
Vasculitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Ability of abatacept to reduce the treatment failure rate

Secondary outcome measures

Duration of glucocorticoid-free periods

Health-related quality of life in those treated with abatacept versus placebo

Prevention of disease- or treatment-related damage with abatacept versus placebo

+2 more

Side effects data

From 2023 Phase 3 trial • 613 Patients • NCT03086343

URINARY TRACT INFECTION

UPPER RESPIRATORY TRACT INFECTION

NASOPHARYNGITIS

HYPERTENSION

100%

80%

60%

40%

20%

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 by treatment month 6.

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 by treatment month 6.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abatacept

2005

Completed Phase 4

~112150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of PennsylvaniaOTHER

2,002 Previous Clinical Trials

42,880,934 Total Patients Enrolled

The Cleveland ClinicOTHER

1,027 Previous Clinical Trials

1,364,213 Total Patients Enrolled

University of South FloridaLead Sponsor

410 Previous Clinical Trials

186,843 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Abatacept is most often given to patients for what purpose?

"Abatacept is frequently administered to patients with rheumatoid arthritis. However, it can also help those struggling with conditions such as psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and severe juvenile idiopathic arthritis."

Answered by AI

Abatacept has been studied pretty extensively, right? So it must be safe for human consumption?

"Abatacept Phase 3 clinical trial data suggests that the medication is safe and effective, so it received a score of 3."

Answered by AI

Could you inform me as to how many different clinics are participating in this study?

"In addition to the 15 sites previously mentioned, this trial is also accepting patients from University of Utah, Cedars Sinai Medical Center, and Oregon Health & Science University."

Answered by AI

To what extent has Abatacept been studied in the medical community?

"Abatacept was first trialled in 2007 by University of Nebraska Medical Center. So far, there have been 2777 completed trials and 36 more are ongoing. The majority of these live clinical trials are based in Salt Lake City, Utah."

Answered by AI