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NCT04474847 · ClinicalTrials.gov registry record · Phase 3

Abatacept for the Treatment of Giant Cell Arteritis

A Phase 3 study of Giant Cell Arteritis, sponsored by University of Pennsylvania.

Recruiting
Registry status
Phase 3
Development phase
78
Enrollment target
9
Study locations

NCT04474847 is a Phase 3 study of Giant Cell Arteritis that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 78 participants, below the 1,039-participant average among 7 other Giant Cell Arteritis trials with a reported enrollment target (92% lower). The trial reports 9 study locations across 8 states.

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The verdict

NCT04474847, a Phase 3 study of Giant Cell Arteritis, is actively recruiting participants, sponsored by University of Pennsylvania.

RECRUITING
Registry status
Phase 3
Development phase
78 participants
Enrollment target
9
Study locations

Study Summary

This randomized, double-blind, placebo-controlled trial will seek to determine the efficacy of abatacept in GCA. To examine this objective, 62 eligible patients who have newly diagnosed or relapsing GCA within 8 weeks prior to screening will be randomized at a 1:1 ratio to receive subcutaneous abatacept 125mg/week or placebo. Patients who achieve remission will remain on their blinded assignment for 12 months at which time abatacept/placebo will be stopped. Patients who do not achieve remission by Month 3, who experience a relapse within the first 12 months will have the option of receiving open-label abatacept for a maximum of 12 months.

Conditions Studied

Giant Cell Arteritis

Interventions

  • DRUG Placebo
  • DRUG Abatacept

Study Locations (9)

Ontario

  • St. Joseph's Healthcare - Hamilton
  • Mount Sinai Hospital - Toronto

Minnesota

  • Mayo Clinic - Rochester

New York

  • Hospital for Special Surgery - New York

Ohio

  • Cleveland Clinic - Cleveland

Pennsylvania

  • University of Pennsylvania - Philadelphia

Tennessee

  • Vanderbilt University - Nashville

British Columbia

  • University of British Columbia - Vancouver

Quebec

  • Hôpital du Sacré-Coeur de Montréal Université de Montréal - Montreal

Trial Details

FieldValue
Enrollment Target 78 participants
Start Date 2021-03-29
Est. Completion 2029-12
Phase Phase 3

Sponsor

University of Pennsylvania

1,423 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04474847

The ClinicalTrials.gov registry entry for NCT04474847 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,039-participant average among 7 other Giant Cell Arteritis trials with a reported enrollment target (92% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Giant Cell Arteritis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04474847 reports 9 study locations spanning 8 distinct geographic areas - top geographies include Ontario, Minnesota, New York.

Frequently Asked Questions

What is clinical trial NCT04474847 about?

NCT04474847 is a clinical study titled "Abatacept for the Treatment of Giant Cell Arteritis". This randomized, double-blind, placebo-controlled trial will seek to determine the efficacy of abatacept in GCA. To examine this objective, 62 eligible patients who have newly diagnosed or relapsing GCA within 8 weeks prior to screening will be randomized at a 1:1 ratio to receive subcutaneous abata...

What is the current status of trial NCT04474847?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 78 participants. The study started on 2021-03-29. Estimated completion is 2029-12.

What conditions does trial NCT04474847 study?

This clinical trial studies the following conditions: Giant Cell Arteritis.

What interventions are being tested in trial NCT04474847?

The interventions under investigation include: Placebo (DRUG), Abatacept (DRUG).

Who is sponsoring clinical trial NCT04474847?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04474847 being conducted?

This trial has 9 study locations across Minnesota, New York, Ohio, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.