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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: Recruiting Phase 3 study of Giant Cell Arteritis, sponsored by University of Pennsylvania.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Remission is defined as the absence of clinical or imaging features of active disease
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2021-03-29 |
| Est. Completion | 2029-12 |
| Phase | Phase 3 |
What NCT04474847 shows while recruiting
NCT04474847 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 1,039-participant average among 7 other Giant Cell Arteritis trials with a reported enrollment target (92% lower).
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 lists 9 locations in 8 states (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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