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NCT00556439 · ClinicalTrials.gov registry record · Phase 2
Abatacept for Treating Adults With Giant Cell Arteritis and Takayasu's Arteritis
A Phase 2 study of Giant Cell Arteritis and Takayasu's Arteritis, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- Completed
- Registry status
- Phase 2
- Development phase
- 97
- Enrollment target
- 10
- Study locations
NCT00556439: Completed Phase 2 study of Giant Cell Arteritis and Takayasu's Arteritis, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
NCT00556439 is a Phase 2 study of Giant Cell Arteritis and Takayasu's Arteritis that has completed, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 97 participants, below the 1,036-participant average among 7 other Giant Cell Arteritis trials with a reported enrollment target (91% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00556439, a Phase 2 study of Giant Cell Arteritis and Takayasu's Arteritis, has completed, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 97 participants
- Enrollment target
- 10
- Study locations
Study Summary
Giant cell arteritis (GCA) and Takayasu's arteritis (TAK) are diseases that cause swelling of the arteries in the head, neck, upper body, and arms. TAK specifically affects the aorta, the largest blood vessel in the body, and its branches. Therapies are available to improve the symptoms of GCA and TAK, but relapse often occurs, and better treatments are needed. Abatacept is a drug that interacts with certain cells in the body that are involved with GCA and TAK. This study will evaluate the effectiveness of abatacept in treating GCA and TAK and preventing disease relapse.
Primary Outcome
Relapse: presence of active disease occurring after a period of remission Remission: absence of active disease Active disease defined by clinical features or imaging or both: Clinical features: 1 or more of the following attributed to GCA/TAK: * Sustained fever of \>38 C for \> 1 week * Vascular pain/tenderness \> 1 day, non-fleeting * Headache a) present \> 1 day b) non-fleeting c) not relieved with analgesics d) not typical for pre-existing headaches * Ischemic retinopathy, optic neuropat
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Abatacept
Study Locations (10)
Ontario
- St. Joseph's Hospital - Hamilton
- Mt. Sinai Hospital Toronto - Toronto
California
- Cedars-Sinai Medical Center - Los Angeles
Maryland
- Johns Hopkins Medical Center - Baltimore
Massachusetts
- Boston University - Boston
Minnesota
- Mayo Clinic - Rochester
New York
- Hospital for Special Surgery - New York
Ohio
- Cleveland Clinic - Cleveland
Pennsylvania
- University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2008-12 |
| Est. Completion | 2015-08 |
| Phase | Phase 2 |
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)93 total trials
What the finished NCT00556439 record still lists
NCT00556439 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 1,036-participant average among 7 other Giant Cell Arteritis trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Giant Cell Arteritis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00556439 lists 10 locations in 9 states (Ontario, California, Maryland).
Frequently Asked Questions
What is clinical trial NCT00556439 about?
NCT00556439 is a clinical study titled "Abatacept for Treating Adults With Giant Cell Arteritis and Takayasu's Arteritis". Giant cell arteritis (GCA) and Takayasu's arteritis (TAK) are diseases that cause swelling of the arteries in the head, neck, upper body, and arms. TAK specifically affects the aorta, the largest blood vessel in the body, and its branches. Therapies are available to improve the symptoms of GCA and T...
What is the current status of trial NCT00556439?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 97 participants. The study started on 2008-12. Estimated completion is 2015-08.
What conditions does trial NCT00556439 study?
This clinical trial studies the following conditions: Giant Cell Arteritis, Takayasu's Arteritis.
What interventions are being tested in trial NCT00556439?
The interventions under investigation include: Placebo (DRUG), Abatacept (DRUG).
Who is sponsoring clinical trial NCT00556439?
This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00556439 being conducted?
This trial has 10 study locations across California, Maryland, Massachusetts, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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