A Study to Evaluate Efficacy and Safety of Subcutaneous Abatacept With Steroid Treatment Compared to Steroid Treatment Alone in Adults With Giant Cell Arteritis (GCA)



Status:Not yet recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:50 - Any
Updated:6/21/2017
Start Date:July 15, 2017
End Date:November 23, 2021
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Email:Clinical.Trials@bms.com
Phone:please email:

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A Phase III Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Combination With Glucocorticoid Treatment Compared to Glucocorticoid Monotherapy in Adults With Giant Cell Arteritis

To investigate the safety and efficacy of abatacept with steroid treatment in comparison to
steroid treatment alone in up to a 28 week taper of steroid treatment to sustain remission
of Giant Cell Arteritis in adults.


For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- New headache (new onset or new type of localized pain in the head)

- Elevated ESR (≥ 50 mm/h by the Westergren method) or CRP ≥ 1 mg/dL

- Temporal artery abnormality (i.e. temporal artery tenderness to palpation or
decreased pulsation, unrelated to arteriosclerosis of cervical arteries)

- Temporal artery biopsy showing vasculitis characterized by a predominance of
mononuclear cell infiltration or granulomatous inflammation, usually with
multinucleated giant cells

- Large vessel biopsy showing vasculitis characterized by a predominance of mononuclear
cell infiltration or granulomatous inflammation, usually with multinucleated giant
cells or characteristic changes of large vessel stenosis or aneurysm secondary to GCA
as seen by arteriography (Magnetic Resonance Imaging/ Magnetic Resonance
Angiography), ultrasound (eg, halo sign on color duplex sonography), or CT scan

- Patients must be treated with prednisone or prednisolone of 20-60 mg/day (prednisone
equivalent) and be on a dose between 20-60 mg/day for at least 2 weeks prior to
enrollment into the study

Exclusion Criteria:

- Rheumatic disease other than GCA such as Takayasu's Arteritis, granulomatosis with
polyangiitis (Wegener's), rheumatoid arthritis, systemic lupus erythematosus

- Patients with unilateral blindness (partial or complete) or who have unstable or
recurrent visual symptoms attributable to GCA within 4 weeks of randomization

- Patients with a history of dissection of aorta

- Patients with a history of myocardial infarction, stroke or transient ischemic attack
attributable to GCA within the 3 months of screening

- Patients who have been treated with intravenous ("pulse") doses of glucocorticoids
defined as methylprednisolone > 1000 mg/day if given within 6 weeks of randomization

- Patients who will require oral or IV glucocorticoid treatment during the trial for
conditions other than GCA

- Patients at risk of tuberculosis

Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
13
sites
Denver, Colorado 80220
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Charleston, South Carolina 29425
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Charleston, SC
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Cleveland, Ohio 44195
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Cleveland, OH
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Dayton, Ohio
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Dayton, OH
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Fullerton, California 92835
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Fullerton, CA
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Iowa City, Iowa 52242
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Iowa City, IA
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Kansas City, Kansas 66160
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Kansas City, KS
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New York, New York 10016
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New York, NY
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19 Campbell Street
Northmead, New South Wales 2152
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Northmead,
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Philadelphia, Pennsylvania 19102
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Philadelphia, PA
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Phoenix, Arizona 85016
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Phoenix, AZ
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Rochester, Minnesota 55905
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Rochester, MN
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9201 Sunset Boulevard
West Hollywood, California 90069
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West Hollywood, CA
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