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)

Withdrawn before enrolling · Phase 3 · Has a placebo group

Conditions studied: Giant Cell Arteritis

In brief

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.

Key facts

Study ID

NCT03192969

Run by

Bristol-Myers Squibb

People needed

0

Starts

2017-07-15

Expected to finish

2021-11-23

Last updated by the study team

2017-07-12

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution — Fullerton, California, United States
• Local Institution — West Hollywood, California, United States
• Local Institution — Denver, Colorado, United States
• Local Institution — Iowa City, Iowa, United States
• Local Institution — Kansas City, Kansas, United States
• Local Institution — Rochester, Minnesota, United States
• Local Institution — New York, New York, United States
• Local Institution — Cleveland, Ohio, United States
• Local Institution — Dayton, Ohio, United States
• Local Institution — Philadelphia, Pennsylvania, United States
• Local Institution — Charleston, South Carolina, United States
• Local Institution — Beaumont, Texas, United States
• Local Institution — Northmead, New South Wales, Australia
• Local Institution — Auchenflower, Queensland, Australia
• Local Institution — Woodville South, South Australia, Australia
• Local Institution — Malvern East, Victoria, Australia
• Local Institution — Nedlands, Western Australia, Australia
• Local Institution — Victoria Park, Western Australia, Australia
• Local Institution — Graz, Austria
• Local Institution — Stockerau, Austria
• Local Institution — Leuven, Belgium
• Local Institution — Liège, Belgium
• Local Institution — Yvoir, Belgium
• Local Institution — Sofia, Sofia-Grad, Bulgaria
• Local Institution — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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