Clinical trial: 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) (NCT03192969)

Eligibility criteria:
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        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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.


Patient description (medical language): A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing.  He also complains of fatigue and hip muscle aches over the last several months.  The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications.  On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min.  Neurological examination is unremarkable.  Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation.

Patient description (patient's own words): I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage.

Does the patient match the trial criteria? 1