Clinical trial: FDG Uptake in Large-Vessel Giant Cell Arteritis After Short-term, High-Dose Steroid Treatment (NCT03285945)

Eligibility criteria:
Inclusion Criteria:

          1. Clinical suspicion of GCA; Cranial symptoms, new-onset extremity claudication or
             protracted constitutional symptoms (weight loss > 5 kilograms or fever >38C for > 3
             weeks).

          2. C reactive protein >15 mg/l or erythrocyte sedimentation rate >40 mm/h

          3. FDG PET/CT verified LV-GCA (steroid-naive) defined by FDG uptake in the aortic wall
             and/or supra-aortic branches with FDG uptake score ≥3.

        Exclusion Criteria:

          1. oral glucocorticoid treatment within the past month

          2. subcutaneously, intramuscularly, intraarticularly or intravenously administered
             glucocorticoid within the past 2 months

          3. treatment with DMARDs or other immunosuppressive therapy ongoing or within the past 3
             months

          4. ongoing treatment with interleukin2

          5. any disease mimicking GCA, including

               -  a) autoimmune diseases with possible aortitis; rheumatoid arthritis, Cogans
                  syndrome, relapsing polychondritis, ankylosing spondylitis, systemic lupus
                  erythematosus, Buerger's disease, Bechet's disease, inflammatory bowel disease

               -  b) infections with possible aortitis: syphilis, known active current or history
                  of recurrent tuberculosis, hepatitis or HIV

               -  c) other large-vessel disease: sarcoidosis, neurofibromatosis, congenital
                  coarctation, Marfans syndrome, Ehlers-Danlos syndrome, retroperitoneal fibrosis

          6. body weight of >150 kg.

          7. Previously diagnosed and treated for PMR or GCA
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? Entailment