Clinical trial: A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (NCT03725202)

Eligibility criteria:
Inclusion Criteria:

          -  Diagnosis of giant cell arteritis (GCA) according to the following criteria:

               -  History of erythrocyte sedimentation rate (ESR) >= 50 mm/hour or high sensitivity
                  C-reactive protein (hsCRP)/CRP >=1.0 mg/dL

               -  Presence of at least one of the following: Unequivocal cranial symptoms of GCA or
                  Unequivocal symptoms of polymyalgia rheumatica (PMR)

               -  Presence of at least one of the following: Temporal artery biopsy revealing
                  features of GCA or evidence of large vessel vasculitis by angiography or
                  cross-sectional imaging such as ultrasound, magnetic resonance imaging (MRI),
                  computed tomography (CT) or positron emission tomography (PET).

          -  Active GCA, either new onset or relapsing, within 6 weeks of Baseline.

          -  Participants must have received treatment with >=40 mg prednisone (or equivalent) at
             any time prior to Baseline and be receiving prednisone (or equivalent) >= 20 mg once
             daily (QD) at Baseline.

          -  Participants must have GCA that, in the opinion of the investigator, is clinically
             stable to allow the participant to safely initiate the protocol-defined corticosteroid
             (CS) taper regimen.

          -  Females must either be postmenopausal or permanently surgically sterile or, practicing
             at least 1 specified method of birth control through the study.

        Exclusion Criteria:

          -  Prior exposure to any Janus Kinase (JAK) inhibitor.

          -  Treatment with an interleukin-6 (IL-6) inhibitor within 4 weeks of study start, or
             prior treatment with an IL-6 inhibitor and experienced a disease flare during
             treatment.

          -  Use of any of the following systemic immunosuppressant treatments within the specified
             timeframe prior to study start:

               -  Anakinra within 1 week of study start.

               -  Methotrexate, hydroxychloroquine, cyclosporine, azathioprine, or mycophenolate
                  within 4 weeks of study start.

               -  Oral corticosteroid (CS) for conditions other than GCA within 4 week of study
                  start, or intravenous CS within 4 weeks of study start.

               -  Greater than or equal to 8 weeks for leflunomide if no elimination procedure was
                  followed, or adhere to an elimination procedure.

               -  Cell-depleting agents or alkylating agents including cyclophosphamide within 6
                  months of study start.

          -  Current or past history of infection including herpes zoster or herpes simplex, HIV,
             active Tuberculosis, active or chronic recurring infection, active hepatitis B or C.

          -  Female who is pregnant, breastfeeding, or considering pregnancy during the study.
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