Clinical trial: An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA) (NCT01791153)

Eligibility criteria:
Inclusion Criteria:

          -  Diagnosis of GCA classified according to age >/=50 years; history of ESR >/=50 mm/hr
             or history of CRP >/=2.45 mg/dL; and at least one of the following: unequivocal
             cranial symptoms of GCA or symptoms of polymyalgia rheumatica [PMR]; and 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

          -  New onset (diagnosis within 6 weeks of baseline) or refractory (diagnosis greater than
             [>] 6 weeks before baseline and previous treatment with >/= 40 milligrams per day
             prednisone [or equivalent] for at least 2 consecutive weeks at any time) GCA

          -  Active disease (presence of clinical signs and symptoms [cranial or PMR] and ESR >/=30
             mm/hour or CRP >/=1 mg/dL) within 6 weeks of baseline visit

        Exclusion Criteria:

          -  Major surgery within 8 weeks prior to screening or planned within 12 months after
             randomization

          -  Transplanted organs (except corneas with transplant performed >3 months prior to
             screening)

          -  Major ischemic event, unrelated to GCA, within 12 weeks of screening

          -  Prior treatment with any of the following: investigational agent within 12 weeks (or 5
             half-lives of the investigational drug, whichever is longer) of screening;
             cell-depleting therapies including investigational agent; intravenous (IV) gamma
             globulin or plasmapheresis within 6 months of baseline; alkylating agents or with
             total lymphoid irradiation; tocilizumab; hydroxychloroquine, cyclosporine A,
             azathioprine, or mycophenolate mofetil within 4 weeks of baseline; etanercept within 2
             weeks of baseline; infliximab, certolizumab, golimumab, abatacept, or adalimumab
             within 8 weeks of baseline; anakinra within 1 week of baseline; tofacitinib;
             cyclophosphamide within 6 months of baseline; >100 milligrams of daily IV
             methylprednisolone within 6 weeks of baseline

          -  Participants requiring systemic glucocorticoids for conditions other than GCA, which,
             in the opinion of the investigator, would interfere with adherence to the fixed
             glucocorticoid taper regimen and/or to assessment of efficacy in response to the test
             article

          -  History of severe allergic reactions to monoclonal antibodies or to prednisone

          -  Evidence of serious uncontrolled concomitant disease (for example, cardiovascular,
             respiratory, renal, endocrine, psychiatric, corneal ulcers/injuries, or
             gastrointestinal [GI] disease)

          -  Current liver disease, as determined by the investigator

          -  History of diverticulitis, inflammatory bowel disease, or other symptomatic GI tract
             condition that might predispose to bowel perforation

          -  Known active or history of recurrent bacterial, viral fungal, mycobacterial, or other
             infection

          -  Primary or secondary immunodeficiency

          -  Evidence of malignancies diagnosed within previous 5 years (except basal and squamous
             cell carcinoma of the skin or carcinoma in situ of the cervix uteri that have been
             excised and cured)

          -  Inadequate hematologic, renal or liver function

          -  Positive for hepatitis B or hepatitis C infection
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