Clinical trial: Tocilizumab for Patients With Giant Cell Arteritis (NCT01450137)

Eligibility criteria:
Inclusion Criteria:

          -  Patients with newly onset or relapsed GCA

          -  > 50 years of age

          -  satisfying ACR criteria

          -  elevated sedimentation rate above 40 mm

          -  CRP > 20 mg/L

          -  Patients with histologically proven GCA or with large vessel vasculitis assessed by
             MRI

        Exclusion Criteria

          -  Rheumatic diseases (except for CPPD/chondrocalcinosis) other than GCA/Takayasu disease
             or polymyalgia rheumatica (i.e., RA, autoimmune connectivitides, other systemic
             vasculitides, a.o.)

          -  Evidence of significant and/or uncontrolled concomitant disease

          -  Diagnosis of GCA > 4 weeks before screening visit and beginning of GC treatment > 4
             weeks before screening (only valid for new onset GCA), or when a patient received
             treatment with tocilizumab or with other biological agents (such as TNFα-blockers)
             within 3 months before screening

          -  Any condition or general state of health which, in the Investigator's opinion, would
             preclude participation in the study

          -  Actual or recent myocardial infarction (within the last 3 months before screening
             visit)

          -  Significant cardiac disease (NYHA Class III and IV), known severe chronic obstructive
             pulmonary disease (COPD) (FEV1 < 50% predicted or Functional dyspnoea > Grade 3 on the
             MRC Dyspnoea Scale) or other significant pulmonary disease

          -  Uncontrolled disease (such as asthma, psoriasis or inflammatory bowel disease) where
             flares are commonly treated with oral or injectable corticosteroids

          -  Known active infection of any kind, or any major episode of infection requiring
             hospitalization or treatment with i.v. anti-infectives within 4 weeks of baseline or
             completion of oral anti-infectives within 2 weeks prior to baseline

          -  History of deep space/tissue infection (e.g. fasciitis, abscess, osteomyelitis) within
             52 weeks prior to baseline

          -  Any surgical procedure, including bone/joint surgery within 8 weeks prior to baseline
             or planned within the duration of the study

          -  History of serious recurrent or chronic infection (for screening for a chest infection
             a chest radiograph will be performed at screening if not performed within 12 weeks
             prior to screening)

          -  Lack of peripheral venous access

          -  Body weight > 150 kg or BMI > 35

          -  Previous treatment with tocilizumab or any other biological agent

          -  Treatment with any investigational agent within 28 days of screening or 5 half-lives
             of the investigational drug (whichever is the longer)

          -  History of severe allergic or anaphylactic reaction to any biologic agent or known
             hypersensitivity to any component of tocilizumab (RoActemra)

          -  Receipt of any vaccine within 28 days prior to baseline (a patient's vaccination
             record and need for immunization prior to receiving tocilizumab/placebo must be
             carefully investigated)

          -  Positive tests for hepatitis B surface antigen (HBsAg), Hepatitis B core antibody
             (HbcAb) or hepatitis C serology

          -  Positive Quantiferon-TB® test for latent Tb without subsequent INH prophylaxis

          -  Patients with active Tb which had to be treated for Tb within 2 years before the
             screening visit
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