Clinical trial: Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study. (NCT01910038)

Eligibility criteria:
Inclusion Criteria:

          -  Age > 50 years

          -  GCA fulfilling ≥3/5 ACR criteria

          -  Newly diagnosed GCA or relapsing GCA if treatments
             (Glucocorticoids±immunosuppressants) have been stopped for at least 6 months

          -  Glucocorticoids started for less than 21 days

          -  Proof of large vessel vasculitis:

               -  Positive temporal artery biopsy (TAB)

               -  Aortitis, as defined by regular circumferential wall thickening ≥3mm in the
                  absence of calcification and/or significant atheroma on angio-CT images; or a
                  homogeneous vascular signal more intense than the liver on 18FDG-PET images.

          -  For men and women of a child-bearing age, an effective method of contraception must be
             used by the patient or his or her partner throughout the treatment with tocilizumab
             (or placebo) and for 3 months after the end of the treatment. Breast-feeding is not
             authorised until 3 months after the end of treatment with tocilizumab. Women not
             considered at risk of pregnancy are those defined by menopause of at least one year or
             surgically steriles (ligature of the fallopian tubes, bilateral ovariectomy or
             hysterectomy)

          -  Persons who have provided written informed consent

          -  Persons covered by the National Health Insurance Agency

        Exclusion Criteria:

          -  Pregnancy

          -  hospitalization in the previous year for drug or alcohol intoxication

          -  current treatment for another autoimmune or inflammatory disease

          -  known hypersensitivity to TCZ or one of its excipients or another human or murine
             monoclonal antibody

          -  treatment with anti-TNF-α, methotrexate, cyclophosphamide, dapsone, methylprednisolone
             pulses or any other immunosuppressive or immunomodulatory drug or biotherapy within 6
             months before inclusion

          -  long-course systemic GC therapy

          -  prednisone therapy >1 mg/kg/day, whatever the duration

          -  serious or chronic proven infections requiring hospitalization or intravenous
             antibiotics within 30 days before inclusion

          -  other proven infections that required antibiotics within 14 days before inclusion

          -  opportunistic infections

          -  evidence of active tuberculosis or latent tuberculosis (as deﬁned by a positive
             interferon gamma release assay)

          -  active chronic hepatitis B or C or HIV

          -  cancer or lymphoproliferative disorders within the 5 years before inclusion (with the
             exception of in situ cervical cancer and squamous or basal cell carcinoma with R0
             resection)

          -  past history of sigmoid diverticulitis

          -  any active hepatic disease

          -  hepatic failure; thrombocytopenia <50 G/L

          -  neutropenia <0.5 G/L

          -  history of moderate to severe congestive heart failure or demyelinating disease

          -  recent stroke

          -  current signs or symptoms of severe, progressive, or uncontrolled disease, not due to
             GCA, which contraindicates TCZ

          -  severe and uncontrolled hypercholesterolemia

          -  high cardiovascular risk (former cerebral or coronary vascular event, or vascular risk
             >20% at 10 years according to the Framingham risk score [24]); dementia; non-compliant
             patients

          -  patients under ward of court, tutelage or legal guardianship.
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