Clinical trial: Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis (NCT02531633)

Eligibility criteria:
Inclusion Criteria:

          -  Diagnosis of GCA defined by the following Revised GCA Diagnosis Criteria:

        Age >=50 years. History of ESR >=50 millimeter/hour (mm/hour) or CRP >=2.45
        milligram/deciliter(mg/dL).

        Presence of at least one of the following: Unequivocal cranial symptoms of GCA; Unequivocal
        symptoms of polymyalgia rheumatic (PMR).

        Presence of at least one of the following: Temporal artery biopsy revealing features of
        GCA; Evidence of large-vessel vasculitis by angiography or cross-sectional imaging.

          -  Active GCA within 6 weeks of Randomization (Baseline) where active disease is defined
             by an ESR >=30 mm/hr or CRP >=1 mg/dL AND the presence of at least one of the
             following:

        Unequivocal cranial symptoms of GCA; Unequivocal symptoms of PMR; Other features judged by
        the clinician investigator to be consistent with GCA or PMR flares.

          -  At screening, receiving or able to receive prednisone 20-60 mg/day for the treatment
             of active GCA.

          -  Clinically stable GCA disease at baseline such that the subject is able to safely
             participate in the blinded prednisone taper regimen in the opinion of the
             investigator.

          -  Practicing acceptable methods of birth control if a female of child-bearing potential.

          -  No evidence of active or latent infection with Mycobacterium tuberculosis (TB).

        Exclusion Criteria:

          -  Are pregnant or breastfeeding.

          -  Recent (within the past 12 weeks) or planned major surgery that would impact on study
             procedures or assessments.

          -  Organ transplantation recipients (except corneas within 3 months prior to baseline
             visit).

          -  Had prior treatment with any of the following:

        Systemic immunosuppressives) within 4 weeks of baseline; Biologic agents targeted at
        reducing tumor necrosis factor-alpha (TNF-alpha) within 2-8 weeks of baseline, depending on
        the agent; Any prior use of tocilizumab or other anti-IL-6 agents; B-cell depleting agents
        (eg, rituximab) within 12 months prior to baseline or longer if B cell counts have not
        returned to normal range or baseline levels; Cytotoxic drugs such as cyclophosphamide,
        chlorambucil, nitrogen mustard, or other alkylating agents within 4 weeks of baseline;
        Abatacept within 8 weeks of baseline; Tofacitinib within 4 weeks of baseline; Methotrexate
        use within 2 weeks of baseline.

        Methylprednisolone > 100 mg/day intravenous (IV) (or equivalent) within 8 weeks of
        baseline.

          -  History of severe allergic reactions to monoclonal antibodies, human proteins, or
             excipients.

          -  Evidence of serious concomitant disease, which in the opinion of the investigator
             makes them unsuitable for participation in the study.

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

          -  Marked baseline prolongation of corrected QT (QTc) interval >= 450 milliseconds (msec)
             (QTc by Bazett's formula [QTcB ]or QTc by Fridericia's formula [QTcF] ), history of
             Torsade de Pointes, family history of long QT syndrome, history of second or third
             degree heart block.

          -  Current liver disease that could interfere with the trial

          -  History of or current active diverticulitis, inflammatory bowel disease, or other
             symptomatic gastrointestinal tract condition that might predispose to bowel
             perforation.

          -  History of known demyelinating diseases such as multiple sclerosis or optic neuritis.

          -  Active infections, or history of recurrent infections or have required management of
             acute or chronic infections, as follows:

        Currently on any suppressive therapy for a chronic infection, history or suspicion of
        chronic infection, hospitalization for treatment of infection within 60 days of the
        baseline visit, or use of parenteral (IV) or intra-muscular [IM]) antimicrobials within 60
        days of baseline or oral antimicrobials within 30 days of baseline

          -  Primary or secondary immunodeficiency or any other autoimmune disease.

          -  Human immunodeficiency virus (HIV) infection, hepatitis C or hepatitis B infection

          -  Live virus or bacterial vaccination within 3 months before the first administration of
             study drug
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