Clinical trial: Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA (NCT03600805)

Eligibility criteria:
Inclusion criteria :

          -  Diagnosis of giant cell arteritis (GCA) according to European League Against
             Rheumatism/American College of Rheumatology classification criteria.

          -  New onset active disease or refractory active disease.

          -  At least one of the symptoms of GCA within 6 weeks of baseline.

          -  Either erythrocyte sedimentation rate ≥30 mm/hour or C-reactive protein ≥10 mg/L
             within 6 weeks of baseline.

          -  Receiving or able to receive prednisone 20-60 mg/day for the treatment of active GCA.

        Exclusion criteria:

          -  Organ transplantation recipient (except corneas, unless it is within 3 months prior to
             baseline visit).

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

          -  Any prior use of the following therapies, for the treatment of GCA:

          -  Janus kinase inhibitor (e.g., tofacitinib) within 4 weeks of baseline.

          -  Cell-depletion agents (e.g., anti CD20) without evidence of recovery of B cells to
             baseline level.

          -  Abatacept within 8 weeks of baseline.

          -  Anakinra within 1 week of baseline.

          -  Tumor necrosis factor inhibitors within 2-8 weeks (etanercept within 2 weeks;
             infliximab, certolizumab, golimumab, or adalimumab within 8 weeks), or less than at
             least 5 half-lives have elapsed prior to baseline, whichever is longer.

          -  Therapeutic failure, including inadequate response or intolerance, or
             contraindication, to biological IL-6/(R) antagonist (prior experience with IL-6/(R)
             antagonist that was terminated for reasons unrelated to therapeutic failure at least 3
             months before baseline is not exclusionary).

          -  Use of any alkylating agents including cyclophosphamide within 6 months of baseline.

          -  Use of immunosuppressant, such as hydroxychloroquine, cyclosporine, azathioprine,
             mycophenolate mofetil or leflunomide within 4 weeks of baseline. (Use of methotrexate
             (MTX) not exceeding 25 mg per week and have been stable for at least 3 months prior to
             baseline is not exclusionary).

          -  Concurrent use of systemic corticosteroids (CS) for conditions other than GCA.

          -  Use of IV CS at a dose equivalent to 100 mg of methylprednisolone or higher within 8
             weeks of baseline for GCA therapy.

          -  Pregnant or breastfeeding woman.

          -  Patients with active or untreated latent tuberculosis.

          -  Patients with history of invasive opportunistic infections.

          -  Patients with fever associated with infection or chronic, persistent or recurring
             infections requiring active treatment.

          -  Patients with uncontrolled diabetes mellitus.

          -  Patients with non-healed or healing skin ulcers.

          -  Patients who received any live, attenuated vaccine within 3 months of baseline.

          -  Patients who are positive for hepatitis B, hepatitis C and/or HIV.

          -  Patients with a history of active or recurrent herpes zoster.

          -  Patients with a history of or prior articular or prosthetic joint infection.

          -  Prior or current history of malignancy.

          -  Patients who have had surgery within 4 weeks of screening or planned surgery during
             study.

          -  Patients with a history of inflammatory bowel disease or severe diverticulitis or
             previous gastrointestinal perforation..

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.
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