Clinical trial: A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis (NCT04633447)

Eligibility criteria:
Inclusion criteria

          -  Diagnosis of Giant cell arteritis (GCA) according to the revised American College of
             Rheumatology criteria

          -  GCA diagnosis confirmed by either temporal artery biopsy revealing features of GCA; or
             evidence of cranial GCA by doppler-ultrasound; or cranial Magnetic Resonance Imaging
             or Magnetic Resonance Angiography; or other imaging modality upon agreement with the
             sponsor

          -  Have new onset or relapsing GCA

          -  Have active GCA within 6 weeks of first study intervention: Active GCA: presence of
             signs and symptoms of GCA and elevated erythrocyte sedimentation rate (ESR) greater
             than or equal to (>=) 30 millimeter per hour (mm/hour), or C-reactive protein (CRP) >=
             10 milligrams per liter (mg/L) (or 1 milligrams per deciliter [mg/dL]), attributed to
             active GCA. ESR >= 30 mm/hour or CRP >= 10 mg/L (or 1 mg/dL) is not required if active
             GCA has been confirmed by a positive temporal artery biopsy or ultrasound or other
             imaging modality within 6 weeks of first study intervention

          -  Clinically stable GCA disease on a glucocorticoid (GC) dose between 20 and 60
             milligrams per day (mg/day) (prednisone or equivalent) at randomization such that the
             participant is able to safely participate in the protocol defined prednisone taper
             regimen, in the opinion of the investigator

        Exclusion criteria

          -  Has any known severe or uncontrolled GCA complications

          -  Has any rheumatic disease other than GCA such that could interfere with assessment of
             GCA

          -  Has a current diagnosis or signs or symptoms of severe, progressive, or concomitant
             medical condition that places the participant at risk by participating in this study)

          -  Has or has had any major ischemic event, within 12 weeks of first study intervention

          -  Has any comorbidities requiring 3 or more courses of systemic GCs within 12 months of
             first study intervention, AND, inability, in the opinion of the investigator, to
             withdraw GC therapy through protocol-defined taper regimen due to suspected or
             established adrenal insufficiency, OR, currently on systemic chronic GC therapy for
             reasons other than GCA and be GC dependent and have the potential to flare due to GC
             tapering (e.g. unstable asthma, unstable COPD)

          -  Has a history of, or ongoing, chronic or recurrent infectious disease

          -  Has received within specified timeframe, or 5 half-lives (whichever is greater) , or
             has failed treatment with any investigational or approved biologic agents or Janus
             Kinase Inhibitor prior to first study intervention

          -  Use of any of the following systemic immunosuppressant treatments within the specified
             timeframe prior to study start: Any cytotoxic agents (cyclophosphamide, chlorambucil,
             nitrogen mustard, or other alkylating agents) with 6 months; Hydroxychloroquine,
             cyclosporine A, azathioprine, tacrolimus, sirolimus, sulfasalazine, leflunomide with
             cholestyramine washout or mycophenolate mofetil/mycophenolic acid within 3 months;
             Intramuscular, intra-articular, intrabursal, epidural, intra-lesional or IV GCs within
             6 week; and Methotrexate (MTX) within 12 weeks. If started MTX >12 weeks prior to
             first study intervention MTX must have been at a stable dose for minimally 6 weeks and
             must not be receiving more than 20 mg oral MTX (or 15 mg SC) per week

          -  Has chronic continuous use of systemic GCs for greater than (>) 4 years or inability,
             in the opinion of the investigator, to withdraw GC treatment through protocol-defined
             taper regimen due to suspected or established adrenal insufficiency
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