Clinical trial: Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjögren's Syndrome (NCT03905525)

Eligibility criteria:
Inclusion Criteria:

          -  Signed informed consent

          -  Male or female patient ≥ 18 years of age

          -  Classification of Sjögren's Syndrome according to ACR/EULAR 2016 criteria (Shiboski et
             al 2017)

          -  Seropositive for anti-Ro/SSA antibodies

          -  Stimulated whole salivary flow rate of ≥ 0.1 mL/min

        Inclusion criteria specific for Cohort 1:

          -  ESSDAI ≥ 5 within the 8 predefined organ domains

          -  ESSPRI score of ≥5

        Inclusion criteria specific for Cohort 2:

          -  ESSDAI < 5 within 8 domains scored for inclusion criterion for Cohort 1

          -  ESSPRI fatigue subscore ≥ 5 or ESSPRI dryness subscore ≥ 5

        Exclusion Criteria:

          -  Sjögren's Syndrome overlap syndromes where another autoimmune rheumatic disease
             constitutes the principle illness

          -  Use of other investigational drugs

          -  Prior use of B cell depleting therapies, abatacept or any other immunosuppressants
             unless specifically allowe be the protocol.

          -  Use of steroids at dose >10 mg/day.

          -  Uncontrolled ocular rosacea (affecting the eye adnexa), posterior blepharitis or
             Meibomian gland disease (this criterion applies only to patients considered for Cohort
             2)

          -  Active viral, bacterial or other infections requiring systemic treatment

          -  Receipt of live/attenuated vaccine within a 2-month period prior to randomization.

          -  Chronic infection with hepatitis B (HBV) or hepatitis C (HCV).

          -  Evidence of active tuberculosis (TB) infection.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn.  The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness.  She also reports occasional joint pain.  Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease.  She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h)

Patient description (patient's own words): I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR.

Does the patient match the trial criteria? Entailment