Clinical trial: Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients (NCT04605978)

Eligibility criteria:
Inclusion Criteria:

          1. Diagnosis of primary Sjögren's Syndrome based on 2016 American College of
             Rheumatology-EULAR criteria

          2. ESSDAI total score ≥ 6 during screening, with at least 6 points scored within the 7
             following domains: constitutional, lymphadenopathy, glandular, articular, cutaneous,
             hematologic and biologic,

          3. Positive anti-Sjögren's Syndrome A (Ro) antibodies or anti-nuclear antibodies (ANA) ≥
             1:320 or rheumatoid factor (RF) >20 IU/ml during screening period, measured in a
             central laboratory

          4. Stimulated whole salivary flow rate > 0 mL/minute

        Exclusion Criteria:

          1. Prior administration within the timeframe described in the protocol of any of the
             following:

               -  Belimumab,

               -  Rituximab or other B cell depleting agents,

               -  Abatacept,

               -  Tumor necrosis factor inhibitors,

               -  Tocilizumab,

               -  Cyclophosphamide,

               -  Cyclosporine (except for eye drops), tacrolimus, sirolimus, mycophenolate mofetil
                  (MMF), azathioprine, or leflunomide.

          2. Meeting any of the following conditions:

               -  Corticosteroids: > 10 mg/day oral prednisone (or equivalent) within 4 weeks prior
                  to randomisation (W000); Any change or initiation of new dose of oral prednisone
                  (or equivalent) within 4 weeks prior to randomisation (W000); Intramuscular, IV,
                  or intra-articular corticosteroids within 4 weeks prior to randomisation (W000);
                  Any change or initiation of new dose of topical corticosteroids within 2 weeks
                  prior to randomisation (W000),

               -  Antimalarials: any change or initiation of new dose of antimalarials (e.g.
                  chloroquine, hydroxychloroquine, quinacrine) within 16 weeks prior to
                  randomisation (W000),

               -  Methotrexate: > 25 mg/week of methotrexate; any initiation or change of dose of
                  methotrexate within 12 weeks prior to randomisation (W000); any change in route
                  of administration within 4 weeks prior to randomisation (W000),

               -  Non-steroidal anti-inflammatory drugs (NSAIDs): Any change or initiation of new
                  dose of regularly scheduled NSAIDs within 2 weeks prior to randomisation (W000),

               -  Cevimeline or pilocarpine and cyclosporine eye drops (Restasis) and lifitegrast:
                  any increase or initiation of new doses within 2 weeks prior to randomisation
                  (W000).

          3. Secondary Sjögren's Syndrome
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.
Subject must be at most 75 Years

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