Clinical trial: Adelphi Primary Sjogren's Syndrome (pSS) Disease Specific Programme (DSP) (NCT03501420)

Eligibility criteria:
Inclusion Criteria:

        Physician eligibility criteria:

          -  Primary physician specialty identified as Rheumatologist

          -  Physicians who currently treat 7 or more pSS subjects in a typical month

          -  Physicians who are actively involved in the management and treatment decisions of pSS
             subjects

        Subject eligibility criteria:

          -  Subjects with a diagnosis of Sjogren's syndrome in the opinion of the rheumatologist
             in the absence of Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA) or
             Systemic Sclerosis.

          -  For main sample (6 subjects per rheumatologist)

          -  Subjects with age >=18 years and with confirmed diagnosis of pSS and are currently, or
             have previously, exhibited disease activity in one or more of the categories: fever of
             non-infectious origin, lymphadenopathy/lymphoma, glandular swelling/enlarged parotid
             gland, arthralgia/synovitis, erythema/vasculitis/purpura, pulmonary involvement, renal
             involvement, myositis, peripheral nervous system involvement, central nervous system
             involvement, cytopenia of autoimmune origin (with neutropenia) and/or anemia and/or
             thrombocytopenia and/or lymphopenia, hypocomplementemia and/or hypergammaglobulinemia
             and/or cryoglobulinemia or hypogammaglobulinemia and/or Ever received
             immunosuppressant or biologic treatment.

          -  For oversample (1 subject per rheumatologist)

          -  Subjects with age >=18 years and with confirmed diagnosis of pSS that fit the
             following criteria: Has never exhibited disease activity in any of the categories
             above, Moderate or severe fatigue (in the opinion of the rheumatologist)

        Exclusion Criteria:

          -  Not applicable
No condition on gender to be admitted to 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