Clinical trial: A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's Syndrome (NCT02701985)

Eligibility criteria:
Inclusion Criteria:

          -  A diagnosis of primary Sjogren's syndrome according to the revised American-European
             Consensus Group (AECG) criteria

          -  ESSDAI score greater than or equal to (>/=) 5

          -  ESSPRI score >/=5

          -  Elevated serum titers of anti-Sjogren's-syndrome-related antigen A (anti-SSA) and/or
             anti-Sjogren's-syndrome-related antigen B (anti-SSB) antibodies at screening

          -  Negative pregnancy test at screening and baseline (for women only)

          -  Willing to comply with the study procedures and restrictions, including measures to
             prevent pregnancy and restrictions on sperm donation

        Exclusion Criteria:

          -  A diagnosis of secondary Sjogren's syndrome according to the revised AECG criteria

          -  Severe complications of Sjogren's syndrome

          -  Systemic immunosuppressant therapy, cyclophosphamide, or B-cell depleting therapy
             within 6 months prior to the screening visit

          -  Corticosteroid therapy exceeding 7.5 mg prednisone equivalents per day

          -  A positive test result for hepatitis B (HBV), hepatitis C (HCV), or human
             immunodeficiency virus (HIV), or tuberculosis, or any other active viral, fungal,
             yeast or bacterial infection at screening

          -  A history suggesting reduced immune function or any other conditions predisposing
             participants to serious infection

          -  A history of lymphoma, myeloma or monoclonal gammopathy of unknown significance
             (MGUS), or any other malignancies within the past 5 years

          -  A diagnosis of fibromyalgia or significant depression

          -  Having any concomitant disease or condition that could interfere with the conduct of
             the study, or that would pose an unacceptable risk to the individual

          -  Participation in an investigational drug or device study within 3 months prior to
             screening

          -  Inability to comply with the study protocol for any other reason

          -  Women who are lactating, breastfeeding or planning to nurse

          -  Using other prohibited medication (moderate or potent inhibitors of CYP3A4; strong
             inducers of CYP3A4; strong inhibitors of the transporter P-glycoprotein [P-gp];
             sensitive substrates of CYP3A4 with a narrow therapeutic index)
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