Clinical trial: Mycophenolate Sodium Treatment in Patients With Primary Sjogren's Syndrome (NCT00542763)

Eligibility criteria:
Inclusion Criteria:

          -  Diagnosis of primary Sjogren' Syndrome based on the American-European Consensus
             criteria

          -  Erythrocyte sedimentation rate >25mm/h and hypergammaglobulinemia (>1500 mg/dl)

          -  Presence of anti-SS-A and /or SS-B antibodies and / or rheumatoid factor

          -  Requirement of artificial teardrops due to symptomatic sicca syndrome

          -  Inadequate response or intolerance of prior treatment with hydroxychloroquine and / or
             azathioprine

          -  Adequate contraception for females of childbearing potential

        Exclusion Criteria:

          -  Age below 18 or above 75 years

          -  Secondary Sjogren's syndrome

          -  History of cancer, severe infections or other uncontrolled diseases

          -  Treatment with concomitant disease modifying anti-rheumatic drugs within the least 8
             weeks before baseline evaluation

          -  Prednisolone dose of > 5mg/d or changes of prednisolone dose within the least 4 weeks
             before baseline

          -  Use of secretagogues (e.g. pilocarpine, cevimeline) or medications that potentially
             diminish exocrine gland function (e.g. tricyclic antidepressants, anti-cholinergic
             drugs)

          -  Pregnant or lactating women
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? 1