Clinical trial: The Pathogenesis and Natural History of Sjogren s Syndrome (NCT01425892)

Eligibility criteria:
-  INCLUSION CRITERIA:

               1. Ability to sign informed consent form

               2. Fulfilling one the definitions below:

                    1. Sj(SqrRoot)(Delta)gren s defined by European-American (EA) classification
                       criteria for primary or secondary Sj(SqrRoot)(Delta)gren s syndrome (SS
                       group)

                    2. Excluded from the EA criteria because of a comorbid condition but otherwise
                       fulfilling the European-American classification criteria (EA excluded SS
                       group)

                    3. Incomplete SS

                  i. at least 2 of the EA criteria with a common manifestation of SS not included
                  in these criteria (e.g., fatigue, vasculitis, arthritis, etc)

                  ii. 2 or more common manifestations of SS which are not included in the EA
                  criteria (e.g.,: fatigue, vasculitis, arthritis, autonomic dysfunction, etc ) and
                  are not explained by other conditions

                  EXCLUSION CRITERIA:

               1. Age <16 years

               2. inability or unwillingness to comply with follow up requirements

               3. Any medical or psychological/psychiatric condition or treatment that, in the
                  opinion of the Principal Investigator, would exclude the subjects from the
                  research studies (e.g., alternative explanation for subjects signs and symptoms)

               4. NIH employees who report directly to the principal investigator or who are a
                  co-worker or relative of the principal investigator..
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 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