Clinical trial: Tolerance and Efficacy of Rituximab in Sjogren's Disease (NCT00740948)

Eligibility criteria:
Inclusion Criteria:

          -  they fulfill the new American-European Consensus Group criteria for pSS and have :

          -  a recent (less than 10 years) and active disease as assessed by :

          -  values > 50 mm on 2 of 4 visual analogue scales (VAS) (0-100mm) that evaluated global
             scores of the disease (activity of the disease including extra glandular
             manifestations), pain, sicca syndrome and fatigue over the last week.

          -  Rheumatoid factor or anti SSA>1.5N or cryoglobulinemia or

          -  hypergammaglobulinemia or high level of beta2 microglobulinemia or

          -  hypocomplémentemia.

          -  and/or at least one of the following severe signs:

               -  parotidomegaly,

               -  arthritis,

               -  purpura,

               -  pulmonary involvement,

               -  tubulopathy,

               -  neurological involvement,

        informed consent age 18-80 years, stable non-steroidal anti-inflammatory drugs and no
        prescription of immunosuppressive agents for at least 4 weeks prior to inclusion Use of a
        reliable mean of contraception (for patients of reproductive potential)

        Exclusion Criteria:

          -  Patients should be excluded if they have a secondary SS,

          -  if they received cytotoxic drugs during the previous 4 months,

          -  if they have severe renal or haematological failure, a history of cancer, hepatitis B
             or C, HIV, tuberculosis, severe diabetes or any other chronic disease or evidence of
             infection,

          -  if they have had severe allergic or anaphylactic reactions to humanized or murine
             monoclonal antibodies

          -  or if they are unable to understand the protocol.

          -  Other : neutrophil count < 1.5 x 103/L, live/attenuated vaccine within 28 days prior
             to baseline, pregnancy, breast feeding,
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 80 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