Clinical trial: Anti-CD20 Antibody Therapy for Sjogren's Syndrome (NCT00101829)

Eligibility criteria:
Inclusion Criteria:

          -  Weighs at least 40 kg (88.2 lbs)

          -  Meets European criteria proposed by the American-European Consensus Group for primary
             Sjogren's syndrome

          -  Has 1 or more of the following symptoms of Sjogren's syndrome: fatigue; joint pain;
             peripheral neuropathy; interstitial lung disease; leukocytoclastic vasculitis; renal
             tubular acidosis; interstitial nephritis; severe parotid swelling; or other
             extraglandular manifestations causing organ system dysfunction

          -  Agrees to use acceptable methods of contraception during the study and for 12 months
             after the end of treatment

        Exclusion Criteria:

          -  Active infection

          -  Chronic or persistent infection which might be worsened by immunosuppressive treatment
             (e.g., HIV, hepatitis B or C, tuberculosis [TB])

          -  Known coronary artery disease, significant cardiac arrhythmias, or severe congestive
             heart failure (New York Heart Association class III or IV)

          -  Current use of anticoagulants

          -  Prior use of rituximab

          -  Cyclophosphamide treatment within 24 weeks prior to screening

          -  Certain medications that may cause dry mouth

          -  Cytotoxic therapy with azathioprine, cyclosporine, methotrexate, or mycophenolate
             mofetil within 4 weeks prior to screening

          -  Etanercept within 4 weeks prior to screening

          -  Adalumimab within 8 weeks prior to screening

          -  Infliximab within 12 weeks prior to screening

          -  Prednisone at greater than 10 mg/day within 2 weeks prior to screening. Patients who
             have their steroid doses tapered to 10 mg/day or less within 2 weeks of screening are
             not excluded.

          -  Definitive diagnosis of another autoimmune rheumatologic disease (e.g., systemic lupus
             erythematosus, scleroderma, rheumatoid arthritis)

          -  History of alcohol or substance abuse

          -  History of immunoglobulin E (IgE)-mediated or non-IgE-mediated hypersensitivity

          -  Known anaphylaxis to mouse-derived proteins

          -  History of head and neck radiation therapy

          -  History of sarcoidosis (inflammation of unknown cause occurring in the lymph nodes,
             lungs, liver, eyes, skin, or other tissues)

          -  History of graft-versus-host disease

          -  History of cancer. Patients who have had resected basal or major squamous cell
             carcinoma, cervical dysplasia, or in situ cervical cancer Grade I within the last 5
             years prior to study entry are not excluded.

          -  History of positive PPD without documentation of treatment for TB infection or
             chemoprophylaxis for TB exposure

          -  Live vaccines within the 3 months prior to study entry

          -  Severe pulmonary disease. Patients who do not have undue fatigue or dyspnea following
             ordinary physical activity are not excluded.

          -  Psychiatric disorder precluding informed consent

          -  Inability or unwillingness to follow study requirements

          -  Any current condition or treatment that, in the opinion of the investigator, may
             interfere with the study

          -  Pregnancy
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