Clinical trial: Abatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II Study (NCT02027298)

Eligibility criteria:
Inclusion Criteria:

          1. Diagnosis of Sjogren's Syndrome

          2. Patients are at least 18 years or older

          3. Patients should have either pSS and/or sSS associated with RA, and must have active
             moderate to severe inflammatory arthritis as defined by painful joint counts (≥5) and
             swollen joint counts (≥5), or DAS28 scores>3.2.

          4. One non-biologic DMARD will be permitted.

          5. These patients will be willing and able to comply with treatment and follow-up
             procedures.

          6. These patients will be willing and able to provide written informed consent.

          7. Both women and men of child bearing age must be willing to use an effective means of
             birth control while receiving treatment throughout participation in this study.
             Effective contraception methods include abstinence, oral contraceptives (birth control
             pills), IUD, diaphragm, Norplant, approved hormone injections, condoms, or medical
             sterilization.

        Exclusion Criteria:

          1. Patients will be excluded if they have a concomitant disorder requiring systemic
             glucocorticoid (GC) therapy (prednisone >10 mg daily or GC equivalent), have
             organ-threatening features, and have any investigational drug including biologics
             within 28 days of study entry.

          2. History of cancer or diabetes mellitus

          3. Use of tricyclic antidepressants or anticholinergics

          4. Evidence of active infection or chronic infection including human immunodeficiency
             virus (HIV), tuberculosis (TB), hepatitis C, or a positive hepatitis B surface
             antigen.

          5. Patients with latent TB if not treated with isoniazid for at least 4 weeks prior to
             receiving the study drug

          6. Radiographic evidence of COPD, emphysema, and/or interstitial lung disease.

          7. Subjects who are pregnant or who are nursing infants

          8. Patients with cytopenia: platelet count <80,000/mm3, absolute neutrophil
             count<1500/mm3, hematocrit < 20%.

          9. Patients with renal insufficiency defined by a serum creatinine of greater than or
             equal to 2.0 mg/dL or creatinine clearance of less than or equal to 35 ml/min.

         10. Use of illegal drugs.

         11. A live vaccination fewer than 4 weeks before enrollment
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.


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