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Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fields
  2. Primary endpoints: details revised at 1 of 2 entries
    • Eligibility criteria expanded, about 52 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Study description expanded, about 6 words
  3. 7 versions Re-verified since Mar 27, 2026, no change to tracked fieldsv8-v14
  4. Secondary endpoints revised (5)v7
  5. Eligibility criteria revisedv6
Show 4 earlier versionsHide 4 earlier versions
  1. Re-verified, no change to tracked fieldsv5
  2. Eligibility criteria expanded, about 3 wordsv4
  3. Eligibility criteria shortened, about 1 wordv3
  4. Start date changed from estimate of Jan 15, 2026 to Dec 18, 2025v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: Sjogren disease is an autoimmune disease - that is, a disease that causes the body's immune system to attack its own organs and tissues. Sjogren disease can affect the kidneys, lungs, or other organs. It can also cause dry mouth and eyes, fever, joint pain, rashes, and other symptoms. Researchers want to know if a drug approved to treat rheumatoid arthritis and other autoimmune diseases can help people with Sjogren disease. Objective: To test a drug (tofacitinib) in people with Sjogren disease. Eligibility: People aged 18 to 75 years with Sjogren disease. They must be enrolled in protocol 15-D-0051. Design: * Participants will be screened. They will have a physical exam with blood and urine tests. They will give samples of saliva; a small sample of tissue will be taken from a salivary gland. They will have a test of their heart function. They will have an eye exam, including a test for dry eyes. * Tofacitinib is a tablet taken by mouth. Participants will take the drug twice a day at home. * Participants will have 9 clinic visits over 28 weeks. Each visit will take up to 5 hours. In addition to repeated tests, they will have tests of the speed and pressure of blood flow through their body. They will complete health questionnaires throughout the study. * Participants will also have 5 phone visits during the study. They will review their health and study treatments. * They will have 1 final visit after they stop taking the drug.
Trial Details
NCT Number NCT07281456
Lead Sponsor National Institute of Dental and Craniofacial Research (NIDCR)
Conditions
(from sponsor)		 Sjogren's Syndrome
Related terms Inflammation, Sjogren's Syndrome, Xerophthalmia, Xerostomia
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov