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Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 316 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Notable Results first posted: Dec 18, 2025v316
  2. Minor Secondary endpoints: details revised at 1 of 5 entriesv315
  3. Notable Primary endpoints: 1 to 2
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: 2 to 5
    v314
  4. Minor Trial status: Recruiting to Active, Not Recruitingv313 Show 4 more changesShow less
    • Enrollment target: estimated 76 to confirmed 23
    • Primary completion date changed from estimate of Sep 21, 2025 to Jan 14, 2025
    • Study completion date: Sep 22, 2025 to Sep 22, 2026
    • Site details revised
  5. Minor 4 versions Re-verified since Jul 27, 2024, no change to tracked fieldsv309-v312
Show 42 earlier versionsHide 42 earlier versions
  1. Minor Eligibility criteria expanded, about 19 wordsv308
  2. Minor 7 versions Re-verified since Mar 13, 2024, no change to tracked fieldsv301-v307
  3. Minor Eligibility criteria shortened, about 3 wordsv300
  4. Minor 5 versions Re-verified since Jun 27, 2023, no change to tracked fieldsv295-v299
  5. Minor Eligibility criteria expanded, about 12 wordsv294
  6. Minor Eligibility criteria revised
    • Study description revised
    v293
  7. Notable Enrollment target: 30 to 76v292
  8. Notable Primary completion date: Sep 21, 2023 to Sep 21, 2025
    • Study completion date: Sep 20, 2024 to Sep 22, 2025
    v291
  9. Minor 8 versions Re-verified since Sep 29, 2022, no change to tracked fieldsv283-v290
  10. Minor Study Status, Eligibilityv282
  11. Minor Eligibility criteria shortened, about 9 wordsv281
  12. Minor 7 versions Re-verified since Jun 24, 2022, no change to tracked fieldsv274-v280
  13. Minor Eligibility criteria expanded, about 59 wordsv273
  14. Minor 6 versions Re-verified since Jun 13, 2022, no change to tracked fieldsv267-v272
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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: An autoimmune disease is one in which the immune system attacks a person's own body. Sjogren's syndrome (SS) is an autoimmune disease. It often involves multiple systems and organs of the body. Researchers are trying to find new, more effective and safe treatments for SS. Objective: To evaluate the safety and tolerance of tofacitinib in people with SS. Eligibility: Adults ages 18-75 with SS. Design: Participants will be screened on a separate protocol. They will undergo: * Medical and dental history * Physical exam * Medicine review * Electrocardiogram to test the heart s electrical activity (Participants will lay on a table. Sticky pads will be placed on their body.) * Eye exam and test for dry eyes * Oral, head, and neck exams * Plaque collection (Dental plaques and tongue and mucosal scrapings will be collected using a small tongue depressor.) * Salivary gland ultrasound * Blood and urine tests * Minor salivary gland biopsy (The lower lip will be numbed. Several tiny salivary glands will be removed through a small incision.) * Saliva collection * Disease assessment. Participants will repeat some of the screening tests during the study. Participants will take capsules of the study drug or a placebo by mouth for 168 days. Participants will have tests to measure blood pressure and the speed of blood flow through the organs. They will also have a test that examines the function and reaction of the blood vessels. For these tests, they will wear blood pressure cuffs and other sensors. Participants will complete questionnaires about their health. Participants will have 9 study visits over 28 weeks. They may be contacted by phone between study visits.
Trial Details
NCT Number NCT04496960
Lead Sponsor National Institute of Dental and Craniofacial Research (NIDCR)
Conditions
(from sponsor)
Sjogren's Syndrome
Related terms Inflammation, Sjogren's Syndrome, Xerostomia
Enrollment 23 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov