Actively Recruiting
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
Led by National Institute of Dental and Craniofacial Research (NIDCR) · Updated on 2026-04-06
60
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years with mild to moderate primary Sjogren's disease
- Participation and enrollment in companion protocol 15-D-0051
- Ability to understand and sign informed consent
- Willingness to comply with all study procedures and availability for study duration
- Good general health based on medical history
- Meets established classification criteria for Sjogren's disease with ESSDAI score between 0 and 13 and stimulated saliva flow greater than 0 ml/min/gland
- Ability and willingness to take oral medication as study treatment
- Stable dose of glucocorticoids less than 10 mg daily for at least 4 weeks prior to screening
- Stable dose of antimalarials (e.g., hydroxychloroquine up to 400 mg/day) for at least 12 weeks prior to screening if applicable
- Stable lipid-lowering medication doses for at least 4 weeks prior to study entry if applicable
- Agree to use effective birth control methods if of reproductive potential
- Agreement to adhere to lifestyle considerations during the study
You will not qualify if you...
- Treatment with rituximab, belimumab, or other biologics within 6 months prior to screening
- Prior use of Tofacitinib for more than 6 months in the last 2 years
- Current treatment with methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, or other specified immunomodulatory drugs unless withdrawn at least 8 weeks before screening
- Treatment with cyclophosphamide, pulse methylprednisolone, or IVIG within 6 months before screening
- Use of potent CYP3A4 inhibitors or combined moderate CYP3A4 and potent CYP2C19 inhibitors within 1 week before study medication
- Chronic liver disease with elevated liver function tests beyond specified limits
- Serum creatinine over 1.5 mg/dL
- Protein to creatinine ratio over 1 mg/dL or confirmed 24-hour urine protein over 1000 mg
- Active urinary sediment with white or red blood cells or casts
- Hypercholesterolemia or hypertriglyceridemia above specified thresholds within 45 days of screening
- Low blood cell counts below defined limits
- Pregnancy or lactation; females must have negative pregnancy test at screening
- History of drug or alcohol abuse within 6 months prior to screening
- Current dialysis treatment
- Active infection requiring antibiotics within 14 days before first dose
- Chronic infections including HIV, Hepatitis B or C, or BK viremia
- Current or previous malignant disease except certain treated skin or cervical cancers
- Known active tuberculosis; treated latent TB allowed with evaluation
- History of severe or systemic infections or infections by unusual pathogens
- Active renal or central nervous system disease or high disease activity in any organ system except joints
- Increased risk factors for major adverse cardiac events including history of ischemic heart disease, heart failure, cardiomyopathy, severe valvular disease, arrhythmias, chronic renal failure, stroke, uncontrolled diabetes or hypertension, or smoking history
- Significant impairment of major organ function or any condition risking safety with Tofacitinib
- History of thrombosis or high clotting risk
- Psychiatric illness or history of non-compliance affecting study completion
- Uncontrolled thyroid disease
- Known allergy to Tofacitinib or its components
- Treatment with another investigational drug within 6 months except authorized COVID-19 therapies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
S
Sasha D Nuby
CONTACT
B
Blake M Warner, D.D.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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