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Tests treatment safety and results for Sjogren's Syndrome
Official title Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
ClinicalTrials.gov ID: NCT07281456
What this study is testing
What is Tofacitinib?
Tofacitinib is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for sjogren's syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 28 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Adult SjD participants with mild-to-moderate disease activity will be eligible for this study. Enrolled participants can be naive or have failed...
- Ability of participant to understand and the willingness to sign a written informed consent document.
- Participation and enrollment in companion protocol, 15-D-0051, Characterization of Diseases with Salivary Gland Involvement.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged between 18-75 years old
You likely can't join if
- To be eligible to participate in this study, an individual must not meet any of the following criteria:
- Current or prior treatment with rituximab, belimumab, or any other biologic agent in the 6 months prior to screening.
- Current or prior treatment with Tofacitinib for more than 6 months in the last 2 years prior to screening.
- Current treatment with methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, or other less common immunomodulatory drugs such...
- Treatment with cyclophosphamide, pulse methylprednisolone or IVIG within 6 months prior to screening.
- Current treatment with potent inhibitors of Cytochrome P450 3A4 (CYP3A4) (e.g., ketoconazole) or receiving one or more concomitant medications that...
See the full eligibility criteria
Who can join
- Adult SjD participants with mild-to-moderate disease activity will be eligible for this study. Enrolled participants can be naive or have failed immunosuppressive therapy beyond antimalarials and glucocorticoids, to...
- Ability of participant to understand and the willingness to sign a written informed consent document.
- Participation and enrollment in companion protocol, 15-D-0051, Characterization of Diseases with Salivary Gland Involvement.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged between 18-75 years old
- In good general health as evidenced by medical history
- Meets the 2002 American European Consensus Group classification criteria for Sjogren's disease or 2016 American College of Rheumatology/European League against Rheumatism Classification Criteria (ACR-EULAR) with mild to...
- Ability to take oral medication and be willing to adhere to the study intervention regimen
- If on glucocorticoids, the dose must be less than 10 mg daily and stable for the 4 weeks (28 days) prior to the screening visit.
- If on hydroxychloroquine or other antimalarials such as chloroquine or quinacrine, the dose must have been stable for the 12 weeks (96 days) prior to screening visit. The maximum allowed dose is hydroxychloroquine up to...
- Participants may be on lipid lowering medications if initiated at least 3 months prior to the screening visit and dose must be stable for 4 weeks (28 days) prior to study entry.
- Males and females with potential for reproduction must agree to practice effective birth control measures. Females should be on adequate contraception if they are of child-bearing potential documented by a clinician...
- Agreement to adhere to Lifestyle Considerations throughout study duration
What rules you out
- To be eligible to participate in this study, an individual must not meet any of the following criteria:
- Current or prior treatment with rituximab, belimumab, or any other biologic agent in the 6 months prior to screening.
- Current or prior treatment with Tofacitinib for more than 6 months in the last 2 years prior to screening.
- Current treatment with methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, or other less common immunomodulatory drugs such as those falling into the class of disease-modifying antirheumatic...
- Treatment with cyclophosphamide, pulse methylprednisolone or IVIG within 6 months prior to screening.
- Current treatment with potent inhibitors of Cytochrome P450 3A4 (CYP3A4) (e.g., ketoconazole) or receiving one or more concomitant medications that result in both moderate inhibition of CYP3A4 and potent inhibition of...
- History of chronic liver disease, not including well-controlled Sjogren's-related chronic liver disease or elevated LFTs:
- ALT or AST \>= 2x upper limit of normal at screening
- Serum unconjugated bilirubin \> 2mg/dL at screening
- Serum creatinine \>1.5mg/dL.
- Protein to creatinine ratio of more than 1mg/dL at screening (repeated and confirmed three times or confirmed with 24 hours urine protein of more than 1000mg).
- Active urinary sediment (WBC, RBC or mixed cellular casts 1+ or more /hpf).
- Hypercholesterolemia: Values after 8-12 hour fasting blood specimen: total cholesterol \>250 mg/dL or LDL \>180 mg/dL or hypertriglyceridemia (triglyceride \>300 mg/dL) within - 45 days of screening visit.
- WBC \<2500/microL or ANC \<1,000/microL, Hgb \<9.0 g/dL or platelets \<70,000/microL or absolute lymphocyte count \< 500/microL.
- Pregnant or lactating women. Women of childbearing potential are required to have a negative pregnancy test at screening.
- A history of drug or alcohol abuse within the 6 months prior to screening.
- Currently receiving hemodialysis, peritoneal dialysis, or intestinal dialysis.
- Active infection that requires the use of oral or intravenous antibiotics unresolved at least 14 days prior to the administration of the first dose of study medication.
- Active chronic infections including but not limited to HIV, Hepatitis B, Hepatitis C, and BK viremia at screening visit.
- Current or previous diagnosis of malignant disease, except for basal cell or squamous cell carcinoma of the skin with complete excision and clear borders or adequately treated in situ carcinoma of the cervix.
- Known active tuberculosis. Participants with treated latent tuberculosis (LTB) will be eligible to participate. Participants with untreated LTB will not be excluded but will be evaluated by an infectious disease (I.D.)...
- History of severe or systemic infections caused by common pathogens, or history of infection with pathogens that do not normally cause human disease.
- Participants with active renal or central nervous system disease or a high activity level in any organ system (except articular) in ESSDAI54.
- Participants with known increased risk factors for major adverse cardiac event (MACE) including a history of:
- Ischemic heart disease (e.g., history of acute myocardial infarction)
- Heart failure
- Cardiomyopathy
- Severe valvular heart disease
- Significant arrhythmias
- Chronic renal failure
- Cerebrovascular accident or transient ischemic attack
- Uncontrolled diabetes mellitus
- Uncontrolled hypertension
- Current smokers or former smokers with less than 3 years since complete cessation and/or \>20 pack-years of smoking history.
- Significant impairment of major organ function (lung, heart, liver, kidney) or any condition that, in the opinion of the Investigator, would jeopardize the participant's safety following exposure to the Tofacitinib.
- Known history of arterial or venous thrombosis or at high risk for clotting disorder
- Psychiatric illness or history of medical non-compliance that the study team feels will make the patient unlikely to complete the study
- Uncontrolled thyroid disease as determined by PI or medically responsible investigator.
- Known allergic reactions to Tofacitinib or its components
- Treatment with another investigational drug/intervention within six months except for COVID-19 vaccines or therapies that have been granted an FDA emergency authorization.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 28 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.