Is NCT07281456 recruiting in Bethesda, MD?

Yes, NCT07281456 is currently recruiting participants at its Bethesda, MD location. This sjogren's syndrome clinical trial is actively enrolling qualified participants.

How do I join the sjogren's syndrome clinical trial in Bethesda?

To join this clinical trial in Bethesda, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Bethesda clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Sjogren's Syndrome Clinical Trial in Bethesda, MD

About This Sjogren's Syndrome Study in Bethesda

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.

Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)

Who Can Participate

Inclusion Criteria

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 prevent bias in the cohort of participants with more recalcitrant disease. We expect that Tofacitinib is a potential second-line therapy, in addition to antimalarials and glucocorticoids, depending on the participant's initial presentation and response. Women and members of minority groups, if eligible, will be included in accordance with the NIH Policy on Inclusion of Women and Minorities as Participants in Research Involving Human Participants. Additionally, 20-D-0131(Safety of Tofacitinib, an oral Janus Kinase Inhibitor, in primary Sjogren's syndrome Phase Ib-IIa placebo-controlled clinical trial and associated mechanistic studies) participants who, at unblinding, received a placebo will be contacted and asked to return to the study to participate in this study. To be eligible to participate in this study, an individual must meet all of the following criteria:

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 moderate disease activity defined as ESSDAI between 0 and 13 at the screening visit and \>0 ml/min/gland stimulated saliva flow.

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 400 mg/day or 6.5 mg/kg/day if more than 400 mg/day. The maximum allowed dose for chloroquine phosphate is up to 500 mg daily and for quinacrine up to 100 mg daily.

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, unless participants or spouse have previously undergone a sterilization procedure. Adequate birth control measures are: intrauterine device (IUD) alone or hormone implants, hormone patches, injectable, or oral contraceptives plus a barrier method (male condom, female condom or diaphragm), abstinence or a vasectomized partner.

Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion Criteria

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 drugs (DMARDs), not otherwise specified herein. Participants previously on methotrexate, azathioprine, mycophenolate mofetil, cyclosporine or tacrolimus, or other DMARDs should have withdrawn drug for at least 8 weeks (56 days) at the time of screening. The use of topical or ophthalmic preparations of cyclosporine, tacrolimus, or other DMARDs is permitted and does not require an 8-week withdrawal period.

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 CYP2C19 (e.g., fluconazole) that would increase serum availability of Tofacitinib. Past treatment with the agent is allowed if it was more than a week prior to the administration of the first dose of study medication.

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.) consultant and may become eligible for trial based on infectious disease consultant recommendations.

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT07281456) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Sjogren's Syndrome Treatment Options in Bethesda, MD

If you're searching for sjogren's syndrome treatment options in Bethesda, MD, this clinical trial (NCT07281456) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced sjogren's syndrome specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all sjogren's syndrome clinical trials near you to find additional studies recruiting in your area.

Sjogren's Syndrome Clinical Trial in Bethesda, MD

Expert Care in Bethesda

IRB Approved

No-Cost Care

Apply for This Bethesda Location

Why Participate?

Simple Process