RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Tofacitinib for Sjogren's Syndrome

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.

Official registry: https://clinicaltrials.gov/study/NCT07281456 · National Institute of Dental and Craniofacial Research (NIDCR) · enrollment listed as 60

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Tofacitinib. The registry lists allocation as na. 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.

They plan to enroll about 60 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Disease Phase IIa Open-Label Clinical Trial and Associated Mechanistic Studies

Interventions: Tofacitinib

Primary outcome (registry wording): Number of Adverse Events by Grade/Category

Who it is for (from inclusion criteria)

Ages 18 Years to 75 Years
To be eligible to participate in this study, an individual must meet all of the following criteria:
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
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

Who the registry excludes

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
Treatment with cyclophosphamide, pulse methylprednisolone or IVIG within 6 months prior to screening
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

Public study contact (from the registry)

Sasha D Nuby

(301) 529-7924

sasha.clary@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

National Institutes of Health Clinical Center — Bethesda, Maryland (recruiting)

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseBethesda, Maryland

Von Hippel-Lindau (VHL): Clinical Manifestations, Diagnosis, Management and Molecular Bases of Inherited Re…

We will investigate the clinical manifestations and molecular genetic defects of heritable urologic malignant disorders. Families with urologic malignancy with known or suspected genetic basis will be enrolled.

NCT00001238 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

RecruitingNot a traditional drug phaseBethesda, Maryland

Study of Systemic Lupus Erythematosus

This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE.

NCT00001372 · Official ClinicalTrials.gov record · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

RecruitingNot a traditional drug phaseWashington D.C., District of Columbia

Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics

This study is designed to explore the genetics and pathophysiology of diseases presenting with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases. The following individuals may be eligible for this natural history study: 1) patients with known or suspected familial Mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of these patients; 3) healthy, normal volunteers 7 years of age or older.

NCT00001373 · Official ClinicalTrials.gov record · National Human Genome Research Institute (NHGRI)

FAQ about this NCT record

Is NCT07281456 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07281456?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07281456?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary