Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04496960 · ClinicalTrials.gov registry record · Phase 1
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome
A Phase 1 study of Sjogren's Syndrome, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Active
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT04496960 is a Phase 1 study of Sjogren's Syndrome that is active but no longer recruiting, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 23 participants, below the 287-participant average among 20 other Sjogren's Syndrome trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04496960, a Phase 1 study of Sjogren's Syndrome, is active but no longer recruiting, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG tofacitinib
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2021-05-18 |
| Est. Completion | 2026-09-22 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04496960
The ClinicalTrials.gov registry entry for NCT04496960 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 287-participant average among 20 other Sjogren's Syndrome trials with a reported enrollment target (92% lower). The listed sponsor is National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Sjogren's Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04496960 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT04496960 about?
NCT04496960 is a clinical study titled "Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome". 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: T...
What is the current status of trial NCT04496960?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2021-05-18. Estimated completion is 2026-09-22.
What conditions does trial NCT04496960 study?
This clinical trial studies the following conditions: Sjogren's Syndrome.
What interventions are being tested in trial NCT04496960?
The interventions under investigation include: Placebo (OTHER), tofacitinib (DRUG).
Who is sponsoring clinical trial NCT04496960?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04496960 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sjogren's Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease
RECRUITING · Phase 1
-
Anti-CD20 Antibody Therapy for Sjogren's Syndrome
COMPLETED · Phase 1
-
An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness
COMPLETED · Phase 1
-
Omalizumab for Lupus
COMPLETED · Phase 1
-
Rheumatology Diet Study
RECRUITING
-
Creating Health Course Study for People With Rheumatological Conditions
RECRUITING · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.