Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome
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|ClinicalTrials.gov Identifier: NCT04496960|
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : April 19, 2021
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.
To evaluate the safety and tolerance of tofacitinib in people with SS.
Adults ages 18-75 with SS.
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.
|Condition or disease||Intervention/treatment||Phase|
|Sjogren's Syndrome||Drug: tofacitinib Other: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome; A Phase Ib-IIa Placebo-Controlled Clinical Trial and Associated Mechanistic Studies|
|Estimated Study Start Date :||April 22, 2021|
|Estimated Primary Completion Date :||February 6, 2023|
|Estimated Study Completion Date :||February 5, 2024|
Placebo Comparator: Placebo group
white, round, film-coated tablet
Experimental: Subjects with SS
XELJANZ(R) is the citrate salt of tofacitinib. Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d] pyrimidin-4-ylamino) -beta-oxo-1-piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1) It is freely soluble in water and has a molecular weight of 504.5 Daltons. XELJANZ(R) is supplied for oral administration as 5 mg tofacitinib (equivalent to 8 mg tofacitinib citrate) white round, immediate-release film-coated tablet. Each tablet of XELJANZ(R) contains the appropriate amount of XELJANZ(R) as a citrate salt and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, HPMC 2910 /Hypromellose 6cP, titanium dioxide, macrogol/PEG3350, and triacetin.
- safety and tolerability of tofacitinib [ Time Frame: week 24 (end of Treatment) ]To determine the safety and tolerability of tofacitinib in subjects with SS and mild to moderate disease activity.
- changes in salivary flow rates [ Time Frame: week 24 ]salivary flow rates are an objective measure of organ function. Low salivary flow is a primary feature of SS and may be used as a noninvasive measure of therapeutic intervention. Studying the effects of tofacitinib versus placebo via randomized trial provides the best opportunity to show causality and association.
- ESSDAI [ Time Frame: Week 24 ]The ESSDAI was developed to be used as an outcome measure in clinical trials involving Sjogren's Syndrome patient cohorts and allows for assessment/scoring of major domain activity relevant to a SS population.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04496960
|Contact: Getriz R Martinemail@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Blake M Warner, D.D.S.||National Institute of Dental and Craniofacial Research (NIDCR)|