Ignite Creation Date:
2024-05-06 @ 3:01 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04496960
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2020-08-02
Brief Title:
Safety of Tofacitinib an Oral Janus Kinase Inhibitor in Primary Sjogrens Syndrome
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Safety of Tofacitinib an Oral Janus Kinase Inhibitor in Primary Sjogrens Syndrome a Phase Ib-IIa Placebo-controlled Clinical Trial and Associated Mechanistic Studies
Status:
RECRUITING
Status Verified Date:
2024-07-25
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
An autoimmune disease is one in which the immune system attacks a person s own body Sjogrens 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
An autoimmune disease is one in which the immune system attacks a person s own body Sjogrens 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
Detailed Description:
Study Description
As a primary objective this study represents an innovative investigative measure of the safety and tolerability of JAK inhibition in participants with primary Sjogrens syndrome Secondary objectives will include investigating the effects of Tofacitinib on target tissues eg salivary glands systemic inflammation and on vascular function in SS participants We also aim to identify biomarkers of response that may be useful as endpoints in future studies
Objectives
Primary Objective
-To determine the safety and tolerability of Tofacitinib in participants with SS and mild to moderate disease activity
Secondary Objectives
To assess clinical improvement after treatment with Tofacitinib as measured by changes in the European League Against Rheumatism EULAR Sjogrens syndrome Disease Activity Index ESSDAI and no worsening on the Physician s Global assessment Scale PGA
To demonstrate that treatment with Tofacitinib is effective clinically and biologically in SS individuals with mild to moderate disease
To investigate the effects of Tofacitinib on systemic biomarkers of SS as measures biological effects that can be used as outcome measures to power a larger Clinical Trial
Endpoints
Primary Endpoint
-Safety and tolerability will be measured by assessment of adverse events AEs and clinical safety laboratory tests throughout the study Toxicity is defined as any study drug-related Grade 3 adverse event or higher as measured by the National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE Version 50
Secondary Endpoints
Preliminary assessments of clinical response will be measured by
Changes in the ESSDAI score between Baseline and Day 168 end of treatment
Changes in the Physicians Global Assessment PGA scores between baseline and study day 168
As a primary objective this study represents an innovative investigative measure of the safety and tolerability of JAK inhibition in participants with primary Sjogrens syndrome Secondary objectives will include investigating the effects of Tofacitinib on target tissues eg salivary glands systemic inflammation and on vascular function in SS participants We also aim to identify biomarkers of response that may be useful as endpoints in future studies
Objectives
Primary Objective
-To determine the safety and tolerability of Tofacitinib in participants with SS and mild to moderate disease activity
Secondary Objectives
To assess clinical improvement after treatment with Tofacitinib as measured by changes in the European League Against Rheumatism EULAR Sjogrens syndrome Disease Activity Index ESSDAI and no worsening on the Physician s Global assessment Scale PGA
To demonstrate that treatment with Tofacitinib is effective clinically and biologically in SS individuals with mild to moderate disease
To investigate the effects of Tofacitinib on systemic biomarkers of SS as measures biological effects that can be used as outcome measures to power a larger Clinical Trial
Endpoints
Primary Endpoint
-Safety and tolerability will be measured by assessment of adverse events AEs and clinical safety laboratory tests throughout the study Toxicity is defined as any study drug-related Grade 3 adverse event or higher as measured by the National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE Version 50
Secondary Endpoints
Preliminary assessments of clinical response will be measured by
Changes in the ESSDAI score between Baseline and Day 168 end of treatment
Changes in the Physicians Global Assessment PGA scores between baseline and study day 168
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20-D-0131 | None | None | None |