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Tofacitinib for Sjogren's Syndrome
Study Summary
This trial is looking at the safety and tolerability of tofacitinib in adults with Sjogren's syndrome.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 4 trial • 4372 Patients • NCT02092467Trial Design
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Who is running the clinical trial?
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- You are allergic to Tofacitinib or any of its ingredients.I have had infections due to a weakened immune system.I can take pills and will follow the study's treatment plan.I haven't taken rituximab, belimumab, or similar drugs in the last 6 months.I have Sjögren's syndrome with mild to moderate symptoms.I do not have active chronic infections like HIV or Hepatitis.I am not currently on, nor have I taken any immune system modifying drugs in the last 8 weeks.I am not currently on strong CYP3A4 inhibitors or medications that affect Tofacitinib levels.I am between 18 and 75 years old.I have been diagnosed with primary Sjogren's Syndrome with mild to moderate activity.I am using or willing to use effective birth control if I can have children.I have been on a stable dose of hydroxychloroquine or similar drugs for the last 12 weeks.I have had cancer before, but only skin cancer or cervical cancer that was fully treated.I have a history of serious heart or blood vessel problems, kidney failure, uncontrolled diabetes, high blood pressure, or a significant smoking history.I have not used, or have stopped responding to, immune system treatments except for antimalarials and steroids.My thyroid condition is not under control.I have been treated for latent tuberculosis or will be evaluated for eligibility if I have untreated latent TB.I have been on a stable dose of glucocorticoids, less than 10 mg daily, for the last 4 weeks.I do not have active kidney, brain diseases or high disease activity in any organ except joints.I've been on stable cholesterol medication for at least 4 weeks.You have had issues with drugs or alcohol in the past 6 months.I do not have an active infection or have been off antibiotics for at least 14 days.I have not had cyclophosphamide, methylprednisolone, or IVIG treatments in the last 6 months.I am currently on some form of dialysis.I have a history of blood clots or am at high risk for clotting disorders.My major organs are healthy and I have no conditions that would make the study drug unsafe for me.
- Group 1: Placebo group
- Group 2: Subjects with SS
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What prerequisites must a person meet to be eligible for participation in this experiment?
"This clinical trial seeks 30 participants between 18 and 75 that have recalcitrant sicca syndrome. NIH Policy on Inclusion of Women and Minorities as Participants in Research, Involving Human Participants is taken into consideration when selecting patients. Furthermore, individuals must be willing to sign a written informed consent document, participate in the companion protocol 15-D-0051 and comply with all study procedures for the duration of the study. Eligible applicants should also present mild to moderate symptoms (ESSDAI 0 - 13), good overall health based on medical history and ability to take oral medication. Moreover, this sample population can include those who are na"
Does this research program admit geriatric participants?
"Based on the inclusion criteria, this trial is seeking participants aged 18 to 75. However, if you are younger than 18 or older than 65 there are a few hundred trials dedicated to your age group; 380 for those under 18 and 1013 for individuals over 65."
Are there any supplemental investigations regarding tofacitinib?
"Presently, that are 34 extant trials for tofacitinib with 7 at Phase 3. The majority of the tests occur in Shanghai; however, there is a total of 662 research centres conducting studies on this drug."
Are individuals currently able to join this experiment?
"Evidenced on clinicaltrials.gov, this trial is open for recruitment and has been posted since May 18th of 2021 with the latest amendment made October 1st 2022."
To what health concerns is tofacitinib typically prescribed as a remedy?
"Tofacitinib is used to treat juvenile arthritis and other conditions, such as those that are unresponsive or intolerant to methotrexate therapy. Additionally, it has proven beneficial for patients with inadequate responses to conventional treatments."
How many individuals have been accepted into this trial?
"Affirmative. According to the information available on clinicaltrials.gov, this medical investigation is recruiting participants at this very moment. The study was instituted on May 18th 2021 and underwent its most recent edit just two months ago in October 1st 2022. 30 patients are needed from a single location for enrollment in the trial."
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