Tofacitinib for Sjogren's Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests tofacitinib, a medication typically used for rheumatoid arthritis, to determine its effectiveness for Sjogren's syndrome, an autoimmune disease that often causes dry mouth, dry eyes, and other symptoms. The study aims to assess whether this drug can improve symptoms in those with mild to moderate disease activity. Individuals with Sjogren's syndrome who have not tried or not succeeded with certain treatments might be suitable for this trial. Participants will take the medication at home and attend several clinic visits to monitor changes. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
You may need to stop certain medications to join the trial. If you are currently taking methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, or other similar drugs, you must stop them at least 8 weeks before the trial. However, you can continue taking glucocorticoids and antimalarials if the doses are stable for a specified period before the trial.
Is there any evidence suggesting that tofacitinib is likely to be safe for humans?
Research has shown that tofacitinib, a drug already used for rheumatoid arthritis, may help with Sjogren's disease. Studies suggest that tofacitinib can ease symptoms and help control the immune system in people with Sjogren's. Regarding safety, tofacitinib is generally well-tolerated. Research on its use in other conditions, like juvenile arthritis, found it to be safe over long periods.
Participants in earlier studies mostly reported mild to moderate side effects, such as headaches or stomach upset. While more research is needed, current evidence suggests that tofacitinib could be a safe option for those with Sjogren's disease.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for Sjogren's Syndrome, which often include medications like hydroxychloroquine or methotrexate that primarily target inflammation, tofacitinib works by inhibiting the Janus kinase (JAK) pathway. This pathway is crucial in the process of inflammation and immune response. Researchers are excited about tofacitinib because it offers a new way to reduce symptoms by directly targeting and modulating the immune system. This mechanism could potentially lead to more effective management of the disease with possibly fewer side effects than current options.
What evidence suggests that tofacitinib might be an effective treatment for Sjogren's Syndrome?
Research has shown that tofacitinib, a medication already used for rheumatoid arthritis, may help treat Sjogren's syndrome. In one study with 112 patients, many experienced significant improvements in their condition, as measured by a tool that tracks disease activity. After six months, 90% of the patients showed noticeable improvement in their symptoms, including a reduction in inflammation of 20% or more. This trial will evaluate tofacitinib for Sjogren's syndrome, and these results suggest that tofacitinib could effectively reduce symptoms of the condition.12367
Who Is on the Research Team?
Blake M Warner, D.D.S.
Principal Investigator
National Institute of Dental and Craniofacial Research (NIDCR)
Are You a Good Fit for This Trial?
This trial is for people aged 18 to 75 with Sjogren's disease, which causes dry mouth and eyes among other symptoms. Participants must be enrolled in another specific study (protocol 15-D-0051) and are willing to undergo various tests including physical exams, blood and urine tests, saliva samples, tissue biopsies from a salivary gland, heart function tests, eye exams, and complete health questionnaires.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tofacitinib 5 mg orally twice daily for 168 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tofacitinib
Trial Overview
The trial is testing Tofacitinib - an oral medication already used for rheumatoid arthritis - to see if it can help with Sjogren's disease. Participants will take the drug twice daily at home and attend nine clinic visits over 28 weeks plus five phone check-ins. They'll have repeated medical tests throughout the study.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Sjogren's Disease (SjD) patients with mild to moderate disease activity receive tofacitinib 5 mg orally twice daily for 168 days.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Dental and Craniofacial Research (NIDCR)
Lead Sponsor
Citations
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in ...
Sjogren's Disease (SjD) patients with mild to moderate disease activity receive tofacitinib 5 mg orally twice daily for 168 days. XELJANZ(R) is ...
Therapeutic Potential of Tofacitinib in Sjögren's Disease
Results: In cohort ǀ, 112 patients treated with tofacitinib showed a significant improvement in the ESSDAI score (median [IQR], 8.00 (4.25, ...
3.
academic.oup.com
academic.oup.com/rheumatology/advance-article/doi/10.1093/rheumatology/keaf173/8096387Evaluating the therapeutic potential of tofacitinib in Sjögren's ...
In cohort ǀ, 112 patients treated with tofacitinib showed a significant improvement in the ESSDAI score (median [IQR], 8.00 (4.25, 15.75) vs ...
4.
acrabstracts.org
acrabstracts.org/abstract/efficacy-of-tofacitinib-immunotherapy-suppresses-tfh-and-tph-cells-in-patients-with-primary-sjogrens-syndrome/Efficacy of Tofacitinib Immunotherapy Suppresses Tfh and ...
After 6 months of treatment, 90% patients achieved MCII of ESSDAI (B) and 80% patients achieved MCII of ESSPRI (D). ESSPRI, EULAR primary SS Patient Reported ...
Novel therapies in Sjögren’s disease: Systematic review
Responders to each therapeutic were defined as patients who experienced ≥20 % improvement in C reactive protein (CRP) levels and ≥20 % improvement in a ...
Safety and efficacy of tofacitinib for the treatment of patients ...
We report the safety, tolerability and efficacy of tofacitinib in patients with juvenile idiopathic arthritis (JIA) in an ongoing long-term extension (LTE) ...
Volunteers Needed for Sjögren's Syndrome Study
For every two patients who receive tofacitinib, one will receive placebo; in total 20 subjects will receive drug, and 10 will receive placebo.
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