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Janus Kinase Inhibitor

Tofacitinib for Sjogren's Syndrome

Phase 1 & 2
Recruiting
Led By Blake M Warner, D.D.S.
Research Sponsored by National Institute of Dental and Craniofacial Research (NIDCR)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, aged between 18-75 years
Meets the 2002 American European Consensus Group classification criteria for primary Sjogren's Syndrome with mild to moderate disease activity defined as ESSDAI between 0 to 13 at the screening visit and >0 ml/min/gland stimulated saliva flow
Must not have
History of opportunistic infections
Current or prior treatment with rituximab, belimumab or any other biologic agent in the 6 months prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24

Summary

This trial is looking at the safety and tolerability of tofacitinib in adults with Sjogren's syndrome.

Who is the study for?
Adults aged 18-75 with Primary Sjogren's Syndrome (SS) who have mild-to-moderate disease activity. Participants can be new to treatment or may have tried some immunosuppressive therapies, but not certain strong medications. They must be in good health overall and agree to use effective birth control if applicable.
What is being tested?
The trial is testing the safety and tolerance of Tofacitinib, an oral medication, compared to a placebo over a period of 168 days. It includes various tests like heart exams, eye exams, saliva collection, blood pressure monitoring, and questionnaires about health during nine study visits over 28 weeks.
What are the potential side effects?
Potential side effects of Tofacitinib could include infections due to immune system suppression, liver enzyme changes leading to liver damage, increased cholesterol levels which might affect heart health, digestive issues such as nausea or diarrhea and possibly headaches or respiratory infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I have been diagnosed with primary Sjogren's Syndrome with mild to moderate activity.
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I have been on a stable dose of hydroxychloroquine or similar drugs for the last 12 weeks.
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I have been on a stable dose of glucocorticoids, less than 10 mg daily, for the last 4 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had infections due to a weakened immune system.
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I haven't taken rituximab, belimumab, or similar drugs in the last 6 months.
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I do not have active chronic infections like HIV or Hepatitis.
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I am not currently on, nor have I taken any immune system modifying drugs in the last 8 weeks.
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I have a history of serious heart or blood vessel problems, kidney failure, uncontrolled diabetes, high blood pressure, or a significant smoking history.
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My thyroid condition is not under control.
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I do not have active kidney, brain diseases or high disease activity in any organ except joints.
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I have not had cyclophosphamide, methylprednisolone, or IVIG treatments in the last 6 months.
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I am currently on some form of dialysis.
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I have a history of blood clots or am at high risk for clotting disorders.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
safety and tolerability of tofacitinib
Secondary study objectives
ESSDAI
changes in salivary flow rates

Side effects data

From 2020 Phase 4 trial • 4372 Patients • NCT02092467
22%
Upper respiratory tract infection
15%
Bronchitis
13%
Rheumatoid arthritis
13%
Urinary tract infection
12%
Nasopharyngitis
12%
Fall
12%
Herpes zoster
9%
Hypertension
8%
Arthralgia
7%
Diarrhoea
7%
Lymphopenia
7%
Sinusitis
7%
Back pain
6%
Osteoarthritis
6%
Influenza
6%
Latent tuberculosis
6%
Pharyngitis
5%
Nausea
5%
Anaemia
5%
Alanine aminotransferase increased
5%
Cough
4%
Gastroenteritis
3%
Pneumonia
3%
Headache
1%
Coronary artery disease
1%
Femur fracture
1%
Cellulitis
1%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tofacitinib 5 mg BID
Tofacitinib 10 mg BID
TNFi

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Subjects with SSExperimental Treatment1 Intervention
Receiving tofacidinib
Group II: Placebo groupPlacebo Group1 Intervention
Receiving placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tofacitinib
2012
Completed Phase 4
~5620

Find a Location

Who is running the clinical trial?

National Institute of Dental and Craniofacial Research (NIDCR)Lead Sponsor
306 Previous Clinical Trials
849,994 Total Patients Enrolled
13 Trials studying Sjogren's Syndrome
4,194 Patients Enrolled for Sjogren's Syndrome
Blake M Warner, D.D.S.Principal InvestigatorNational Institute of Dental and Craniofacial Research (NIDCR)
5 Previous Clinical Trials
1,795 Total Patients Enrolled
2 Trials studying Sjogren's Syndrome
1,550 Patients Enrolled for Sjogren's Syndrome

Media Library

Tofacitinib (Janus Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04496960 — Phase 1 & 2
Sjogren's Syndrome Research Study Groups: Placebo group, Subjects with SS
Sjogren's Syndrome Clinical Trial 2023: Tofacitinib Highlights & Side Effects. Trial Name: NCT04496960 — Phase 1 & 2
Tofacitinib (Janus Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04496960 — Phase 1 & 2
~15 spots leftby Sep 2025
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