Primary Sjögren's SyndromePhase 2NCT05087589
Efficacy, Safety and Immunological Evaluation of Tofacitinib in the Treatment of Primary Sjogren's Syndrome
A Phase 2 study testing Tofacitinib in people with Primary Sjögren's Syndrome, run by Peking University People's Hospital at 1 site in China.
Trial summary
This study aims to explore the clinical and immunological efficacy of tofacitinib on primary Sjögren's Syndrome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Sjögren's Syndrome
- What is being tested?
- Tofacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2021to 1 Oct 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female >18 years of age at screening visits
- Patients meet the American-European Consensus Group 2002 classification criteria
- The patient must be informed in writing of the consent to participate in the trial and the patient is expected to be able to comply with the requirements of the study follow-up plan and other protocols.
- Dosing of antimalarials, prednisone or equivalent, cholinergic stimulants, and topical cyclosporine required to be stable for at least 4 weeks before screening and during study; maximum doses allowed:
- Hydroxychloroquinone, 400 mg/day;
- Prednisone, 10 mg/day
Who cannot join
- Any subject meeting any of the following criteria should be excluded:
- Laboratory abnormality:
- Hb≤9 g/dl
- Neutrophil <1.0 x 109/l
- lymphocyte<0.5 x 109/l
- Diagnosis of other autoimmune disease, or other sicca syndrome.
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- Use rituximab or other monoclonal antibodies within 6 months.
- Received high doses of glucocorticoid (>10 mg/d) within 1 month.
- Serious complications: including heart failure (≥ New York Heart Association (NYHA) class III), renal insufficiency (creatinine clearance ≤ 30 ml/min), liver dysfunction (serum Alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than three times the upper limit of normal, or total bilirubin greater than Normal upper limit)
- Known allergies, hyperreactivity or intolerance of tofacitinib or its excipients.
- Have a serious infection needing hospitalization (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, EB virus, tuberculosis infection), or use intravenous antibiotics to treat infection in 2 months before the enrollment.
- Infection with HIV (HIV antibody positive serology) or hepatitis C (Hep C antibody positive serology). If seropositive, it is recommended to consult a doctor who has expertise in treating HIV or hepatitis C virus infection.
- Any known history of malignancy in the past 5 years (except for non-melanoma skin cancer, non-melanoma skin cancer or cervical tumor without recurrence within 3 months after surgical cure prior to the first study preparation).
- Uncontrolled mental or emotional disorders, including a history of drug and alcohol abuse over the past 3 years, may hinder the successful completion of the study.
- Pregnant, lactating women (WCBP) are reluctant to use medically approved contraceptives during treatment and 12 months after treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Jing He, MD and PhD, +8618611707347, hejing1105@gmail.com
About this study
Official title: Efficacy, Safety and Immunological Evaluation of Tofacitinib in the Treatment of Primary Sjögren's Syndrome:a Prospective Observational Study
This study aims to explore the clinical and immunological efficacy of tofacitinib on primary Sjögren's Syndrome
Read the detailed description
The investigators designed a single center, open-label, prospective study. Adults with active primary Sjögren's Syndrome will be enrolled, meeting the American College of Rheumatology(ACR) \& European allance of associations for rheumatology(EULAR)(2016) diagnostic criteria . Tofacitinib 5 mg bd was administered for 6 months to explore its efficacy and safety. The improvement of clinical and laboratory indexes was evaluated. Changes of immune cell subsets and cytokines were monitored.
- Conditions
- Primary Sjögren's Syndrome
- Being tested
- Tofacitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TofacitinibDrug
Tofacitinib 5mg was taken orally twice a day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| tofacitinib | Experimental | Tofacitinib 5mg was taken orally twice a day for 6 months Receives: Drug: Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological Responses
Analysis interleukin 17 (IL-17)-producing helper T (Th17) cells before and during tofacitinib treatment. P values below 0.05 are considered statistically significant in this study.
Measured: week 24
Secondary outcomes (2)
Improvements in EULAR SS patient-reported index (ESSPRI), other clinical and immunological parameters
ESSPRI ranges from 0 to 10. The patient's acceptability/satisfaction of its current state (taking account of his symptoms: dryness, fatigue and pain) should be recorded. For addressing patient-reported outcomes, we define response as an improvement of ESSPRI at least one point or 15% .
Measured: week 24
Safety and tolerability of tofacitinib as assessed by incidence of adverse events reported and observed
we will report frequency of adverse events.Adverse events includes infection, tumor, abnormal neutrophil and lymphocyte count, anemia,drug-induced liver and kidney damage.
Measured: up tp 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start20 Nov 2021
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Sjögren's SyndromeStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhanguo Li, Principal investigator, Peking University Institute of Rheuamotology and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087589
- Sponsor's protocol ID
- 20210918pss
- Status last verified
- Oct 2021
- First submitted
- 8 Oct 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu Q, Zeng Y, Xing X, Huang B, Feng R, Wang Y, Wang N, Zhang X, Li Y, Su L, Jacob A, Ambrus JL Jr, Shen L, Suresh L, Yu D, Lin X, He J. Evaluating the therapeutic potential of tofacitinib in Sjogren's disease: a comprehensive clinical and immunological assessment. Rheumatology (Oxford). 2025 Nov 1;64(11):5899-5910. doi: 10.1093/rheumatology/keaf173.
PubMed 40139690
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Immunological Evaluation of Tofacitinib in the Treatment of Primary Sjögren's Syndrome:a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05087589
- Acronym / sponsor ID
- 20210918pss
- Conditions
- Primary Sjögren's Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to explore the clinical and immunological efficacy of tofacitinib on primary Sjögren's Syndrome
Detailed description
The investigators designed a single center, open-label, prospective study. Adults with active primary Sjögren's Syndrome will be enrolled, meeting the American College of Rheumatology(ACR) \& European allance of associations for rheumatology(EULAR)(2016) diagnostic criteria . Tofacitinib 5 mg bd was administered for 6 months to explore its efficacy and safety. The improvement of clinical and laboratory indexes was evaluated. Changes of immune cell subsets and cytokines were monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tofacitinib | Experimental | Drug: TofacitinibTofacitinib 5mg was taken orally twice a day for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female >18 years of age at screening visits
- Patients meet the American-European Consensus Group 2002 classification criteria
- The patient must be informed in writing of the consent to participate in the trial and the patient is expected to be able to comply with the requirements of the study follow-up plan and other protocols.
- Dosing of antimalarials, prednisone or equivalent, cholinergic stimulants, and topical cyclosporine required to be stable for at least 4 weeks before screening and during study; maximum doses allowed:
Key exclusion criteria (15 listed)
- Laboratory abnormality:
- Diagnosis of other autoimmune disease, or other sicca syndrome.
- Use rituximab or other monoclonal antibodies within 6 months.
- Received high doses of glucocorticoid (>10 mg/d) within 1 month.
- Serious complications: including heart failure (≥ New York Heart Association (NYHA) class III), renal insufficiency (creatinine clearance ≤ 30 ml/min), liver dysfunction (serum Alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than three times the upper limit of normal, or total bilirubin greater than Normal upper limit)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TofacitinibTofacitinib 5mg was taken orally twice a day for 6 months | Drug | tofacitinib |
Primary outcome
Immunological Responses
Time frame: week 24
Analysis interleukin 17 (IL-17)-producing helper T (Th17) cells before and during tofacitinib treatment. P values below 0.05 are considered statistically significant in this study.
2 secondary outcomes
Improvements in EULAR SS patient-reported index (ESSPRI), other clinical and immunological parameters
Time frame: week 24
Safety and tolerability of tofacitinib as assessed by incidence of adverse events reported and observed
Time frame: up tp 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Derived from this study: PubMed 40139690Liu Q, Zeng Y, Xing X, Huang B, Feng R, Wang Y, Wang N, Zhang X, Li Y, Su L, Jacob A, Ambrus JL Jr, Shen L, Suresh L, Yu D, Lin X, He J. Evaluating the therapeutic potential of tofacitinib in Sjogren's disease: a comprehensive clinical and immunological assessment. Rheumatology (Oxford). 2025 Nov 1;64(11):5899-5910. doi: 10.1093/rheumatology/keaf173.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhanguo Li principal investigator
Peking University Institute of Rheuamotology and Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tofacitinib in people with Primary Sjögren's Syndrome, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qinghong Liu (+86 15774917676, 166618530@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunological Responses (time frame: week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05087589, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.