Efficacy, Safety and Immunological Evaluation of Tofacitinib in the Treatment of Primary Sjogren's Syndrome

NCT05087589 | Unknown Phase 2 DMC

• 1 other identifier: 20210918pss
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore the clinical and immunological efficacy of tofacitinib on primary Sjögren's Syndrome

Conditions

Primary Sjögren's Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  week 24

Secondary Outcomes (2)

• Improvements in EULAR SS patient-reported index (ESSPRI), other clinical and immunological parameters

  week 24

• Safety and tolerability of tofacitinib as assessed by incidence of adverse events reported and observed

  up tp 24 weeks

Study Arms (1)

tofacitinib

EXPERIMENTAL

Tofacitinib 5mg was taken orally twice a day for 6 months

Drug: Tofacitinib

Interventions

Tofacitinib DRUG

Tofacitinib 5mg was taken orally twice a day for 6 months

tofacitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Department of Rheumatology and Immunology, Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40139690 DERIVED

MeSH Terms

Interventions

tofacitinib

Study Officials

• Zhanguo Li

  Peking University Institute of Rheuamotology and Immunology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qinghong Liu

CONTACT

+86 15774917676; 166618530@qq.com

Jing He

CONTACT

+86 18611707347; hejing1105@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 21, 2021
• Study Start: November 20, 2021
• Primary Completion: January 1, 2023
• Study Completion: October 1, 2023
• Last Updated: March 2, 2022

Record last verified: 2021-10

Locations

CN (1)