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

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ClinicalTrials.gov Identifier: NCT05087589
Recruitment Status : Recruiting
First Posted : October 21, 2021
Last Update Posted : November 16, 2021
Sponsor:
Information provided by (Responsible Party):
Peking University People's Hospital

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

Condition or disease Intervention/treatment Phase
Primary Sjögren's Syndrome Drug: Tofacitinib Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy, Safety and Immunological Evaluation of Tofacitinib in the Treatment of Primary Sjögren's Syndrome:a Prospective Observational Study
Estimated Study Start Date : November 18, 2021
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: tofacitinib
Tofacitinib 5mg was taken orally twice a day for 6 months
Drug: Tofacitinib
Tofacitinib 5mg was taken orally twice a day for 6 months




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Improvements in EULAR SS patient-reported index (ESSPRI), other clinical and immunological parameters [ Time Frame: week 24 ]
    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% .

  2. Safety and tolerability of tofacitinib as assessed by incidence of adverse events reported and observed [ Time Frame: up tp 24 weeks ]
    we will report frequency of adverse events.Adverse events includes infection, tumor, abnormal neutrophil and lymphocyte count, anemia,drug-induced liver and kidney damage.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female >18 years of age at screening visits
  2. Patients meet the American-European Consensus Group 2002 classification criteria
  3. 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.
  4. 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

Exclusion Criteria:

Any subject meeting any of the following criteria should be excluded:

  1. Laboratory abnormality:

    • Hb≤9 g/dl
    • Neutrophil <1.0 x 109/l
    • lymphocyte<0.5 x 109/l
  2. Diagnosis of other autoimmune disease, or other sicca syndrome.
  3. Use rituximab or other monoclonal antibodies within 6 months.
  4. Received high doses of glucocorticoid (>10 mg/d) within 1 month.
  5. 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)
  6. Known allergies, hyperreactivity or intolerance of tofacitinib or its excipients.
  7. 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.
  8. 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.
  9. 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).
  10. 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.
  11. Pregnant, lactating women (WCBP) are reluctant to use medically approved contraceptives during treatment and 12 months after treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05087589


Contacts
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Contact: Qinghong Liu +86 15774917676 166618530@qq.com
Contact: Jing He +86 18611707347 hejing1105@126.com

Locations
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China, Beijing
Department of Rheumatology and Immunology, Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: Jing He, MD and PhD    +8618611707347    hejing1105@gmail.com   
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Zhanguo Li Peking University Institute of Rheuamotology and Immunology
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Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT05087589    
Other Study ID Numbers: 20210918pss
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: November 16, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Sjogren's Syndrome
Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action