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

Primary Purpose

Primary Sjögren's Syndrome

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tofacitinib
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Sjögren's Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Rheumatology and Immunology, Peking University People's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tofacitinib

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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% .
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.

Full Information

First Posted
October 8, 2021
Last Updated
February 28, 2022
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05087589
Brief Title
Efficacy, Safety and Immunological Evaluation of Tofacitinib in the Treatment of Primary Sjogren's Syndrome
Official Title
Efficacy, Safety and Immunological Evaluation of Tofacitinib in the Treatment of Primary Sjögren's Syndrome:a Prospective Observational Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2021 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University People's Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Sjögren's Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tofacitinib
Arm Type
Experimental
Arm Description
Tofacitinib 5mg was taken orally twice a day for 6 months
Intervention Type
Drug
Intervention Name(s)
Tofacitinib
Intervention Description
Tofacitinib 5mg was taken orally twice a day for 6 months
Primary Outcome Measure Information:
Title
Immunological Responses
Description
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.
Time Frame
week 24
Secondary Outcome Measure Information:
Title
Improvements in EULAR SS patient-reported index (ESSPRI), other clinical and immunological parameters
Description
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% .
Time Frame
week 24
Title
Safety and tolerability of tofacitinib as assessed by incidence of adverse events reported and observed
Description
we will report frequency of adverse events.Adverse events includes infection, tumor, abnormal neutrophil and lymphocyte count, anemia,drug-induced liver and kidney damage.
Time Frame
up tp 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qinghong Liu
Phone
+86 15774917676
Email
166618530@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jing He
Phone
+86 18611707347
Email
hejing1105@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhanguo Li
Organizational Affiliation
Peking University Institute of Rheuamotology and Immunology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rheumatology and Immunology, Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing He, MD and PhD
Phone
+8618611707347
Email
hejing1105@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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